SchizophreniaPhase 2SZ-001NCT06245213
A Study of ANAVEX3-71 in Adults With Schizophrenia
A Phase 2 study testing ANAVEX3-71 oral capsules in people with Schizophrenia, run by Anavex Life Sciences Corp. at 1 site in United States.
Trial summary
A study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and electrophysiology of ANAVEX3-71 in patients with Schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- ANAVEX3-71 oral capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2024to 30 Jun 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female volunteers 18-55 years of age, inclusive at screening.
- Has a primary diagnosis of schizophrenia, for ≥ 1 year
- Stable schizophrenia psychiatric symptoms for at least 6 weeks prior to screening.
- Schizophrenia clinical symptom severity defined by meeting ALL of the following per the Positive and Negative Syndrome Scale (PANSS) item scores at screening:
- Delusions (P1) ≤ 4
- Hallucinatory behavior (P3) ≤ 4
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- Unusual thought content (G9) ≤ 4
- Hostility (P7) ≤ 4
- Patient has a PANSS total score ≤ 80 at screening and baseline visits and no worsening in PANSS total score between screening and baseline, of more than 20%.
- Has a Brief Assessment of Cognition (BACS) T-score < 50 at the screening visit.
- On a stable regimen of at least one and up to a maximum of two second-generation ("atypical") antipsychotic medications for at least 6 weeks prior to screening and agree to stay on this regimen for their entire study participation, with the following exceptions:
- Clozapine use is not permitted
- Quetiapine for sleep at doses less than 300 mg are permitted.
- Day time (including morning) quetiapine use as the background antipsychotic is not permitted.
- Able to understand the requirements of the study and able and willing to provide written informed consent and to abide by the study procedures, in the judgment of the Investigator, including able and willing to remain in an in-patient setting during the study.
- If of childbearing potential, using adequate contraceptive methods for the duration of the study.
- Body mass index of 18.5 to 40.0 kg/m2 (inclusive) and total body weight > 50 kg (110 lbs.) for males and > 40 kg (88 lbs.) for females.
- Has a negative urine screen for drugs of abuse and negative alcohol breath test at screening and check-in.
- Patient resides in a stable living situation and is anticipated to return to that same stable living situation.
Who cannot join
- Participation in a schizophrenia study in which the patient has received any investigational medications within 60 days prior to the baseline visit.
- History or presence of a clinically significant, poorly treated, or unstable conditions that would jeopardize the safety of the patient or the validity of the study results.
- Clinically significant abnormal findings on the physical examination, medical history, ECG, or clinical laboratory results at screening.
- Calgary Depression Scale for schizophrenia (CDSS) score ≥6 at the screening or baseline visits.
- Simpson Angus Scale (SAS) total score ≥5 at the screening and baseline visits at the screening or baseline visits.
- Abnormal Involuntary Movement (AIMS) score of 2 for two or more movements or a score of 3 or 4 for any single movement on this scale at the screening or baseline visits.
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- Any primary the DSM-5-TR (American Psychiatric Association 2022) disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening).
- Pregnant, lactating, or less than 3 months postpartum. Sperm donation is not allowed for 90 days after the final dose of study drug.
- Risk for suicidal behavior during the study.
- Inability to detect a 1000 Hz tone at 40 dB in both ears at screening.
- Has psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
CenExel Hassman Research Institute
Marlton, New Jersey, 08053
About this study
Official title: A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Electrophysiology of ANAVEX3-71 in Adult Patients With Schizophrenia in a Multiple Ascending Dose Study (Part A), Followed by a Double-Blind, Randomized, Placebo-Controlled Study (Part B)
A study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and electrophysiology of ANAVEX3-71 in patients with Schizophrenia.
Read the detailed description
ANAVEX3-71-SZ-001 is a two-part study. The first part is Part A: Multiple Ascending Dose, PK, safety, and dose selection. The second part is Part B: Double Blind, Placebo Controlled for exploratory efficacy and continued repeat-dose safety. This study will investigate the effects of ANAVEX3-71 in patients with Schizophrenia for the first time. This is an in-patient study. In both parts, participants will undergo either 10 or 28 days of dosing (Part A and Part B, respectively). Standard clinical outcome measures used in the clinic and novel fluid and electrophysiological biomarkers will also be assessed.
- Conditions
- Schizophrenia
- Being tested
- ANAVEX3-71 oral capsules, Placebo oral capsules
- Keywords
- Schizophrenia, EEG, Multiple Ascending Dose, Interventional, Sigma-1 Receptor Agonist, M1 Muscarinic Receptor Agonist, Biomarkers, Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANAVEX3-71 oral capsulesDrug
ANAVEX®3-71 (formerly AF710B) is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator with agonistic effects. This novel mechanism of action offers the potential to treat all symptom domains (positive, negative, and cognitive) of schizophrenia without the side effects of standard of care antipsychotics.
Placebo oral capsulesDrug
The placebo comparator for the study.
| Study group | Role | What they receive |
|---|---|---|
| ANAVEX3-71 30 mg TID (Part A) | Active comparator | The first active treatment arm of the study during Part A (multiple ascending doses). Receives: Drug: ANAVEX3-71 oral capsules |
| ANAVEX3-71 60 mg TID (Part A) | Active comparator | The second active treatment arm of the study during Part A (multiple ascending doses). Receives: Drug: ANAVEX3-71 oral capsules |
| ANAVEX3-71 Placebo TID (Part A) | Placebo comparator | The placebo arm of Part A (multiple ascending doses). Receives: Drug: Placebo oral capsules |
| ANAVEX3-71 TBD mg TID (Part B) | Active comparator | The active arm of Part B of the study. The dose will be determined based on data obtained in Part A. Receives: Drug: ANAVEX3-71 oral capsules |
| ANAVEX3-71 Placebo TID (Part B) | Placebo comparator | The placebo arm of Part B of the study. Receives: Drug: Placebo oral capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Dose Maximum Observed Plasma Concentration (Cmax)
Pharmacokinetic blood measurements of ANAVEX3-71 and metabolite M8 at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose.
Measured: Part A: Day 1
Multiple Dose Maximum Observed Plasma Concentration (Cmax)
Pharmacokinetic blood measurements of ANAVEX3-71 and metabolite M8 at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose.
Measured: Part A: Day 1 and Day 9
Cmax (steady state)
The maximum plasma concentration of ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
Measured: Part A: Day 1 and Day 9
Tmax (steady state)
The time to maximum plasma concentration of ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
Measured: Part A: Day 1 and Day 9
AUC (steady state)
The area under the curve of the plasma concentration of ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
Measured: Part A: Day 1 and Day 9
AUC (single state)
The area under the curve of the plasma concentration of ANAVEX3-71 and metabolite M8 after a single day of dosing. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
Measured: Part A: Day 1 and Day 9
CL/F (steady state)
The oral clearance of ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
Measured: Part A: Day 1 and Day 9
Vz/F (steady state)
The volume of distribution based on the terminal elimination phase following administration ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
Measured: Part A: Day 1 and Day 9
T1/2 (steady state)
The time to elimination of half the quantity of ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
Measured: Part A: Day 1 and Day 9
Rac (steady state)
The observed accumulation rate of ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
Measured: Part A: Day 1 and Day 9
Rac, Cmax (steady state)
The observed accumulation ratio for Cmax of ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
Measured: Part A: Day 1 and Day 9
PTR (steady state)
The peak-to-trough ratio at steady state for ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
Measured: Part A: Day 1 and Day 9
Adverse Events
Safety as measured by the number of participants with treatment-related adverse events and the number of treatment-related adverse events, as assessed by CTCAE v4.0.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Vital Signs
Safety as measured by changes in vital signs including heart rate (beats per minute), blood pressure (mmHg), respiration rate (breaths per minute), and body temperature (degrees centigrade). These measurements will be reported together for the investigator to assess their clinical relevance and relation to potential treatment emergent adverse events.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
12-lead ECG (RR interval)
Safety as measured by changes in the time elapsed between two successive R-waves of the QRS signal on the electrocardiogram (in seconds).
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
12-lead ECG (P wave)
Safety as measured by changes in the electrical depolarization of the atria of the heart (in milliseconds).
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
12-lead ECG (PR interval)
Safety as measured by changes in the conduction between the atria and ventricles (in milliseconds).
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
12-lead ECG (PR segment)
Safety as measured by changes in the portion of the ECG from the end of the P wave to the beginning of the QRS complex as measured by the electrocardiogram.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
12-lead ECG (QRS complex)
Safety as measured by changes in ventricular depolarization as measured by the Q, R, and S waves on the electrocardiogram.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
12-lead ECG (ST segment)
Safety as measured by changes in the interval between ventricular depolarization and repolarization as represented by the end of the S wave and beginning of the T wave on the electrocardiogram.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
12-lead ECG (T wave)
Safety as measured by changes in ventricular repolarization (in milliseconds).
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
12-lead ECG (QT interval)
Safety as measured by changes in ventricular depolarization and repolarization as represented by the interval between the QRS complex to the end of the T wave.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Clinical Safety Labs - Renal Panel
Safety as measured by changes in clinical safety laboratory parameters including glucose, calcium, phosphorus, blood urea nitrogen, creatinine, sodium, potassium, chloride, and bicarbonate. These measurements will be combined to report whether clinical safety labs are abnormal and/or clinically significant by the investigator.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Clinical Safety Labs - Hepatic Panel
Safety as measured by changes in clinical safety laboratory parameters including albumin, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total bilirubin, direct bilirubin, indirect bilirubin, total protein, lactate dehydrogenase, and gamma-glutamyl transferase. These measurements will be combined to report whether clinical safety labs are abnormal and/or clinically significant by the investigator.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Clinical Safety Labs - Lipid Panel
Safety as measured by changes in clinical safety laboratory parameters including triglycerides, cholesterol (low-density lipoprotein [LDL], high-density lipoprotein [HDL]), and creatine phosphokinase.These measurements will be combined to report whether clinical safety labs are abnormal and/or clinically significant by the investigator.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Clinical Safety Labs - Hematology Panel
Safety as measured by changes in clinical safety laboratory parameters including Red blood cell (RBC) count, hemoglobin, hematocrit, white blood cell counts with differential, platelet count, RBC indices (mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], and mean corpuscular hemoglobin concentration [MCHC]) and if RBC indices are abnormal, and reflex to RBC morphology if indices are abnormal.These measurements will be combined to report whether clinical safety labs are abnormal and/or clinically significant by the investigator.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Clinical Safety Labs - Urinalysis Panel
Safety as measured by changes in clinical safety laboratory parameters including Protein, glucose, pH, blood, leukocytes, leukocyte esterase, urobilinogen, bilirubin, ketones, and nitrite. These measurements will be combined to report whether clinical safety labs are abnormal and/or clinically significant by the investigator.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Clinical Safety Labs - Coagulation Panel
Safety as measured by changes in clinical safety laboratory parameters including activated partial thromboplastin time, prothrombin time, and international normalized ratio.These measurements will be combined to report whether clinical safety labs are abnormal and/or clinically significant by the investigator.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Brief Physical Examination
Safety as measured by changes in the general appearance of nails, skin, hair, body habitus, movement coordination, odors, breathing pattern, eyes, ears, nose, mouth, face, salivary glands, lymph nodes, thyroid, anterior and posterior torso, proximal/distal motor strength, and distal pulses. These measurements are combined to assess the general neurological status of the participant to report abnormalities and/or clinical significance by the investigator.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Brief Neurological Examination
Safety as measured by changes in the participant's mental status, gait, truncal stability, motor function, and visual capabilities. These measurements are combined to assess the general neurological status of the participant to report abnormalities and/or clinical significance by the investigator.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
AIMS
Safety as measured by changes in the Abnormal Involuntary Movement Scale (AIMS). This is a rating scale that was designed to measure involuntary movements known as tardive dyskinesia (TD), which sometimes develops as a side effect of long-term treatment with neuroleptic (anti-psychotic) medications. The test, which can be completed in about 5 minutes, has a total of twelve items rating involuntary movements of various areas of the patient's body. Items are scored on a 0 (none) to 4 (severe) basis; the scale provides a total score (items 1 through 7) or item 8 can be used in isolation as an indication of overall severity of symptoms.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
SAS
Safety as measured by changes in the Simpson-Angus Scale (SAS), administered typically within 5 minutes, it is a performance scale that measures anti-psychotic-induced parkinsonism symptoms. The rater asks the patient to perform 10 tasks and rates responses on a scale of 0-4 (normal to severe).
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
BARS
The Brief Adherence Rating Scale (BARS), administered typically within 5 minutes, is a 4-item questionnaire to assess a patient's adherence with their currently prescribed medication regimen. Medication non-adherence is common in patients with psychiatric conditions and associated with worse clinical outcomes. The BARS assesses a patient's compliance with their prescribed medication regimen. The tool is administered by a clinician and includes 4 items: 3 questions and an overall visual analog rating scale to estimate the proportion of doses taken by the patient in the past month (0-100%). The three questions probe patients' knowledge about their medication regimen: number of prescribed doses per day, number of days the patient did not take the prescribe dose, and number of days the patient took less than the prescribed dose.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
CDSS
The Calgary Depression Scale for Schizophrenia (CDSS) is a 9-item clinician-rated outcome measure that assesses the level of depression in people with schizophrenia spectrum disorder, including attenuated psychosis syndrome. It distinguishes depressive symptoms from negative, positive, and extrapyramidal symptoms. The scales take approximately 10 minutes to administer and has a lookback period of 2-weeks. Each item is rated on a scale of 0-3 (absent to severe).
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
C-SSRS
The Columbia Suicide Severity Rating Scale (C-SSRS) is a suicidal ideation rating scale. The scale identifies behaviors and thoughts that are associated with an increased risk of suicidal actions in the future. The C-SSRS baseline/screening version will be conducted at screening. The C-SSRS Since Last Visit version will be conducted for all visits after screening. Answers are "Yes" or "No" with the opportunity for the participant to explain their answers further.
Measured: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
EEG-ERP - Passive, Duration Deviant, Oddball ERP
Electroencephalography (EEG) and event-related potential (ERP) measures of the duration deviant mismatch negativity paradigm. In this paradigm, 2 tones of the same frequency and sound intensity, one short duration (Standard) and one longer duration (Deviant), are sequentially presented to the patient through inserted earphones. Standard stimuli are presented more often than Deviant stimuli. While the auditory stimuli are being played, the patient is instructed to perform a picture-word matching task where they press a button on the COGNISON® handset when they see a picture and a word on a monitor positioned in front of them that do not match.
Measured: Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
EEG-ERP - Active, Auditory, Oddball ERP
Electroencephalography (EEG) and event-related potential (ERP) measures. In this paradigm, 2 tones of the same sound intensity, one low frequency (Standard) and one higher frequency (Target) are sequentially presented to the patient through inserted earphones. The Standard stimuli are presented more often than the Target stimuli. The patient is told to listen for the high-frequency stimuli (Target) and press a button on the COGNISION® handset as fast as they can.
Measured: Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
EEG-ERP - Auditory Steady State Response
Electroencephalography (EEG) and event-related potential (ERP) measures. In this paradigm, a short stream of clicks is repeatedly presented to the patient through inserted earphones. While the click-streams are being presented, the patient is instructed to fix their gaze on a white cross displayed on a computer monitor positioned in front of them.
Measured: Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
EEG-ERP - Resting EEG
Electroencephalography (EEG) and event-related potential (ERP) measures. In this paradigm, the patient is asked to close their eyes and relax for 5 minutes while EEGs are recorded.
Measured: Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
Secondary outcomes (8)
Positive and Negative Syndrome Scale (PANSS)
The Positive and Negative Syndrome Scale (PANSS) is an approximate 30-minute structured interview scale used for measuring the symptom severity of patients with schizophrenia. It is widely used in the study of antipsychotic therapy.
Measured: Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
Brief Assessment of Cognition in Schizophrenia (BACS)
The Brief Assessment of Cognition in Schizophrenia (BACS) assesses the aspects of cognition found to be most impaired and most strongly correlated with outcomes in patients with schizophrenia. The BACS requires less than 35 min to complete.
Measured: Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
Clinical Global Impressions Scale Schizophrenia (CGI-SCH)
The Clinical Global Impression-Schizophrenia Scale (CGI-SCH) assesses the positive, negative, depressive, cognitive symptoms, and overall severity of schizophrenia. The (CGI-SCH) scale is a brief assessment instrument which is originally adapted from the Clinical Global Impression (CGI) scale and the CGI Bipolar Patients (CGI-BP) scale. It was developed to study the outcome of antipsychotic treatment in schizophrenia in an observational study (Schizophrenia Outpatient Health Outcomes (SOHO) Study. The CGI-SCH has shown strong validity, and it has slightly higher interrater reliability than the PANSS (Kumari et al., 2017).
Measured: Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) is a computerized measure that was developed to be a reliable, valid, and sensitive measure of functional capacity, with the potential to demonstrate real-world functional improvements associated with cognitive change. The VRFCAT, typically administered within 15 minutes, presents patients with a realistic simulated environment to re-create routine activities of daily living, including, e.g., exploring a kitchen, catching a bus to a grocery store, finding/purchasing food in a grocery store, and returning home on a bus. To permit repeated testing while avoiding learning effects, 6 alternate forms were created that vary the ingredients stored in the cabinets, items on the recipe and grocery list, cost of the bus rides, cost of groceries, and money available in a wallet.
Measured: Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
Blood measurements of chitinase-3-like protein 1 (YKL-40)
Previous studies have identified genetic variants of the chitinase-3-like protein 1 gene (which expresses YKL-40) and elevated serum YKL-40 with an increased risk for schizophrenia in certain populations (Ohi et al., 2010). Subsequent studies in broader populations demonstrated monocyte activation and elevated YKL-40 in the plasma and cerebrospinal fluid of patients experiencing first-episode psychosis (Orhan et al., 2018). This study seeks to explore blood levels of YKL-40 before and after treatment with ANAVEX3-71 to investigate the immune calming effects associated with Sigma-1 receptor activation in patients with schizophrenia. The expected effect of Sigma-1 activation on inflammation may be an upstream effect by attenuating disease-related, chronic pro-inflammatory signaling by monocytes and glia, to prevent downstream injury due to inflammation (Zhang et al., 2023).
Measured: Part B: Baseline to End of Treatment (Day -2 to Day 28)
Blood measurements of glial fibrillary acidic protein (GFAP)
Immune dysfunction theories of schizophrenia include glial-related dysfunction and assume that initial disturbances in glial cells can lead or contribute to neuronal abnormalities that drive symptoms of schizophrenia. Glial perturbations in schizophrenia are associated with a neuroinflammatory response and elevated levels of glial fibrillary acidic protein (GFAP) (Wang et al., 2015).
Measured: Part B: Baseline to End of Treatment (Day -2 to Day 28)
Blood measurements of circulating amino acid metabolites
Changes in the metabolomic profile of circulating amino acids and related metabolites are implicated in the etiology of numerous neurological and neuropsychiatric disorders (Donatti et al., 2020). Metabolomics studies of patients with schizophrenia demonstrate numerous metabolite signatures of schizophrenia including elevated glutamate (Davison et al., 2018). Changes in these metabolite levels may result from treatment, based on previous research into the treatment of other central nervous system disorders with Sigma-1 receptor agonists such as ANAVEX3-71.
Measured: Part B: Baseline to End of Treatment (Day -2 to Day 28)
Exploratory DNA/RNA, including whole genome analysis and whole transcriptome mRNA
Exploratory DNA/RNA, including whole genome analysis and whole transcriptome mRNA. Assessed in whole blood via next generation sequencing (NGS) method. Whole genome sequencing (WGS) with 30x read depth. These measurements will be used to understand the potential effects of genetic variation on treatment response and the potential effect of treatment on changes in gene expression which may be relevant to the etiology of schizophrenia.
Measured: Part B: Baseline to End of Treatment (Day -2 to Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start15 Mar 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment in Part A and Part B. Part A: n = 16; Part B: n = 55;
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anavex Life Sciences Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- COGNISION, Cognitive Research Corporation, Hassman Research Institute
- Responsible party
- Principal investigator, Kathy Skoff, Anavex Life Sciences Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245213
- Sponsor's protocol ID
- ANAVEX3-71-SZ-001
- Acronym
- SZ-001
- Status last verified
- Apr 2025
- First submitted
- 19 Jan 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Electrophysiology of ANAVEX3-71 in Adult Patients With Schizophrenia in a Multiple Ascending Dose Study (Part A), Followed by a Double-Blind, Randomized, Placebo-Controlled Study (Part B)
- ClinicalTrials.gov ID
- NCT06245213
- Acronym / sponsor ID
- SZ-001 / ANAVEX3-71-SZ-001
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, EEG, Multiple Ascending Dose, Interventional, Sigma-1 Receptor Agonist, M1 Muscarinic Receptor Agonist, Biomarkers, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Anavex Life Sciences Corp.Industry (pharma, biotech, devices)
- Collaborators
- COGNISION, Cognitive Research Corporation, Hassman Research Institute
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and electrophysiology of ANAVEX3-71 in patients with Schizophrenia.
Detailed description
ANAVEX3-71-SZ-001 is a two-part study. The first part is Part A: Multiple Ascending Dose, PK, safety, and dose selection. The second part is Part B: Double Blind, Placebo Controlled for exploratory efficacy and continued repeat-dose safety. This study will investigate the effects of ANAVEX3-71 in patients with Schizophrenia for the first time. This is an in-patient study. In both parts, participants will undergo either 10 or 28 days of dosing (Part A and Part B, respectively). Standard clinical outcome measures used in the clinic and novel fluid and electrophysiological biomarkers will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Parallel Assignment in Part A and Part B. Part A: n = 16; Part B: n = 55;
| Arm | Type | Receives |
|---|---|---|
| ANAVEX3-71 30 mg TID (Part A) | Active comparator | Drug: ANAVEX3-71 oral capsulesThe first active treatment arm of the study during Part A (multiple ascending doses). |
| ANAVEX3-71 60 mg TID (Part A) | Active comparator | Drug: ANAVEX3-71 oral capsulesThe second active treatment arm of the study during Part A (multiple ascending doses). |
| ANAVEX3-71 Placebo TID (Part A) | Placebo comparator | Drug: Placebo oral capsulesThe placebo arm of Part A (multiple ascending doses). |
| ANAVEX3-71 TBD mg TID (Part B) | Active comparator | Drug: ANAVEX3-71 oral capsulesThe active arm of Part B of the study. The dose will be determined based on data obtained in Part A. |
| ANAVEX3-71 Placebo TID (Part B) | Placebo comparator | Drug: Placebo oral capsulesThe placebo arm of Part B of the study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Male and female volunteers 18-55 years of age, inclusive at screening.
- Has a primary diagnosis of schizophrenia, for ≥ 1 year
- Stable schizophrenia psychiatric symptoms for at least 6 weeks prior to screening.
- Schizophrenia clinical symptom severity defined by meeting ALL of the following per the Positive and Negative Syndrome Scale (PANSS) item scores at screening:
- Patient has a PANSS total score ≤ 80 at screening and baseline visits and no worsening in PANSS total score between screening and baseline, of more than 20%.
Key exclusion criteria (11 listed)
- Participation in a schizophrenia study in which the patient has received any investigational medications within 60 days prior to the baseline visit.
- History or presence of a clinically significant, poorly treated, or unstable conditions that would jeopardize the safety of the patient or the validity of the study results.
- Clinically significant abnormal findings on the physical examination, medical history, ECG, or clinical laboratory results at screening.
- Calgary Depression Scale for schizophrenia (CDSS) score ≥6 at the screening or baseline visits.
- Simpson Angus Scale (SAS) total score ≥5 at the screening and baseline visits at the screening or baseline visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANAVEX3-71 oral capsulesANAVEX®3-71 (formerly AF710B) is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator with agonistic effects. This novel mechanism of action offers the potential to treat all symptom domains (positive, negative, and cognitive) of schizophrenia without the side effects of standard of care antipsychotics. | Drug | ANAVEX3-71 30 mg TID (Part A), ANAVEX3-71 60 mg TID (Part A), ANAVEX3-71 TBD mg TID (Part B) |
| Placebo oral capsulesThe placebo comparator for the study. | Drug | ANAVEX3-71 Placebo TID (Part A), ANAVEX3-71 Placebo TID (Part B) |
Primary outcome
Single Dose Maximum Observed Plasma Concentration (Cmax)
Time frame: Part A: Day 1
Pharmacokinetic blood measurements of ANAVEX3-71 and metabolite M8 at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose.
Multiple Dose Maximum Observed Plasma Concentration (Cmax)
Time frame: Part A: Day 1 and Day 9
Pharmacokinetic blood measurements of ANAVEX3-71 and metabolite M8 at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose.
Cmax (steady state)
Time frame: Part A: Day 1 and Day 9
The maximum plasma concentration of ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
Tmax (steady state)
Time frame: Part A: Day 1 and Day 9
The time to maximum plasma concentration of ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
AUC (steady state)
Time frame: Part A: Day 1 and Day 9
The area under the curve of the plasma concentration of ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
AUC (single state)
Time frame: Part A: Day 1 and Day 9
The area under the curve of the plasma concentration of ANAVEX3-71 and metabolite M8 after a single day of dosing. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
CL/F (steady state)
Time frame: Part A: Day 1 and Day 9
The oral clearance of ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
Vz/F (steady state)
Time frame: Part A: Day 1 and Day 9
The volume of distribution based on the terminal elimination phase following administration ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
T1/2 (steady state)
Time frame: Part A: Day 1 and Day 9
The time to elimination of half the quantity of ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
Rac (steady state)
Time frame: Part A: Day 1 and Day 9
The observed accumulation rate of ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
Rac, Cmax (steady state)
Time frame: Part A: Day 1 and Day 9
The observed accumulation ratio for Cmax of ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
PTR (steady state)
Time frame: Part A: Day 1 and Day 9
The peak-to-trough ratio at steady state for ANAVEX3-71 and metabolite M8 after reaching a steady state. With measurements taken at pre-dose, 0.5, 1, 2-, 3-, 4-, and 8-hours post-dose on Days 1 and 9.
Adverse Events
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by the number of participants with treatment-related adverse events and the number of treatment-related adverse events, as assessed by CTCAE v4.0.
Vital Signs
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in vital signs including heart rate (beats per minute), blood pressure (mmHg), respiration rate (breaths per minute), and body temperature (degrees centigrade). These measurements will be reported together for the investigator to assess their clinical relevance and relation to potential treatment emergent adverse events.
12-lead ECG (RR interval)
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in the time elapsed between two successive R-waves of the QRS signal on the electrocardiogram (in seconds).
12-lead ECG (P wave)
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in the electrical depolarization of the atria of the heart (in milliseconds).
12-lead ECG (PR interval)
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in the conduction between the atria and ventricles (in milliseconds).
12-lead ECG (PR segment)
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in the portion of the ECG from the end of the P wave to the beginning of the QRS complex as measured by the electrocardiogram.
12-lead ECG (QRS complex)
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in ventricular depolarization as measured by the Q, R, and S waves on the electrocardiogram.
12-lead ECG (ST segment)
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in the interval between ventricular depolarization and repolarization as represented by the end of the S wave and beginning of the T wave on the electrocardiogram.
12-lead ECG (T wave)
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in ventricular repolarization (in milliseconds).
12-lead ECG (QT interval)
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in ventricular depolarization and repolarization as represented by the interval between the QRS complex to the end of the T wave.
Clinical Safety Labs - Renal Panel
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in clinical safety laboratory parameters including glucose, calcium, phosphorus, blood urea nitrogen, creatinine, sodium, potassium, chloride, and bicarbonate. These measurements will be combined to report whether clinical safety labs are abnormal and/or clinically significant by the investigator.
Clinical Safety Labs - Hepatic Panel
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in clinical safety laboratory parameters including albumin, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total bilirubin, direct bilirubin, indirect bilirubin, total protein, lactate dehydrogenase, and gamma-glutamyl transferase. These measurements will be combined to report whether clinical safety labs are abnormal and/or clinically significant by the investigator.
Clinical Safety Labs - Lipid Panel
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in clinical safety laboratory parameters including triglycerides, cholesterol (low-density lipoprotein [LDL], high-density lipoprotein [HDL]), and creatine phosphokinase.These measurements will be combined to report whether clinical safety labs are abnormal and/or clinically significant by the investigator.
Clinical Safety Labs - Hematology Panel
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in clinical safety laboratory parameters including Red blood cell (RBC) count, hemoglobin, hematocrit, white blood cell counts with differential, platelet count, RBC indices (mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], and mean corpuscular hemoglobin concentration [MCHC]) and if RBC indices are abnormal, and reflex to RBC morphology if indices are abnormal.These measurements will be combined to report whether clinical safety labs are abnormal and/or clinically significant by the investigator.
Clinical Safety Labs - Urinalysis Panel
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in clinical safety laboratory parameters including Protein, glucose, pH, blood, leukocytes, leukocyte esterase, urobilinogen, bilirubin, ketones, and nitrite. These measurements will be combined to report whether clinical safety labs are abnormal and/or clinically significant by the investigator.
Clinical Safety Labs - Coagulation Panel
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in clinical safety laboratory parameters including activated partial thromboplastin time, prothrombin time, and international normalized ratio.These measurements will be combined to report whether clinical safety labs are abnormal and/or clinically significant by the investigator.
Brief Physical Examination
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in the general appearance of nails, skin, hair, body habitus, movement coordination, odors, breathing pattern, eyes, ears, nose, mouth, face, salivary glands, lymph nodes, thyroid, anterior and posterior torso, proximal/distal motor strength, and distal pulses. These measurements are combined to assess the general neurological status of the participant to report abnormalities and/or clinical significance by the investigator.
Brief Neurological Examination
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in the participant's mental status, gait, truncal stability, motor function, and visual capabilities. These measurements are combined to assess the general neurological status of the participant to report abnormalities and/or clinical significance by the investigator.
AIMS
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in the Abnormal Involuntary Movement Scale (AIMS). This is a rating scale that was designed to measure involuntary movements known as tardive dyskinesia (TD), which sometimes develops as a side effect of long-term treatment with neuroleptic (anti-psychotic) medications. The test, which can be completed in about 5 minutes, has a total of twelve items rating involuntary movements of various areas of the patient's body. Items are scored on a 0 (none) to 4 (severe) basis; the scale provides a total score (items 1 through 7) or item 8 can be used in isolation as an indication of overall severity of symptoms.
SAS
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
Safety as measured by changes in the Simpson-Angus Scale (SAS), administered typically within 5 minutes, it is a performance scale that measures anti-psychotic-induced parkinsonism symptoms. The rater asks the patient to perform 10 tasks and rates responses on a scale of 0-4 (normal to severe).
BARS
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
The Brief Adherence Rating Scale (BARS), administered typically within 5 minutes, is a 4-item questionnaire to assess a patient's adherence with their currently prescribed medication regimen. Medication non-adherence is common in patients with psychiatric conditions and associated with worse clinical outcomes. The BARS assesses a patient's compliance with their prescribed medication regimen. The tool is administered by a clinician and includes 4 items: 3 questions and an overall visual analog rating scale to estimate the proportion of doses taken by the patient in the past month (0-100%). The three questions probe patients' knowledge about their medication regimen: number of prescribed doses per day, number of days the patient did not take the prescribe dose, and number of days the patient took less than the prescribed dose.
CDSS
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
The Calgary Depression Scale for Schizophrenia (CDSS) is a 9-item clinician-rated outcome measure that assesses the level of depression in people with schizophrenia spectrum disorder, including attenuated psychosis syndrome. It distinguishes depressive symptoms from negative, positive, and extrapyramidal symptoms. The scales take approximately 10 minutes to administer and has a lookback period of 2-weeks. Each item is rated on a scale of 0-3 (absent to severe).
C-SSRS
Time frame: Part A and Part B Screening to Safety Follow Up Visit; Up to 78 days (Part A) and Up to 114 days (Part B)
The Columbia Suicide Severity Rating Scale (C-SSRS) is a suicidal ideation rating scale. The scale identifies behaviors and thoughts that are associated with an increased risk of suicidal actions in the future. The C-SSRS baseline/screening version will be conducted at screening. The C-SSRS Since Last Visit version will be conducted for all visits after screening. Answers are "Yes" or "No" with the opportunity for the participant to explain their answers further.
EEG-ERP - Passive, Duration Deviant, Oddball ERP
Time frame: Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
Electroencephalography (EEG) and event-related potential (ERP) measures of the duration deviant mismatch negativity paradigm. In this paradigm, 2 tones of the same frequency and sound intensity, one short duration (Standard) and one longer duration (Deviant), are sequentially presented to the patient through inserted earphones. Standard stimuli are presented more often than Deviant stimuli. While the auditory stimuli are being played, the patient is instructed to perform a picture-word matching task where they press a button on the COGNISON® handset when they see a picture and a word on a monitor positioned in front of them that do not match.
EEG-ERP - Active, Auditory, Oddball ERP
Time frame: Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
Electroencephalography (EEG) and event-related potential (ERP) measures. In this paradigm, 2 tones of the same sound intensity, one low frequency (Standard) and one higher frequency (Target) are sequentially presented to the patient through inserted earphones. The Standard stimuli are presented more often than the Target stimuli. The patient is told to listen for the high-frequency stimuli (Target) and press a button on the COGNISION® handset as fast as they can.
EEG-ERP - Auditory Steady State Response
Time frame: Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
Electroencephalography (EEG) and event-related potential (ERP) measures. In this paradigm, a short stream of clicks is repeatedly presented to the patient through inserted earphones. While the click-streams are being presented, the patient is instructed to fix their gaze on a white cross displayed on a computer monitor positioned in front of them.
EEG-ERP - Resting EEG
Time frame: Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
Electroencephalography (EEG) and event-related potential (ERP) measures. In this paradigm, the patient is asked to close their eyes and relax for 5 minutes while EEGs are recorded.
8 secondary outcomes
Positive and Negative Syndrome Scale (PANSS)
Time frame: Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
Brief Assessment of Cognition in Schizophrenia (BACS)
Time frame: Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
Clinical Global Impressions Scale Schizophrenia (CGI-SCH)
Time frame: Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
Time frame: Part A and Part B: Up to 12 days (Part A) and Up to 30 days (PartB)
Blood measurements of chitinase-3-like protein 1 (YKL-40)
Time frame: Part B: Baseline to End of Treatment (Day -2 to Day 28)
Blood measurements of glial fibrillary acidic protein (GFAP)
Time frame: Part B: Baseline to End of Treatment (Day -2 to Day 28)
Blood measurements of circulating amino acid metabolites
Time frame: Part B: Baseline to End of Treatment (Day -2 to Day 28)
Exploratory DNA/RNA, including whole genome analysis and whole transcriptome mRNA
Time frame: Part B: Baseline to End of Treatment (Day -2 to Day 28)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ANAVEX3-71 oral capsules in people with Schizophrenia, run by Anavex Life Sciences Corp. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single Dose Maximum Observed Plasma Concentration (Cmax) (time frame: Part A: Day 1). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.