Schizophrenia, Schizoaffective DisorderPhase 2NCT03669640
A Study to Assess the Effects of RO6889450 (Ralmitaront) in Participants With Schizophrenia or Schizoaffective Disorder and Negative Symptoms
A Phase 2 study testing RO6889450 in people with Schizophrenia, Schizoaffective Disorder, run by Hoffmann-La Roche at 45 sites in 4 countries.
Trial summary
This study investigates the effects of RO6889450 on the negative symptoms associated with schizophrenia and schizoaffective disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- RO6889450
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 45 sitesin 4 countries
- Study dates
- 4 Dec 2018to 12 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI)
- Part B only: Stable treatment with a dopamine/serotonin (D2/5HT2A) antagonist or pure D2 antagonist(s), or a D2 partial agonist for a minimum of 6 months and receiving no more than two antipsychotics
- Medically stable during the 3 months prior to study entry
- Participant is an outpatient with no psychiatric hospitalizations within the prior 6 months
- PANSS negative symptom factor score of 18 or higher
- The following rating on items of the PANSS: (a) less than 5 on G8 (uncooperativeness), P1 (delusions), P3 (hallucinations), P4 (excitement/hyperactivity), and P6 (suspiciousness/persecution); (b) less than 4 on P7 (hostility), and G14 (poor impulse control)
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- Has an informant who is considered reliable by the Investigator
- Body mass index (BMI) between 18-40 kg/m2 inclusive
- Female participants are eligible to participate if not pregnant, not breastfeeding and agree to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 28 days after the last dose of study drug
Who cannot join
- Moderate to severe substance use disorder within six months of study entry (excluding nicotine or caffeine) as defined by DSM-5
- Extrapyramidal symptom rating scale (ESRS-A CGI) subscore greater than or equal to 3
- Other current DSM-5 diagnosis (e.g., bipolar disorder, major depressive disorder)
- PANSS item G6 (depression) greater than or equal to 5
- Significant risk of suicide or harming him- or herself or others according to the Investigator's judgment
- A prior or current general medical condition that might be impairing cognition or other psychiatric functioning
Show all 20Show fewer
- Positive result at screening for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or HIV-1 and HIV-2. HCV antibody positive participants are eligible if HCV RNA is negative
- Tardive dyskinesia that is moderate to severe or requires treatment
- History of neuroleptic malignant syndrome
- Average triplicate Fridericia's Correction Formula (QTcF) interval greater than 450 milliseconds (msec) for males and 470 msec for females or other clinically significant abnormality on screening electrocardiogram (ECG) based on centralized reading
- Clinically significant abnormalities in laboratory safety test results
- Significant or unstable physical condition that in the investigator's judgment might require a change in medication or hospitalization during the course of the study
- On more than one antidepressant, or if on one antidepressant, a change in dose within 28 days prior to screening
- History of clozapine treatment
- History of treatment with electroconvulsive therapy (ECT)
- Concomitant use of prohibited medications
- Positive urine drug screen for amphetamines, methamphetamines, opiates, buprenomorphine, methadone, cannabinoids, cocaine, and barbiturates
- Receipt of an investigational drug within 28 days or five times the half-life of the investigational drug (whichever is longer) before the first study drug administration
- Donation of blood over 400 mL within 3 months prior to screening
- Diagnosis of COVID-19 infection (confirmed or presumptive) 4 weeks prior to screening or during screening. Participants can be re-screened after 4 weeks of full recovery in addition to Investigator and/or institutional approval to enroll
Trial locations and contacts
45 sites in 4 countries.
45 sites in 4 countries
United States28 sites
Emory University
Atlanta, Georgia, 30329
CITrials, Inc.
Bellflower, California, 90706
Northwestern University
Chicago, Illinois, 60611-2908
Precise Research Centers
Flowood, Mississippi, 39232
JPS Health Network
Fort Worth, Texas, 76104
CBH Health
Gaithersburg, Maryland, 20877
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845
Pillar Clinical Research LLC
Garland, Texas, 75042
California Clinical Trials
Glendale, California, 91206
Baylor College of Medicine
Houston, Texas, 77030
University Hills Clinical Research
Irving, Texas, 75062
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319
Lifestream Behavioral Center
Leesburg, Florida, 34748
Synergy San Diego
Lemon Grove, California, 91945
Advanced Research Institute of Miami
Miami, Florida, 33135
The Solace Center
Missouri City, Texas, 77459
Catalina Research Institute LLC - MRA
Montclair, California, 91763
Yale School of Medicine - CT Mental Health Center (CMHC) - Schizophrenia Research Clinic
New Haven, Connecticut, 06519
Manhattan Psychiatric Center; Psychopharmacology Research Unit
New York, New York, 10035
Health Synergy Clinical Research
Okeechobee, Florida, 34972
Psychiatry & Behavioral Center
Richmond, Texas, 77406
@ Health Texas
Richmond, Texas, 77407
CITrials, Inc.
Riverside, California, 92506
California Neuropsychopharmacology Clinical Research Institute, LLC
San Diego, California, 92102
Psych Care Consultants Research
St Louis, Missouri, 63128
Millennium Psychiatric Associates, LLC
St Louis, Missouri, 63132
Stanford University School of Medicine
Stanford, California, 94305
Collaborative Neuroscience Network Inc.
Torrance, California, 90502
Ukraine7 sites
ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
Dnipro, KIEV Governorate, 49005
Communal Non-Commercial Enterprise of Kharkiv RC Regional clinical psychiatric hospital #3
Kharkiv, Kharkiv Governorate, 61068
Public NPE Kherson Regional Institution of Mental Care of Kherson RC
Kherson, Kherson Governorate, 73488
CNCE Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council
Nove, Katerynoslav Governorate, 25491
Municipal Non-Commercial Enterprise Odesa RMC for Mental Health of Odessa Regional Council
Odesa, Kherson Governorate, 65006
Zakarpattia Regional Clinical Hospital n.a. Andrii Novak
Uzhhorod, KIEV Governorate, 88000
Communal NPE Vinnytsia Reg. Clin. Psychoneurolog. Hosp. n.a. O.I. Yushchenko of Vinnytsia RC
Vinnytsia, Podolia Governorate, 21037
Japan5 sites
Kohnodai Hp., National Center for Global Health and Medicine
Chiba, 272-8516
National Hospital Organization Ryukyu Hospital
Kunigami, 904-1201
National Center of Neurology and Psychiatry
Tokyo, 187-8551
Seishinkai Okehazama Hospital Fujita Kokoro Care Center
Toyoake, 470-1168
Hiyoshi Hospital
Yokohama, 223-0062
Spain5 sites
C.H. Regional Reina Sofia - PPDS
Córdoba, 14004
Hosp Univ Fundacion Alcorcon
Madrid, 28922
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Complejo Asistencial Universitario de Salamanca ? H. Clinico
Salamanca, 37007
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
About this study
Official title: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of RO6889450 (Ralmitaront) in Patients With Schizophrenia or Schizoaffective Disorder and Negative Symptoms
This study investigates the effects of RO6889450 on the negative symptoms associated with schizophrenia and schizoaffective disorder.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- RO6889450, Placebo
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO6889450Drug
Participants will receive a once-daily, oral dose of RO6889450 for 12 weeks.
PlaceboDrug
Participants will receive a once-daily, oral dose of placebo matched to RO6889450 for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Monotherapy | Experimental | Participants will receive RO6889450 or a dose-matched placebo. NOTE: Part A has completed enrollment. Receives: Drug: RO6889450; Drug: Placebo |
| Part B: Add-On Therapy | Experimental | Participants will receive a low or high dose of RO6889450 or a dose-matched placebo in addition to their usual anti-psychotic treatment(s). Receives: Drug: RO6889450; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Negative Symptoms Scale (BNSS) Avolition/Apathy Subscore and Total Score at Baseline and Week 12
The BNSS is a 13-item instrument designed for clinical trials that measures the severity of the negative symptoms of schizophrenia in five domains. There are 13 items organized into 6 subscales (anhedonia, distress, asociality, avolition, blunted affect, and alogia), each rated on a 7-point scale (0-6) where 0 = absent symptoms and 6 = severe symptoms. The total score is calculated by summing the individual items (13) of each subscale and has a range of 0-78. The avolition/apathy subscale contains 2 items with a total score range of 0-12.
Measured: Baseline to Week 12
Secondary outcomes (12)
Clinical Global Impression Severity (CGI-S) Overall Scores
The CGI-S is an absolute measure assessing how mentally ill the participant is at the time of the assessment on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). On the scale, the value 0 corresponds to 'not assessed', which will be excluded from the analyses. The values 1 to 7 will be transformed into the 0 to 6 range prior to statistical analysis for the question on the measure ("Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?"), making the total score range 0-6.
Measured: Baseline to week 12
CGI-S Negative Symptoms (NS) Scores
The CGI-S-NS is similar to the CGI-S and is assessed on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). On the scale, the value 0 corresponds to 'not assessed', which will be excluded from the analyses. The values 1 to 7 will be transformed into the 0 to 6 range prior to statistical analysis for the question on the measure, making the total score range 0-6.
Measured: Baseline to week 12
Clinical Global Impression - Improvement (CGI-I) Overall Scores
The CGI-I assesses how much the participant's condition has changed at the time of the assessment in comparison to their condition at baseline. It uses a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), where the value 0 corresponds to 'not assessed' and will be excluded from any analyses.
Measured: Up to Week 12 (Day 84)
CGI-I Negative Symptoms Scores
The CGI-I NS is similar to the CGI-I and assesses how much the participant's condition has changed at the time of the assessment in comparison to their condition at baseline. It uses a 7-point scale, where:
- = Very much improved
- = Much improved
- = Minimally improved
- = No change
- = Minimally worse
- = Much worse
- = Very much worse
Measured: Up to Week 12 (Day 84)
Positive and Negative Syndrome Scale (PANSS) Total Scores
The PANSS Marder factors examine schizophrenia symptoms in five domains: positive symptoms, negative symptoms, disorganized thought, uncontrolled hostility/excitement, and depression/anxiety. The Marder factor positive symptom score (range = 8-56) measures responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12) while the negative symptom factor score (range = 7-49) consists of 7 items (N1,N2,N3,N4,N6,G7,G16). Each item is scored on a scale of 1-7, where 1 = an absence of symptoms and 7 = extreme symptoms. The positive and negative syndrome scale total score is the sum of the scores from each domain (range = 15-105); higher scores indicate greater severity of symptoms.
Measured: Baseline to week 12
PANSS Symptom Factor Scores
The PANSS Marder factors examine schizophrenia symptoms in five domains: positive symptoms, negative symptoms, disorganized thought, uncontrolled hostility/excitement, and depression/anxiety. The Marder factor positive symptom score (range = 8-56) measures responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12) while the negative symptom factor score (range = 7-49) consists of 7 items (N1,N2,N3,N4,N6,G7,G16). Each item is scored on a scale of 1-7, where 1 = an absence of symptoms and 7 = extreme symptoms.
Measured: Baseline to week 12
Brief Negative Symptom Scale (BNSS) Total Scores
The BNSS is a 13-item instrument designed for clinical trials that measures the severity of the negative symptoms of schizophrenia in five domains. There are 13 items organized into 6 subscales (anhedonia, distress, asociality, avolition, blunted affect, and alogia), each rated on a 7-point scale (0-6) where 0 = absent symptoms and 6 = severe symptoms. The total score is calculated by summing the individual items (13) of each subscale and has a range of 0-78.
Measured: Baseline to week 12
Defeatist Performance Attitude Scale (DPAS) Scores
The DPAS is a 15-item, patient-rated assessment that evaluates expectations of failures or self-defeating beliefs related to prior failed experiences as well as illness on a 7-point Likert scale (total range = 15-105) ranging from totally agree (1) to totally disagree (7).
Measured: Baseline to week 12
Number of Participants With Suicidal Ideation or Behavior, and Self-injurious Behavior Without Suicidal Intent on the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a suicide risk assessment tool used to help identify the risk of suicide.
Measured: Baseline through Day 84
Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A)
The ESRS-A is used to evaluate the presence and severity of extrapyramidal symptoms. Items are rated on a scale of 0 (no symptoms) to 5 (extreme symptoms).
Measured: Baseline through Day 84
Maximum Serum Concentration (Cmax) of RO6889450
Measured: Day 42
Area Under the Curve at Steady State (AUCss) of RO6889450
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start4 Dec 2018
- Primary completion12 Mar 2023
- Study completion12 Mar 2023
Why it stopped: This study was discontinued due to an interim analysis which indicated that ralmitaront was unlikely to meet its primary endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia, Schizoaffective DisorderStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669640
- Sponsor's protocol ID
- BP40283
- Status last verified
- Aug 2024
- First submitted
- 12 Sep 2018
- Last updated
- 12 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Halff EF, Rutigliano G, Garcia-Hidalgo A, Howes OD. Trace amine-associated receptor 1 (TAAR1) agonism as a new treatment strategy for schizophrenia and related disorders. Trends Neurosci. 2023 Jan;46(1):60-74. doi: 10.1016/j.tins.2022.10.010. Epub 2022 Nov 8.
PubMed 36369028
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of RO6889450 (Ralmitaront) in Patients With Schizophrenia or Schizoaffective Disorder and Negative Symptoms
- ClinicalTrials.gov ID
- NCT03669640
- Acronym / sponsor ID
- BP40283
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was discontinued due to an interim analysis which indicated that ralmitaront was unlikely to meet its primary endpoint.
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 12 Mar 2023 (actual)
- Study completion
- 12 Mar 2023 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Posted 12 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the effects of RO6889450 on the negative symptoms associated with schizophrenia and schizoaffective disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Monotherapy | Experimental | Drug: RO6889450, Drug: PlaceboParticipants will receive RO6889450 or a dose-matched placebo. NOTE: Part A has completed enrollment. |
| Part B: Add-On Therapy | Experimental | Drug: RO6889450, Drug: PlaceboParticipants will receive a low or high dose of RO6889450 or a dose-matched placebo in addition to their usual anti-psychotic treatment(s). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients with a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI)
- Part B only: Stable treatment with a dopamine/serotonin (D2/5HT2A) antagonist or pure D2 antagonist(s), or a D2 partial agonist for a minimum of 6 months and receiving no more than two antipsychotics
- Medically stable during the 3 months prior to study entry
- Participant is an outpatient with no psychiatric hospitalizations within the prior 6 months
- PANSS negative symptom factor score of 18 or higher
Key exclusion criteria (20 listed)
- Moderate to severe substance use disorder within six months of study entry (excluding nicotine or caffeine) as defined by DSM-5
- Extrapyramidal symptom rating scale (ESRS-A CGI) subscore greater than or equal to 3
- Other current DSM-5 diagnosis (e.g., bipolar disorder, major depressive disorder)
- PANSS item G6 (depression) greater than or equal to 5
- Significant risk of suicide or harming him- or herself or others according to the Investigator's judgment
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 |
|---|---|---|
| RO6889450Participants will receive a once-daily, oral dose of RO6889450 for 12 weeks. | Drug | Part A: Monotherapy, Part B: Add-On Therapy |
| PlaceboParticipants will receive a once-daily, oral dose of placebo matched to RO6889450 for 12 weeks. | Drug | Part A: Monotherapy, Part B: Add-On Therapy |
Primary outcome
Brief Negative Symptoms Scale (BNSS) Avolition/Apathy Subscore and Total Score at Baseline and Week 12
Time frame: Baseline to Week 12
The BNSS is a 13-item instrument designed for clinical trials that measures the severity of the negative symptoms of schizophrenia in five domains. There are 13 items organized into 6 subscales (anhedonia, distress, asociality, avolition, blunted affect, and alogia), each rated on a 7-point scale (0-6) where 0 = absent symptoms and 6 = severe symptoms. The total score is calculated by summing the individual items (13) of each subscale and has a range of 0-78. The avolition/apathy subscale contains 2 items with a total score range of 0-12.
12 secondary outcomes
Clinical Global Impression Severity (CGI-S) Overall Scores
Time frame: Baseline to week 12
CGI-S Negative Symptoms (NS) Scores
Time frame: Baseline to week 12
Clinical Global Impression - Improvement (CGI-I) Overall Scores
Time frame: Up to Week 12 (Day 84)
CGI-I Negative Symptoms Scores
Time frame: Up to Week 12 (Day 84)
Positive and Negative Syndrome Scale (PANSS) Total Scores
Time frame: Baseline to week 12
PANSS Symptom Factor Scores
Time frame: Baseline to week 12
Brief Negative Symptom Scale (BNSS) Total Scores
Time frame: Baseline to week 12
Defeatist Performance Attitude Scale (DPAS) Scores
Time frame: Baseline to week 12
Number of Participants With Suicidal Ideation or Behavior, and Self-injurious Behavior Without Suicidal Intent on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline through Day 84
Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A)
Time frame: Baseline through Day 84
Maximum Serum Concentration (Cmax) of RO6889450
Time frame: Day 42
Area Under the Curve at Steady State (AUCss) of RO6889450
Time frame: Day 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36369028Halff EF, Rutigliano G, Garcia-Hidalgo A, Howes OD. Trace amine-associated receptor 1 (TAAR1) agonism as a new treatment strategy for schizophrenia and related disorders. Trends Neurosci. 2023 Jan;46(1):60-74. doi: 10.1016/j.tins.2022.10.010. Epub 2022 Nov 8.
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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.
Clinical Trials study director
Hoffmann-La Roche
45 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO6889450 in people with Schizophrenia, Schizoaffective Disorder, run by Hoffmann-La Roche at 45 sites in 4 countries.
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 9 inclusion and 20 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: stopped early, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Ukraine, Japan, Spain. 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. 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?
Yes. Results are posted in the registry (first posted 12 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Brief Negative Symptoms Scale (BNSS) Avolition/Apathy Subscore and Total Score at Baseline and Week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03669640, which also lists 1 linked publication.
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 12 Aug 2024.