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Negative Symptoms of SchizophreniaPhase 3NCT03397134

Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia

A Phase 3 study testing Roluperidone 32 mg and Roluperidone 64 mg in people with Negative Symptoms of Schizophrenia, run by Minerva Neurosciences at 39 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

MIN-101C07 is a multicenter, multinational, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of roluperidone in adult schizophrenia patients.The primary objective is to evaluate the efficacy of 2 fixed doses of roluperidone compared to placebo in improving the… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Negative Symptoms of Schizophrenia
What is being tested?
Roluperidone 32 mg and Roluperidone 64 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
515 participants
Where
39 sitesin 4 countries
Study dates
15 Dec 2017to 15 Feb 2021
Phase
Phase 3
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

  • Patient and patient's legal representative, if applicable, provided informed consent prior to the initiation of any study related procedures, and the patient is judged by the investigator as being capable of understanding the study requirements.
  • Male or female patient, 18 to 55 years of age, inclusive, and body mass index (BMI) < 35 kg/m(2) at Screening.
  • Patient meets the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), as established by a full psychiatric interview in conjunction with the Mini International Neuropsychiatric Interview.
  • Has a reliable caregiver or family member or health care personnel who can provide information towards assessment and support the patient in terms of compliance with the protocol. The caregiver must have contacts with the patient daily for at least 1 hour each time and is not expected to change during the trial.
  • Documented diagnosis of schizophrenia for at least 1 year before screening into the trial.
  • Patient is stable in terms of positive and negative symptoms of schizophrenia over the last 6 months according to his or her treating psychiatrist and based on documentation in the clinical chart.
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  • Patient is currently an outpatient and has not been hospitalized for the last 6 months for acute exacerbation or symptoms worsening. Patients hospitalized during the last 6 months for social reasons or are currently hospitalized for social reasons can be included only with Sponsor's Responsible Medical Officer's approval, and the social reasons must be documented in the electronic case report form (eCRF).
  • Patient with a score of > 20 on the PANSS negative subscore (the original PANSS scale [ Sum of N1+N2+N3+N4+N5+N6+N7]) at Screening (Visit 1) and Baseline (Visit 3) AND < 4 points absolute difference between 2 visits.
  • Patients can be on any psychotropic before the trial if the psychotropics can be discontinued at the beginning of the washout phase without risking the patient's clinical status or safety.
  • No history of violence against self or others during the last 1 year.
  • Female patient who are not of childbearing potential, defined as women who are postmenopausal (defined as spontaneous amenorrhoea for at least 1 year or spontaneous amenorrhoea for at least 6 months confirmed by follicle stimulating hormone result of ≥ 40 IU/mL) or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy).
  • Female patient, if of childbearing potential, must test negative for pregnancy and must be using a double barrier contraceptive method.
  • Patient must be extensive metabolizers for cytochrome P450 (CYP2D6), defined as a subject that has at least one functional allel (e.g., *1 or *2), as determined by study-specific genotyping test before the first drug dose is administered.
  • Patient and the caregiver are considered by the investigator to be reliable and likely to cooperate with the assessment procedures.

Who cannot join

  • Current major depressive disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, or intellectual disability (intellectual developmental disorder diagnosed by age 14).
  • Patient with PANSS item score of > 4 on: P4 excitement/hyperactivity, P6 suspiciousness/persecution, P7 hostility, G8 uncooperativeness, G14 poor impulse control.
  • A Calgary Depression Scale for Schizophrenia (CDSS) total score > 6.
  • A score of ≥ 2 on any 2 items 1, 2, or 3, or a score of ≥ 3 on item 4 of the Barnes Akathisia Rating Scale (BARS).
  • Patient's condition is due to direct psychological effects of a substance (e.g., a drug of abuse, or medication) or a general medical condition.
  • Has a current or recent history of serious suicidal behavior within the past 1 year.
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  • Patient has a history of substance use disorder within 3 months of the Screening visit (excluding caffeine and cigarette smoking).
  • Positive urine drug screen for drugs of abuse (cocaine, methadone, amphetamines, cannabinoids, opiates, benzodiazepines, and barbiturates), tricyclic antidepressants (TCA), and alcohol (except for prescription benzodiazepines).
  • Patient who cannot be discontinued from psychotropics other than those allowed.
  • Patient who received clozapine within 6 months of the Screening visit.
  • Patient receiving treatment with long-acting or depot antipsychotic medication unless his/her next scheduled dose will occur during the protocol Screening period and can be omitted to allow for sufficient washout before receiving the study drug.
  • Patient with a history of significant other major or unstable neurological, neurosurgical (e.g., head trauma), metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder.
  • Patient with a history of seizures (patient with a history of a single childhood febrile seizure may be enrolled in this study).
  • Patient who has had electroconvulsive therapy (ECT), vagal nerve stimulation (VNS), or repetitive trans-cranial magnetic stimulation (r-TMS) within the 6 months prior to the Screening visit or who are scheduled for ECT, VNS, or r-TMS at any time during the study.
  • Patient with clinically significant abnormalities in hematology, blood chemistry, ECG, or physical examination not resolved by the Baseline visit which according to Investigator can interfere with study participation.
  • Current systemic infection (e.g., Hepatitis B, Hepatitis C, human immunodeficiency virus [HIV], tuberculosis). Patients with positive Hepatitis B core antibody test and negative Hepatitis B surface Antigen (HBsAg) may be included in the study if aminotransferase levels (alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT) [ALT/SGPT] and aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) [AST/SGOT] do not exceed 2 times upper limit of normal (ULN).
  • Patient who requires or may require concomitant treatment with any other medication likely to increase QT interval (e.g., paroxetine, fluoxetine, duloxetine, amiodarone).
  • Patient who requires medication inhibiting CYP 2D6 or CYP 3A4.
  • Patient with a clinically significant ECG abnormality that could be a safety issue in the study, including QT interval value corrected for heart rate using the Fridericia's formula (QTcF) > 430 msec for males and > 450 msec for females.
  • Patient with a history of myocardial infarction based on medical history or ECG findings at Screening.
  • Familial or personal history of long QT syndrome or with additional risk factors for Torsade de Pointes.
  • Subjects whose safety laboratory results show hypokalemia, hypomagnesemia, hypocalcemia.
  • Patients with unexplained syncope.
  • Woman of child-bearing potential, or man, who are unwilling or unable to use accepted methods of birth control.
  • Woman with a positive pregnancy test, is lactating, or is planning to become pregnant during the study.
  • Patient who participated in another clinical study within 3 months prior to Screening, or received roluperidone previously, or has previously participated in > 2 clinical studies with experimental medication (previous participation in 3 clinical studies with experimental medication will require approval of the sponsor before eligibility is determined).

Trial locations and contacts

39 sites in 4 countries.

39 sites in 4 countries

Ukraine16 sites

  • Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov," Regional Centre for Psychosomatic Disorders based on Psychoneurological Department

    Dnipro

  • Ivano-Frankivsk National Medical University (IFNMU) - Regional Psycho-Neurological Hospital #3

    Ivano-Frankivsk

  • Kharkiv Railway Clinical Hospital N°1 of Branche "Health Center" of the Public joint stock company "Ukrainian Railway," Psychiatry Department

    Kharkiv

  • State Institution "Institute of Neurology, Psychiatry and Narcology of National Academy of Medical Science of Ukraine," Department of Emergency Psychiatry and Narcology

    Kharkiv

  • State Institution "Institute of Neurology, Psychiatry and Narcology of National Academy of Medical Science of Ukraine," Department of Neuroses and Borderline Conditions

    Kharkiv

  • State Institution "Institute of Neurology, Psychiatry and Narcology of National Academy of Medical Sciences of Ukraine," Department of Clinical, Social and Child Psychiatry

    Kharkiv

  • Kyiv Regional Medical Incorporation "Psychiatry," Centre of Novel Treatment and Rehabilitation of Psychotic Disorders based on Department #29 and Department #30

    Kyiv

  • Communal Institution of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital," Department #20

    Lviv

  • Communal Institution of Lviv Regional Council "Lviv Regional Clinical Psychiatry Hospital," General Psychiatric Mixed Department #25

    Lviv

  • Odessa Regional Medical Centre of Mental Health, Dept. #6 (male), Dept. #12 (female)

    Odesa

  • Kyiv Regional Medical Incorporation "Psychiatry," Centre of Novel Treatment and Rehabilitation of Psychotic Disorders based on Department #29 and Department #30

    Oleksandrivka

  • "Ukrainian medical stomatological academy," Chair of psychiatry, narcology and medical psychology based on Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev, female acute general psych. dept. 5-b, male acute general psych. dept 2-a

    Poltava

  • Communal Institution "Cherkasy Regional Psychiatric Hospital"

    Smila

  • Municipal Institution Kherson Regional Psychiatric Hospital of Regional Council

    Stepanovka

  • Ternopil Regional Municipal Clinical Psychoneurological Hospital

    Ternopil

  • Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko," Male Department No 14, Female Department No 15

    Vinnytsia

Other trials in Ukraine

United States13 sites

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • Hassman Research Institute, LLC.

    Berlin, New Jersey, 08009

  • Uptown Research Institute LLC

    Chicago, Illinois, 60640

  • ProScience Research Group

    Culver City, California, 90230

  • InSite Clinical Research LLC

    DeSoto, Texas, 75115

  • Collaborative Neuroscience Network, LLC.

    Garden Grove, California, 92845

  • Synergy Clinical Center

    National City, California, 91950

  • Behavioral Clinical Research, Inc

    North Miami, Florida, 33161

  • Research Centers of America, LLC

    Oakland Park, Florida, 33334

  • The Nathan Kline Institute for Psychiatric Research

    Orangeburg, New York, 10962

  • Pillar Clinical Research LLC

    Richardson, Texas, 75080

  • Woodland Research Northwest

    Rogers, Arkansas, 72758

  • Collaborative Neuroscience Network, LLC.

    Torrance, California, 90502

Other trials in United States

Bulgaria7 sites

  • "Mental Health Center Prof. Dr. Ivan Temkov - Burgas" EOOD Department For Treatment of Emergency Psychiatry Conditions

    Burgas

  • State Psychiatry Hospital - Lovech

    Lovech

  • State Psychiatry Hospital "Sveti Ivan Rilski" Department of General Psychiatry for adults "closed type" - males; Department of General Psychiatry for adults "closed type" - females

    Novi Iskar

  • 'Mental Health Center Plovdiv"-EOOD Department for treatment of acute female/male psychoses with endogenous, exogenous, organic psychotic disturbances of the personality

    Plovdiv

  • Multiprofile Hospital for Active Treatment - Targovishte" AD Department of Psychiatry

    Targovishte

  • "State Psychiatric Hospital - Tserova Koria"; Department for Active Treatment of Severe Psychosis - male; Department for Active Treatment of Severe Psychosis - male

    Tserova Koria, Veliko Tarnovo District

  • "Mental Health Center - Vratsa" General Psychiatric Department

    Vratsa

Other trials in Bulgaria

Poland3 sites

  • Samodzielny Publiczny Psychiatryczny zakład opieki zdrowotnej im Dr. Stanisława Deresza w Choroszczy

    Choroszcz

  • Medical University of Gdańsk, Department of Psychiatry UCK

    Gdansk

  • Klinika Psychiatryczna Inventiva

    Tuszyn

Other trials in Poland

About this study

Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, 12-Week Study to Evaluate the Efficacy and Safety of 2 Fixed Doses of MIN-101 in Adult Patients With Negative Symptoms of Schizophrenia, Followed by a 40-Week Open-Label Extension

MIN-101C07 is a multicenter, multinational, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of roluperidone in adult schizophrenia patients.The primary objective is to evaluate the efficacy of 2 fixed doses of roluperidone compared to placebo in improving the negative symptoms of schizophrenia over 12 weeks of double-blind treatment as measured by the change in Positive and Negative Syndrome Scale (PANSS) Marder negative symptoms factor score (NSFS) over 12 weeks.

Being tested
Placebo Oral Tablet, Roluperidone 32 mg, Roluperidone 64 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo Oral TabletDrug

    Placebo administered as a single dose once daily

  • Roluperidone 32 mgDrug

    Roluperidone administered as a single dose once daily

  • Roluperidone 64 mgDrug

    Roluperidone administered as a single dose once daily

Study groups in NCT03397134
Study groupRoleWhat they receive
Roluperidone 64 mgExperimentalRoluperidone 64 mg for entire study
Receives: Drug: Roluperidone 64 mg
Roluperidone 32 mgExperimentalRoluperidone mg for entire study
Receives: Drug: Roluperidone 32 mg
Placebo-1Placebo comparatorPlacebo for 12 weeks followed by Roluperidone 64 mg during open-label extension
Receives: Drug: Placebo Oral Tablet; Drug: Roluperidone 64 mg
Placebo-2Placebo comparatorPlacebo for 12 weeks followed by Roluperidone 32 mg during open-label extension
Receives: Drug: Placebo Oral Tablet; Drug: Roluperidone 32 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 12 in PANSS Marder Negative Symptoms Factor Score (NSFS)

    The Marder negative symptoms factor score (NSFS) derived from the complete Positive and Negative Syndrome Scale (PANSS) has been the most frequently used scale in schizophrenia clinical studies focusing on negative symptoms The PANSS measures comprehensive psychiatric symptoms, including positive, negative, and general symptoms. The full PANSS rates the patient on 30 different symptoms from 1 (absent) to 7 (extreme) based on an interview as well as reports of family members or primary care hospital workers. The NSFS consists of the sum of the negative symptom PANSS items N1, N2, N3, N4, N6, G7, and G16 (minimum score = 7; maximum score = 49). Higher scores indicate more severe symptoms.

    Measured: Baseline, Week 2, Week 4, Week 8, and Week 12

Secondary outcomes (9)

  1. Change From Baseline to Week 12 in Personal and Social Performance (PSP)

    The PSP scale is a validated clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (eg, work and study), personal and social relationships, self care, and disturbing and aggressive behaviors. It is a reliable, quick measure of personal and social functioning of patients with schizophrenia and can be used on patients in the acute and stable stage. PSP is a 100-point scale, divided into 10 equal intervals. The score is based on the assessment of a patient's performance in the 4 domains. Lower scores of 1 to 30 reflected poor functioning that the patient required intensive support or supervision; scores of 31 to 60 reflected varying degrees of disability; and scores of 71 to 100 reflected absence of disability or only mild difficulties.

    Measured: Baseline, Week 4, Week 8, and Week 12

  2. Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)

    The Clinical Global Impression of Severity (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients

    Measured: Baseline, Week 2, Week 4, Week 8, and Week 12

  3. Number of Participants With Potentially Clinically Significant Laboratory Values (Whole Study Period; Safety Population)

    Laboratory abnormalities were determined using pre-defined normal ranges. Clinical laboratory values were considered potentially clinically significant (PCS) for select parameters of hematology, chemistry, and urinalysis. The number and percentage of patients experiencing PCS laboratory abnormalities post-baseline were summarized by treatment group.

    Measured: Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period")

  4. Number of Participants With Potentially Clinically Significant ECG Parameters (Whole Study Period; Safety Population)

    QTcF values were tabulated for their absolute values and tabulated relative to Baseline measurements in order to detect individual QTcF changes. The number and percentage of patients who met criteria for potentially clinically significant (PCS) values were summarized.

    Measured: Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period")

  5. Number of Participants With Potentially Clinically Significant Vital Signs (Whole Study Period; Safety Population)

    The number and percentage of patients with any potentially clinically significant (PCS) vital sign (systolic blood pressure, diastolic blood pressure, heart rate/pulse rate, temperature) occurring post-Baseline were summarized.

    Measured: Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period")

  6. Safety Assessment - Abnormal Involuntary Movement Scale (AIMS)

    AIMS is rating scale that was designed to measure tardive dyskinesia (TD). For the scoring, the AIMS scale has 14 items. The first 10 items (under categories of Facial and Oral Movements, Extremity Movements, Trunk Movements, and Global Judgements) are rated from 0 (none) to 4 (severe); the remaining 4 items (Dental Status) are rated "yes" and "no" and not counted. The analysis is limited to items 1 to 10, with each rated from 0 to 4. The total score is the sum of all 10 items and with values ranging from 0 to 40. For the analysis, the observed composite movement (total) score will be summarized by treatment group and study visit. Higher scores imply worse outcome.

    Measured: Study Baseline Day -1, Active Baseline last assessment on placebo at Week 12, as appropriate, Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 54. Active Baseline=last assessment before receiving Roluperidone.

  7. Safety Assessments - Barnes Akathisia Rations Scale (BARS)

    The BARS is a multiple-choice questionnaire that clinicians used to provide an assessment of akathisia. The BARS scale has 3 items that are rated from 0 (absence/no distress) to 3 (most severe). The BARS rating scale is scored by summing the scales for Objective Akathisia, Subjective Awareness of Restlessness and Subjective Distress Related to Restlessness yielding a total score ranging from 0 to 9. The Total score, which has a possible range from 0-9, is reported. Higher scores imply worse outcome.

    Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, and Week 12

  8. Safety Assessments -Simpson-Angus Scale (S-AS) Score

    The S-AS is an established reliable and valid rating scale that measures drug-induced extrapyramidal syndromes using 10 items rated from 0 = not present to 4 = extremely severe. It consisted of 1 item measuring gait (hypokinesia), 6 items measuring rigidity (arm dropping, shoulder shacking, elbow rigidity, wrist rigidity, leg pendulousness, and head dropping) and 3 items measuring glabella tap, tremor, and salivation. As such, the range of scores was 0 to 40, with increased scores indicating increased severity.

    Measured: Study Baseline Day -1, Active Baseline last assessment on placebo at Week 12, as appropriate, Weeks 13, 14, 15, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 54. Active Baseline=last assessment before receiving Roluperidone.

  9. Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score

    Sheehan Suicidality Tracking Scale (STS) is a prospective rating scale that tracks treatment-emergent suicidal ideation and behaviors.

    Scoring: Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (extremely). Data from the STS can be analyzed as individual item scores, a subscore for suicidal ideation (sum of scores from items 2, 3, and 4, plus score from item 5 if ≤ 1), a subscore for suicidal behavior (sum of scores from items 6, 7, and 8, plus score from item 5 if > 1) and the total scale score (calculated by add scores from Questions 1a (only if 1b is coded YES), + 2 through 11 + [the highest of 12 or any row of 16] + [the highest of 14 or any row of 15] + 17 + 20.

    Analysis: The total scale score will be summarized by treatment group and study visit. Complete data will be presented in patient data listings by treatment group and visit. The total score is the sum of all 16 questions and with values ranging from 0 to 64. Higher scores imply worse outcome.

    Measured: Study Baseline Day -1, Active Baseline last assessment on placebo at Week 12, as appropriate, Weeks 13, 14, 15, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 54. Active Baseline=last assessment before receiving Roluperidone.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2018
  2. Study start15 Dec 2017
  3. Primary completion26 May 2020
  4. Study completion15 Feb 2021

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
515 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03397134
Sponsor's protocol ID
MIN-101C07
Status last verified
Apr 2023
First submitted
29 Dec 2017
Last updated
28 Apr 2023
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Davidson M, Saoud J, Staner C, Noel N, Werner S, Luthringer E, Walling D, Weiser M, Harvey PD, Strauss GP, Luthringer R. Efficacy and Safety of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia. Schizophr Bull. 2022 May 7;48(3):609-619. doi: 10.1093/schbul/sbac013.

    PubMed 35211743

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Roluperidone 32 mg and Roluperidone 64 mg in people with Negative Symptoms of Schizophrenia, run by Minerva Neurosciences at 39 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 14 inclusion and 26 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: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Ukraine, United States, Bulgaria, Poland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 28 Apr 2023). 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?

Change From Baseline to Week 12 in PANSS Marder Negative Symptoms Factor Score (NSFS) (time frame: Baseline, Week 2, Week 4, Week 8, and 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 NCT03397134, 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 28 Apr 2023.

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