Trial · NCT07565428
Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications
NCT07565428, Phase 3, Recruiting, Minerva Neurosciences
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications. Trials, record NCT07565428. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07565428
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications
- NCT number
- NCT07565428
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 380 participants, estimated
- Lead sponsor
- Minerva Neurosciences
- Conditions
- Negative Symptoms of Schizophrenia
- Interventions
- Roluperidone, risperidone, aripiprazole, olanzapine, Placebo
- First posted
- 2026-05-04
- Last updated
- 2026-07-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline to Week 12 in Marder Negative Symptoms Factor Score (NSFS) | Phase A: Screening, Baseline, Weeks 2, 4, 8, 12 | 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. Negative symptoms will be defined by PANSS negative subscore (N1+N2+N3+N4+N5+N6+N7). Higher scores indicate more severe symptoms. |
| Secondary | Change from Baseline to Week 12 in the Personal and Social Performance (PSP) Total Score | Phase A: Baseline and Weeks 4, 8, 12 | PSP scale=validated clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (eg, work \& study), personal \& social relationships, self-care, \& disturbing and aggressive behaviors. PSP is 100-item scale, divided in 10 similar intervals. Score based on first assessing patient's performance in 4 domains by assigning initial degree of severity (absent, mild, manifest, marked, severe, or very severe) to each domain. Second, a table with levels of score is used, setting correspondent decile (eg, 21-30), according to observed performance across the 4 domains. Third, within selected decile, final value is assigned (eg, within range 21-30, the performance corresponds to score 24). Resulting final value is single measurement from 0-100% of functioning. This single value is PSP total score. Lower scores 1-30=poor functioning; scores 31-60=varying degrees of disability; and scores 71-100=disability absence or only mild difficulties. |
| Secondary | Change from Baseline to Week 12 in Clinical Global Impression - Severity (CGI-S) Scale | Phase A: Screening, Baseline, and Weeks 2, 4, 8, 12 | The CGI-S is a clinician-rated scale that is designed to rate the severity of the patient's illness at the time of assessment, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function relative to the clinician's past experience with patients who have the same diagnosis and improvement with treatment. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating, according to: normal (not at all ill) = 1; borderline mentally ill = 2; mildly ill = 3; moderately ill = 4; markedly ill = 5; severely ill = 6; or extremely ill = 7. |
| Other | Safety Assessments | Phase A: Screening through Week 12; Phase B: Week 12 +1 Day through Week 66 | Adverse Event assessment throughout the study from the time of informed consent form signature to End of Study. |
| Other | Number of Subjects who Relapse over 12 Weeks of Double-blind Treatment (Phase A) and over 52 Weeks of Treatment (Phase B) | Phase A: Day 1 to Week 12; Phase B: Week 12 +1 Day to Week 64 | The number and percentage of subjects who relapse in the roluperidone group versus the placebo group over 12 weeks of double-blind treatment in Phase A of the study and over 52 weeks of treatment in Phase B of the study will be summarized. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07565428
GET https://conductscience.org/api/trials/v1/NCT07565428/registered