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NCT07565428 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Minerva Neurosciences.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 380
- Enrollment target
NCT07565428: Recruiting Phase 3 study, sponsored by Minerva Neurosciences.
NCT07565428 is a Phase 3 study that is actively recruiting participants, run by Minerva Neurosciences. The registered enrollment target is 380 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07565428, a Phase 3 study, is actively recruiting participants, sponsored by Minerva Neurosciences.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 380 participants
- Enrollment target
Study Summary
Evaluate the efficacy, as well as safety and pharmacokinetics, of Roluperidone in improving the negative symptoms of schizophrenia in adult subjects in Phase A of study, followed by Phase B of study to evaluate the relapse rate of Roluperidone and antipsychotic medications.
Primary Outcome
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 hosp
Interventions
- DRUG Placebo
- DRUG risperidone
- DRUG olanzapine
- DRUG aripiprazole
- DRUG Roluperidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2026-04-23 |
| Est. Completion | 2028-12 |
| Phase | Phase 3 |
What NCT07565428 shows while recruiting
NCT07565428 is an interventional study that assigns participants to a tested intervention. The registered 380 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT07565428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07565428 about?
NCT07565428 is a clinical study titled "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". Evaluate the efficacy, as well as safety and pharmacokinetics, of Roluperidone in improving the negative symptoms of schizophrenia in adult subjects in Phase A of study, followed by Phase B of study to evaluate the relapse rate of Roluperidone and antipsychotic medications.
What is the current status of trial NCT07565428?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 380 participants. The study started on 2026-04-23. Estimated completion is 2028-12.
What interventions are being tested in trial NCT07565428?
The interventions under investigation include: Placebo (DRUG), risperidone (DRUG), olanzapine (DRUG), aripiprazole (DRUG), Roluperidone (DRUG).
Who is sponsoring clinical trial NCT07565428?
This trial is sponsored by Minerva Neurosciences, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07565428's enrollment target sits among peer trials
380 983rd of 2000 higher than 1,014 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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