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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 is a Phase 3 study that is actively recruiting participants, run by Minerva Neurosciences. The registered enrollment target is 380 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07565428
The ClinicalTrials.gov registry entry for NCT07565428 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 380 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Minerva Neurosciences, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT07565428 reports 0 study locations.
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.
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