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
NCT07565428Phase 3Recruiting
- Lead sponsor
- Minerva Neurosciences (Industry)
- Enrollment
- 380 (estimated)
- Start date
- 23 Apr 2026
- Primary completion
- Dec 2027 (estimated)
- Study completion
- 1 Dec 2028
- Last update posted
- 28 Jul 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Quadruple
- Arms
- 4
Interventions
- Roluperidone Drug
- risperidone Drug
- aripiprazole Drug
- olanzapine Drug
- Placebo Drug
Conditions and primary outcome
- Negative Symptoms of Schizophrenia
Primary outcome
Change from Baseline to Week 12 in Marder Negative Symptoms Factor Score (NSFS) (Phase A: Screening, Baseline, Weeks 2, 4, 8, 12)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT07565428.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT07565428 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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