Clinical Trial

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

Recruiting Phase 3
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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.
Protocol Amendment History 2 changes
notable Trial sites expanded: 5 -> 13 locations 2026-07-29
notable Trial sites expanded: 2 -> 5 locations 2026-06-16
Trial Details
NCT Number NCT07565428
Lead Sponsor Minerva Neurosciences
Conditions Negative Symptoms of Schizophrenia
Enrollment 380 participants
Start Date 2026-04-23
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-28