NCT07565428Phase 3Recruiting

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-12Estimated

Enrollment · participants380Estimated

Source updated2026-07-28Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Negative Symptoms of Schizophrenia

Treatments or interventions studied

RoluperidoneDrugAlso known as MIN-101
risperidoneDrug
aripiprazoleDrug
olanzapineDrug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Change from Baseline to Week 12 in Marder Negative Symptoms Factor Score (NSFS); description: 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.; timeFrame: Phase A: Screening, Baseline, Weeks 2, 4, 8, 12

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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