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
← catalyst calendarNCT07565428 · readout ≤ 499 d
Sponsored by Minerva Neurosciences (industry) · NERV — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
380estimated
Sites
13
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-04-23 | actual | When the study began enrolling |
| Primary completion | Dec 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2026-05-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-28 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Negative Symptoms of Schizophrenia
Interventions
- Drug: Roluperidone — also filed as MIN-101
- Drug: risperidone
- Drug: aripiprazole
- Drug: olanzapine
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFChange from Baseline to Week 12 in Marder Negative Symptoms Factor Score (NSFS)
measured Phase A: Screening, Baseline, Weeks 2, 4, 8, 12
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