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Clinical Trials in the EU / 2026-525925-19-00
Authorised, recruiting Phase III

A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Study to Evaluate Efficacy of Roluperidone on Negative Symptoms in Adult Subjects with Schizophrenia, Followed by a 40-Week, Randomized, Double-Dummy Phase to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications

2026-525925-19-00 · tracked via the Priya Life Science EU tracker
Sponsor
Minerva Neurosciences Inc
Sponsor type
Pharmaceutical company
Therapeutic area
Mental Disorders
Decision date
10/08/2026
Enrollment target
120
Sites
Bulgaria, Romania

Condition studied

Schizophrenia with negative symptoms

Investigational medicinal product(s)

OLANZAPINERISPERIDONEPlacebo for over-encapsulated comparatorsARIPIPRAZOLERoluperidonePlacebo for Roluperidone

Eligibility

Age group
18-64 years
Sex
Female, Male

Primary endpoint

Change from Baseline in NSFS

Endpoint detail

Change from Baseline in the PSP Total score, Change from Baseline in the CGI-S score

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2026-525925-19-00 on CTIS ↗ ← All trials in the EU