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RECRUITING
NCT07565428
PHASE3

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

Sponsor: Minerva Neurosciences

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

380

Start Date

2026-04

Completion Date

2028-12

Last Updated

2026-05-04

Healthy Volunteers

No

Interventions

DRUG

Roluperidone

Roluperidone 64 mg

DRUG

risperidone

risperidone 4 mg

DRUG

aripiprazole

aripiprazole 10 mg

DRUG

olanzapine

olanzapine 10 mg

DRUG

Placebo

Placebo

Locations (2)

CBH Health, LLC dba CenExel

Gaithersburg, Maryland, United States

Hassman Research Institute, LLC dba CenExel

Marlton, New Jersey, United States