Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia

Negative Symptoms of Schizophrenia Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, 12-Week Study to Evaluate the Efficacy and Safety of 2 Fixed Doses of MIN-101 in Adult Patients With Negative Symptoms of Schizophrenia, Followed by a 40-Week Open-Label Extension

Status Completed

Clinical Trial Summary

MIN-101C07 is a multicenter, multinational, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of roluperidone in adult schizophrenia patients.The primary objective is to evaluate the efficacy of 2 fixed doses of roluperidone compared to placebo in improving the negative symptoms of schizophrenia over 12 weeks of double-blind treatment as measured by the change in Positive and Negative Syndrome Scale (PANSS) Marder negative symptoms factor score (NSFS) over 12 weeks.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Negative Symptoms of Schizophrenia
Schizophrenia

Clinical Trial Details

NCT number	NCT03397134
Study type	Interventional
Source	Minerva Neurosciences
Contact
Status	Completed
Phase	Phase 3
Start date	December 15, 2017
Completion date	February 15, 2021

View Details

See also
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Withdrawn	`NCT01234298` - SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia	Phase 3
Recruiting	`NCT04620460` - Efficacy and Mechanisms of Low-intensity Focused Ultrasound on Negative Symptoms in Patients With Schizophrenia	N/A