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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-525925-19-00

Enrollment

120

Registered

2026-08-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia with negative symptoms

Brief summary

Change from Baseline in NSFS

Detailed description

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

Interventions

DRUGOLANZAPINE

DRUGRISPERIDONE

DRUGPlacebo for over-encapsulated comparators

DRUGARIPIPRAZOLE

DRUGRoluperidone

DRUGPlacebo for Roluperidone

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change from Baseline in NSFS	—

Secondary

Measure	Time frame
Change from Baseline in the PSP Total score, Change from Baseline in the CGI-S score	—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 11, 2026