A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics

Phase 2 Completed 214 enrolled Hoffmann-La Roche

RandomizedParallel-groupDouble-blindTreatment

Summary

This multicenter study assessed the effects of 24 weeks of basmisanil treatment on cognition and functioning of stable schizophrenia participants treated with antipsychotics.

Timeline

Start: 2016-11-30
Primary completion: 2019-12-12
Completion: 2019-12-12

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Basmisanil 240mg BID; p = 0.793; Treatment Difference 0.28 (90% CI -1.47 to 2.02); Mixed Models Analysis NCT02953639 ↗

Publications

Umbricht D, Abt M, Derks M, Hernandez MC, Parkar N, Negron D, Koerner A, Holiga S, Goeldner C. A Phase 2b Multicenter Study to Evaluate Basmisanil as an Adjunctive Treatment in Patients With Cognitive Impairment Associated With Schizophrenia. J Clin Psychiatry. 2026 Apr 15;87(2):25m16022. doi: 10.4088/JCP.25m16022.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Basmisanil	Small molecule	80 mg	Oral
Subject	Basmisanil	Small molecule	240 mg	Oral