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

NCT02953639 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2021-02-09

Study results available
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Summary

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

Conditions

Interventions

DRUG

Basmisanil

Participants received either 80 milligrams (mg) or 240 mg of Basmisanil, as per the dosing schedules described above.

DRUG

Placebo

Participants received matching Placebo to Basmisanil, as per the dosing schedules described above.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-12-12
Completion
2019-12-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02953639 on ClinicalTrials.gov