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



Status:Recruiting
Conditions:Cognitive Studies, Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 50
Updated:3/15/2019
Start Date:November 30, 2016
End Date:December 26, 2019
Contact:Reference Study ID Number: BP39207 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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A Phase IIb, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Basmisanil (RO5186582) as Adjunctive Treatment in Patients With Cognitive Impairment Associated With Schizophrenia Treated With Antipsychotics

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


Inclusion Criteria:

- Diagnosis of schizophrenia of any type utilizing the Mini International
Neuropsychiatric Interview and diagnostic and statistical manual of mental disorders,
fifth edition (DSM-5) direct clinical assessments, family informants and past medical
records

- Evidence of stability of symptoms for 3 months at screening, that is, without
hospitalizations for schizophrenia or increase in level of psychiatric care due to
worsening of symptoms of schizophrenia

- Participants with schizophrenia clinical symptom severity defined by the following:
hallucinatory behavior item score less than or equal to ( score
- Participants on a stable regimen of antipsychotic therapy for at least 3 months at
screening and receiving no more than two antipsychotics

Exclusion Criteria:

- Participants with current DSM-5 diagnosis other than schizophrenia including bipolar
disorder, schizoaffective disorder and major depressive disorder

- Clinically significant neurological illness or significant head trauma that affects
cognitive function, in the judgment of the principal investigator

- Full scale intelligence quotient Intelligence at screening

- Positive result at screening for hepatitis B, hepatitis C, or human immunodeficiency
virus-1 and 2

- Moderate to severe substance use disorder (other than nicotine or caffeine), as
defined by the DSM-5, within the last 12 months

- Suicide attempt within 1 year or currently at risk of suicide in the opinion of the
Investigator
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