Overview

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

Status:
Completed
Trial end date:
2019-12-12
Target enrollment:
0
Participant gender:
All
Summary
This multicenter study assessed the effects of 24 weeks of basmisanil treatment on cognition and functioning of stable schizophrenia participants treated with antipsychotics.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Antipsychotic Agents
Criteria
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