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

Roche

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Basmisanil; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02953639

BP39207

Details and patient eligibility

About

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

Enrollment: 214 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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 (</=) 5 and a delusion item score </= 5 of the PANSS
• 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 </=65 on the Wechsler Abbreviated Scale of 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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214 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks.

Treatment:

Drug: Placebo

Basmisanil 80mg BID

Experimental group

Description:

Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks.

Treatment:

Drug: Basmisanil

Basmisanil 240mg BID

Experimental group

Description:

Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks.

Treatment:

Drug: Basmisanil