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

NCT02953639

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Schizophrenia

Interventions: Basmisanil, Placebo

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 50 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 (\</=) 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

Locations (37)

Little Rock, Arkansas, United States
Rogers, Arkansas, United States
Culver City, California, United States
Garden Grove, California, United States
Glendale, California, United States
Long Beach, California, United States
National City, California, United States
Oakland, California, United States
Orange, California, United States
Pico Rivera, California, United States
San Diego, California, United States
Torrance, California, United States
New Haven, Connecticut, United States
Largo, Florida, United States
Lauderhill, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
North Miami, Florida, United States
Decatur, Georgia, United States
Hoffman Estates, Illinois, United States
Anderson, Indiana, United States
Shreveport, Louisiana, United States
Shreveport, Louisiana, United States
Gaithersburg, Maryland, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Berlin, New Jersey, United States
Cedarhurst, New York, United States
New York, New York, United States
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