A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics
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Lead
Hoffmann-La Roche
Age
18–50
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics
