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

  • Schizophrenia
Trial Status:

Completed

This trial runs in
Countries
  • United States
Trial Identifier:

NCT02953639 BP39207

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

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

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT02953639 , BP39207 Trial Identifier
      Basmisanil, Placebo Treatments
      Schizophrenia Condition
      Official Title

      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

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 50 Years Age
      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

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