A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics
Recruiting in Palo Alto (17 mi)
+36 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Hoffmann-La Roche
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This multicenter study assessed the effects of 24 weeks of basmisanil treatment on cognition and functioning of stable schizophrenia participants treated with antipsychotics.
Research Team
CT
Clinical Trials
Principal Investigator
Hoffmann-La Roche
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
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Treatment Details
Interventions
- Basmisanil (GABA-A receptor modulator)
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Basmisanil 80mg BIDExperimental Treatment1 Intervention
Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks.
Group II: Basmisanil 240mg BIDExperimental Treatment1 Intervention
Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks.
Group III: PlaceboPlacebo Group1 Intervention
Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks.
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Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University