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

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT02953639

Run by

Hoffmann-La Roche

People needed

214

Starts

2016-11-30

Expected to finish

2019-12-12

Last updated by the study team

2021-02-09

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Woodland International Research Group Inc. — Little Rock, Arkansas, United States
• Woodland Research Northwest, LLC — Rogers, Arkansas, United States
• ProScience Research Group — Culver City, California, United States
• Collaborative Neuroscience Network, Inc. — Garden Grove, California, United States
• California Clinical Trials — Glendale, California, United States
• Alliance for Wellness, dba Alliance for Research — Long Beach, California, United States
• Synergy Clinical Research — National City, California, United States
• Pacific Research Partners, LLC — Oakland, California, United States
• NRC Research Institute — Orange, California, United States
• CNRI - Los Angeles, LLC — Pico Rivera, California, United States
• Artemis Institute for Clinical Research, LLC — San Diego, California, United States
• Collaborative Neuroscience Network Inc. — Torrance, California, United States
• Yale School of Medicine - CT Mental Health Center (CMHC) - Schizophrenia Research Clinic — New Haven, Connecticut, United States
• Vantage Clinical Trials — Largo, Florida, United States
• Innovative Clinical Research, Inc. — Lauderhill, Florida, United States
• Meridien Research — Maitland, Florida, United States
• University of Miami Dept of Psychiatry — Miami, Florida, United States
• Behavioral Clinical Research, Inc. — North Miami, Florida, United States
• iResearch Atlanta — Decatur, Georgia, United States
• Alexian Brothers Center for Psychiatric Research — Hoffman Estates, Illinois, United States
• Community Clinical Research Center — Anderson, Indiana, United States
• Booker, J. Gary, MD, APMC — Shreveport, Louisiana, United States
• Louisiana Clinical Research, LLC — Shreveport, Louisiana, United States
• CBH Health — Gaithersburg, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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