A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics
NCT ID: NCT02953639
Last Updated: 2021-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
214 participants
INTERVENTIONAL
2016-11-30
2019-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks.
Placebo
Participants received matching Placebo to Basmisanil, as per the dosing schedules described above.
Basmisanil 80mg BID
Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks.
Basmisanil
Participants received either 80 milligrams (mg) or 240 mg of Basmisanil, as per the dosing schedules described above.
Basmisanil 240mg BID
Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks.
Basmisanil
Participants received either 80 milligrams (mg) or 240 mg of Basmisanil, as per the dosing schedules described above.
Interventions
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Basmisanil
Participants received either 80 milligrams (mg) or 240 mg of Basmisanil, as per the dosing schedules described above.
Placebo
Participants received matching Placebo to Basmisanil, as per the dosing schedules described above.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Arch Clinical Trials, LLC
St Louis, Missouri, United States
St Louis Clinical Trials
St Louis, Missouri, United States
Hassman Research Institute
Berlin, New Jersey, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Manhattan Psychiatric Center; Psychopharmacology Research Unit
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, United States
University Hospitals
Cleveland, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Pillar Clinical Research LLC
Garland, Texas, United States
University Hills Clinical Research - Irving;Office of Dr. Knesevich
Irving, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BP39207
Identifier Type: -
Identifier Source: org_study_id
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