A Study to Evaluate the Effects of Once Daily Doses of AQW051 on Cognition, in Stable Schizophrenia Patients
NCT ID: NCT01730768
Last Updated: 2020-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
147 participants
INTERVENTIONAL
2012-09-30
2013-12-31
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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AQW051 10 mg/day
Two 5mg AQW051 capsules will be taken orally daily by patients from Day 1 until Day 84.
AQW051
Placebo to AQW051
Matching placebo administered orally.
Placebo
Interventions
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AQW051
Placebo
Eligibility Criteria
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Inclusion Criteria
* Symptomatically stable and currently treated with a stable regimen for at least 3 (three) months prior to dosing with one of the following second generation of antipsychotics: risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole.
* Specific cognitive impairment
* Smokers and non-smokers
Exclusion Criteria
* Current treatment with conventional antipsychotics (e.g fluphenazine, haloperidol) or clozapine.
* History of neuroleptic malignant syndrome.
* Diagnosis of substance abuse (other than nicotine) within the last month and alcohol or substance dependence (other than nicotine) within the last 6 months.
* Score 4 or 5 on the Suicidal Ideation item or any "yes" on the Suicidal Behavior item of the CSSR-S that is related to suicidal behavior occurring during the last 2 years
18 Years
55 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Garden Grove, California, United States
Novartis Investigative Site
Glendale, California, United States
Novartis Investigative Site
National City, California, United States
Novartis Investigative Site
Oakland, California, United States
Novartis Investigative Site
Pico Rivera, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
Miramar, Florida, United States
Novartis Investigative Site
Atlanta, Georgia, United States
Novartis Investigative Site
Marlton, New Jersey, United States
Novartis Investigative Site
Staten Island, New York, United States
Novartis Investigative Site
Staten Island, New York, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Irving, Texas, United States
Countries
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Related Links
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Results for CAQW051A2207 from the Novartis Clinical Trials website
Other Identifiers
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CAQW051A2207
Identifier Type: -
Identifier Source: org_study_id
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