Status:
COMPLETED
Effect of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Schizophrenia Disorders
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
This PoC study is designed to assess the cognitive effects of doses of AQW051 in patients with chronic stable schizophrenia.
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia
- 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
- Current treatment with an anticholinergic or other agent known to adversely interfere with the cholinergic system, and/ or treatment with cholinesterase inhibitor within the last three (3) months prior to dosing.
- 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.
- Any clinically significant suicidal ideation (Type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the last month) or previous history of suicide behavior Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01163227
Start Date
May 1 2010
End Date
September 1 2011
Last Update
December 24 2020
Active Locations (2)
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1
PAREXEL (California Clinical Trials Medical Group), 1560 Chevy Chase Drive, Suite 140,
Glendale, California, United States, 91206
2
CRI Worldwide, 1113 Hospital Dr. Suite 202,
Willingboro, New Jersey, United States, 08046