Effect of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia
Completed · Phase 2 · Has a placebo group
Conditions studied: Schizophrenia Disorders
In brief
This PoC study is designed to assess the cognitive effects of doses of AQW051 in patients with chronic stable schizophrenia.
Key facts
- Study ID
- NCT01163227
- Run by
- Novartis Pharmaceuticals
- People needed
- 57
- Starts
- 2010-05-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2020-12-24
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- PAREXEL (California Clinical Trials Medical Group), 1560 Chevy Chase Drive, Suite 140, — Glendale, California, United States
- CRI Worldwide, 1113 Hospital Dr. Suite 202, — Willingboro, New Jersey, United States
Full record on ClinicalTrials.gov
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