Schizophrenia Disorders Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Cross-over, Single-dose Study to Evaluate the Effects of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia Including a One Week Multiple-dose Extension to Assess the Persistence of Observed Effects and a Multiple-dose Cross Over Study in Non Smokers Only.
| Verified date | March 2013 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This PoC study is designed to assess the cognitive effects of doses of AQW051 in patients with chronic stable schizophrenia.
| Status | Completed |
| Enrollment | 57 |
| Est. completion date | September 2011 |
| Est. primary completion date | September 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | Inclusion Criteria: 1. Diagnosis of schizophrenia 2. 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. 3. Specific cognitive impairment 4. Smokers and non-smokers Exclusion Criteria: 1. 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. 2. Current treatment with conventional antipsychotics (e.g fluphenazine, haloperidol) or clozapine. 3. History of neuroleptic malignant syndrome. 4. Diagnosis of substance abuse (other than nicotine) within the last month and alcohol or substance dependence (other than nicotine) within the last 6 months. 5. 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests | 132 days Part A, 121 days Part B (screening to study completion) | ||
| Secondary | Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected MATRICS Consensus Cognitive Battery (MCCB) tests | 132 days Part A, 121 days Part B (screening to study completion) | ||
| Secondary | Effects of multiple oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests and selected MCCB tests | 132 days Part A, 121 days Part B (screening to study completion) | ||
| Secondary | Correlation of the cognitive domains measured by MCCB versus CogState | 132 days Part A, 121 days Part B (screening to study completion) | ||
| Secondary | Pharmacokinetics, safety and tolerability of single and multiple doses of AQW051 as compared to placebo | 132 days Part A, 121 days Part B (screening to study completion) |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00119574 -
Evaluating a Collaborative Care Model for the Treatment of Schizophrenia (EQUIP)
|
N/A |