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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by (Responsible Party): | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00825539 |
Purpose
Part 1 of the study will assess the enhancement of task-related brain activation (BOLD response) in key brain areas in schizophrenia during the performance of working memory, episodic memory and visual activation tasks as measured by functional magnetic resonance imaging (fMRI) in people with schizophrenia. Part 2 of the study will assess the safety and tolerability of multiple doses of AQW051 in people with schizophrenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: AQW051 Drug: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Single-dose, Placebo-controlled, Stratified, Randomized, Double-blind, Crossover to Study Pharmacodynamic Effects of AQW051 Followed by a 4-week Multiple-dose Safety and Tolerability in People With Chronic Stable Schizophrenia. |
| Enrollment: | 68 |
| Study Start Date: | January 2009 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo | Drug: Placebo |
| Experimental: AQW051 |
Drug: AQW051
N/A
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects will meet the following symptom criteria:
Subjects will meet the following cognitive performance criteria:
Female subjects of childbearing potential must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the study, through study completion. Pregnancy tests are required of all female subjects regardless of reported sterilization.
When performed at screening and practice visit, the result of this test must be received before the subject may be dosed.
Exclusion criteria:
Subjects with a history of significant head injury/trauma, as defined by:
No grapefruit or grapefruit juice is to be consumed for 14 days prior to dosing until 7 days following the last dose.
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations| United States, California | |
| West LA VA Healthcare Center (UCLA) | |
| Los Angeles, California, United States, 90073 | |
| United States, Illinois | |
| Department of Psychiatry & Behavioural Sciences, Feinberg School of Medicine (Northwestern University) | |
| Chicago, Illinois, United States, 60611 | |
| United States, Maryland | |
| Maryland Psychiatric Research Centre, Spring Grove Hospital Grounds | |
| Baltimore, Maryland, United States, 21228 | |
| United States, Massachusetts | |
| Massachusetts General Hospital (Freedom Trail Clinic) | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Missouri | |
| Washington University | |
| St Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| JUH Clinical Research (Duke University), | |
| Butner, North Carolina, United States, 27509 | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00825539 History of Changes |
| Other Study ID Numbers: | CAQW051A2202 |
| Study First Received: | January 19, 2009 |
| Last Updated: | April 24, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Schizophrenia Manic depression anxiety |
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |