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| Sponsor: | Research Foundation for Mental Hygiene |
|---|---|
| Collaborators: |
Bronx VA Medical Center Mount Sinai School of Medicine |
| Information provided by: | Research Foundation for Mental Hygiene |
| ClinicalTrials.gov Identifier: | NCT00469664 |
Purpose
Our overall aim is to determine if the administration of guanfacine in combination with aripiprazole, olanzapine, quetiapine, and/or risperidone is significantly more effective than any of those medications alone in treating some of the cognitive impairment in schizophrenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder Cognitive Impairment |
Drug: Guanfacine/Tenex |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Double Blind Placebo Controlled Study of Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia |
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2000 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
The proposed study is a double blind, placebo controlled, parallel designed investigation comparing the effect of one of four atypical antipsychotics (aripiprazole, olanzapine, quetiapine, and/or risperidone), treatment alone to treatment with one of these in addition to treatment with guanfacine to maximum dose of 3.0 mg per day on a cognitive task performance in schizophrenic patients. The study will take place over fourteen weeks. Patients will receive study medication for the last ten weeks of the protocol.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Bronx VA Medical Center | |
| Bronx, New York, United States, 10468 | |
| Mount Sinai Medical Center | |
| NY, New York, United States, 10029 | |
| Pilgrim Psychiatric Center | |
| W. Brentwood, New York, United States, 11717 | |
| Principal Investigator: | Joseph I Friedman, MD | Pilgrim Psychiatric Center, Mount Sinai Medical Center, Bronx VA Medical Center |
More Information
| Responsible Party: | Joseph Friedman, MD, PilgrimPsychiatric Center |
| ClinicalTrials.gov Identifier: | NCT00469664 History of Changes |
| Other Study ID Numbers: | 00110, 99-621 |
| Study First Received: | May 2, 2007 |
| Last Updated: | May 20, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Schizophrenia Schizoaffective Cognitive Impairment Cognition |
Memory Attention Concentration |
|
Psychotic Disorders Schizophrenia Cognition Disorders Schizophrenia and Disorders with Psychotic Features Mental Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Antipsychotic Agents Guanfacine Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Antihypertensive Agents Cardiovascular Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |