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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: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| 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: | PilgrimPsychiatric Center ( Joseph Friedman, MD ) |
| Study ID Numbers: | 00110, 99-621 |
| Study First Received: | May 2, 2007 |
| Last Updated: | May 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00469664 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Schizophrenia Schizoaffective Cognitive Impairment Cognition |
Memory Attention Concentration |
|
Neurotransmitter Agents Adrenergic alpha-Agonists Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Cardiovascular Agents Antihypertensive Agents Antipsychotic Agents |
Adrenergic Agonists Cognition Disorders Pharmacologic Actions Schizophrenia Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Guanfacine Therapeutic Uses Psychotic Disorders Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |