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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00057551 |
Purpose
This 24-week study, with a 12-month follow up period, will compare the effectiveness of antidepressant medication alone to the combination of psychotherapy and antidepressant medication in patients with chronic depression.
| Condition | Intervention |
|---|---|
|
Depression Depressive Disorder |
Behavioral: Supportive Therapy Behavioral: Cognitive Behavioral Analysis System of Psychotherapy Drug: Sertraline Drug: Escitalopram Drug: Bupropion SR or XL Drug: Venlafaxine XR Drug: Mirtazapine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | CBASP Augmentation for Treatment of Chronic Depression |
| Estimated Enrollment: | 909 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | March 2006 |
Chronic depression affects approximately 5% of adults in the United States and is associated with significant functional impairment and high health care utilization. The combination of drug treatment and psychotherapy may be most effective in treating depression. This study will determine the effects of adjunctive psychotherapy in depressed patients who have failed to respond or have responded only partially to an initial trial medication.
Participants receive an initial trial of antidepressant medication for 8 to 12 weeks. Participants who continue to have depressive symptoms are randomly assigned to add Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or supportive therapy to their medication regimens or to continue pharmacotherapy alone for an additional 12 weeks. Assessments are made at 6 and 12 months post-treatment.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| United States, Arizona | |
| University of Arizona | |
| Tucson, Arizona, United States, 85724-5002 | |
| United States, California | |
| Stanford University | |
| Palo Alto, California, United States, 94305 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30329 | |
| United States, New York | |
| Weill-Cornell Medical College Payne Whitney Clinic | |
| New York, New York, United States, 10021 | |
| SUNY- Stony Brook | |
| New York, New York, United States, 11794 | |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213-2600 | |
| United States, Rhode Island | |
| Brown University | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75235 | |
| Investigator: | James P. McCullough, Ph.D. | Virginia Commonwealth University |
More Information
| Study ID Numbers: | U01 MH62475, DSIR 83-ATSO, U01 MH61504, U01 MH61562, U01 MH61587, U01 MH61590, U01 MH62465, U01 MH62491, U01 MH62546, U01 MH63481 |
| Study First Received: | April 4, 2003 |
| Last Updated: | June 16, 2006 |
| ClinicalTrials.gov Identifier: | NCT00057551 History of Changes |
| Health Authority: | United States: Federal Government |
|
Neurotransmitter Agents Adrenergic Agents Psychotropic Drugs Mirtazapine Mental Disorders Venlafaxine Sertraline Antidepressive Agents, Second-Generation Dexetimide Antidepressive Agents Depression Adrenergic alpha-Antagonists Depressive Disorder |
Citalopram Serotonin Uptake Inhibitors Serotonin Behavioral Symptoms Antidepressive Agents, Tricyclic Histamine Histamine Antagonists Bupropion Mood Disorders Histamine H1 Antagonists Histamine phosphate Adrenergic Antagonists |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Mirtazapine Mental Disorders Therapeutic Uses Venlafaxine Sertraline Antidepressive Agents, Second-Generation Antidepressive Agents Depression |
Histamine Agents Adrenergic alpha-Antagonists Depressive Disorder Citalopram Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms Antidepressive Agents, Tricyclic Serotonin Agents Histamine Antagonists Mood Disorders Histamine H1 Antagonists Adrenergic Antagonists Central Nervous System Agents |
