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| Sponsor: | St. Luke's-Roosevelt Hospital Center |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | St. Luke's-Roosevelt Hospital Center |
| ClinicalTrials.gov Identifier: | NCT00225251 |
Purpose
This is a ten-week, double-blind study of Wellbutrin XL in outpatients with dysthymic disorder, a form of low-grade chronic depression. We hypothesize that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Dysthymic Disorder |
Drug: bupropion XL |
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: | Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL |
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2004 |
This is a ten-week, double-blind, placebo-controlled study designed to evaluate the tolerability, dosing and efficacy of Wellbutrin XL in outpatients who meet DSM-IV criteria for early onset, primary type dysthymic disorder (low-grade chronic depression). It is hypothesized that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following:
Contacts and Locations| United States, New York | |
| Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center | |
| New York, New York, United States, 10019 | |
| Principal Investigator: | David J. Hellerstein, MD | St. Luke's-Roosevelt Hospital Center, and NY State Psychiatric Institute |
More Information
| ClinicalTrials.gov Identifier: | NCT00225251 History of Changes |
| Other Study ID Numbers: | gsk 102149 |
| Study First Received: | September 21, 2005 |
| Last Updated: | June 5, 2007 |
| Health Authority: | United States: Institutional Review Board |
|
Dysthymic Disorder Dysthymia Depression Chronic Depression Wellbutrin XL |
|
Dysthymic Disorder Depressive Disorder Mood Disorders Mental Disorders Bupropion Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |