Wellbutrin XL for Dysthymic Disorder
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL|
- Hamilton Depression Rating Scale, 24 Items (HDRS) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
Widely used depression rating scale, with higher scores reflecting greater level of depression. Assesses suicidality which is a safety issue.
This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)
- Cornell Dysthymia Rating Scale (CDRS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression
- Beck Depression Inventory (BDI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.
- Clinical Global Improvement (CGI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)
- Global Assessment of Functioning Scale (GAFS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)
|Study Start Date:||November 2004|
|Study Completion Date:||June 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Experimental: bupropion XL
Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
Drug: bupropion XL
Other Name: Wellbutrin XL
Placebo Comparator: Placebo
Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
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 Diagnostic and Statistical Manual-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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00225251
|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|