Clinical Trial: Wellbutrin XL for Dysthymic Disorder
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: St. Luke's-Roosevelt Hospital Center
Current Primary Outcome: Hamilton Depression Rating Scale, 24 Items (HDRS) [ Time Frame: 10 weeks ]
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)
Original Primary Outcome: Hamilton Depression Rating Scale, 24 Items (HDRS)
Current Secondary Outcome:
- Cornell Dysthymia Rating Scale (CDRS) [ Time Frame: 10 weeks ]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 ]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 ]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 ]A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)
Original Secondary Outcome:
- Cornell Dysthymia Rating Scale (CDRS)
- Beck Depression Inventory (BDI)
- Clinical Global Impressions (CGI)
- Global Assessment of Functioning Scale (GAFS)
- Patient-CGI (CGI-P)
- Social Adjustment Scale (SAS)
- Symptom Checklist (SCL-90-R)
- Temperament and Character Inventory (TCI)
- Medical Outcomes Study- HIV – Cognitive Scale (MOS-HIVcs)
- Aldenkamp-Baker Neurotoxicity Scale (ABS)
- Arizona Sexual Experiences Scale (ASEX)
Information By: St. Luke's-Roosevelt Hospital Center
Dates:
Date Received: September 21, 2005
Date Started: November 2004
Date Completion:
Last Updated: October 29, 2015
Last Verified: October 2014