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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
Antidepressant medication
Placebo
Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center
New York, New York, United States
Hamilton Depression Rating Scale, 24 Items (HDRS)
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)
Time frame: 10 weeks
Cornell Dysthymia Rating Scale (CDRS)
A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression
Time frame: 10 weeks
Beck Depression Inventory (BDI)
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.
Time frame: 10 weeks
Clinical Global Improvement (CGI)
A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)
Time frame: 10 weeks
Global Assessment of Functioning Scale (GAFS)
A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)
Time frame: 10 weeks
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