CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 18 enrolled
Drug / intervention
bupropion XL +1 moredrug
Likely dose
Bupropion XL at an unspecified dose (exact dose not provided in interventions or arms)AI-extracted
Key inclusion· 3
  • ✓Age 18–65 years
  • ✓DSM-IV diagnosis of early-onset dysthymic disorder
  • ✓Hamilton Depression Scale (24-item) score ≥12 at baseline
Key exclusion· 7
  • ✕Major Depressive Disorder, Bipolar Disorder, cyclothymia, Schizophrenia, Delusional Disorder, or other Psychotic Disorders
  • ✕History of or current Anorexia Nervosa or Bulimia
  • ✕Substance abuse or dependence within past 6 months
  • ✕Suicide risk: specific plan, Hamilton item #3 ≥3, or attempt within past 12 months requiring emergency care or hospitalization

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00225251
NCT00225251Phase 4Completed
CompareCT.gov

Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL

St. Luke's-Roosevelt Hospital Center·interventional·Posted Sep 23, 2005·Updated Nov 26, 2015

In Brief

A Phase 4 clinical trial evaluating bupropion XL and Placebo for Dysthymic Disorder. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDysthymic Disorder
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 23, 2005
Enrollment StartNov 1, 2004
Primary CompletionMay 1, 2008
Study CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.8 years ago

Interventions

bupropion XLdrug

Antidepressant medication

Placeboother

Placebo