An open-label, rater-blinded, 8-week trial of bupropion hydrochloride extended-release in patients with major depressive disorder with atypical features.

Abstract

The present study aimed at investigating the effectiveness and tolerability of -bupropion hydrochloride extended release (XL) in major depressive disorder (MDD) patients with atypical features (AF).51 patients were prescribed bupropion XL for 8 weeks (6 visits: screening, baseline, weeks 1, 2, 4 and 8). The primary efficacy measure was a change of the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD) from baseline to endpoint. Secondary efficacy measures included the SIGH-SAD atypical symptoms subscale, Clinical Global Impression-Severity (CGI-S), Sheehan Disability Scale (SDS) and Epworth Sleepiness Questionnaire (ESQ). Response or remission was defined as ≥50% reduction or ≤7 in SIGH-SAD total scores, respectively, at end of treatment.The HAM-D-29 total score reduced by 55.3% from baseline (27.3±6.5) to end of treatment (12.2±6.3) (p<0.001). Atypical symptom subscale scores also reduced by 54.5% from baseline (9.2±3.0) to end of treatment (4.2±2.8) (p<0.001). At the end of treatment, 24.4% (n=10) and 51.2% (n=21) subjects were classified as remitters and responders, respectively. The most frequently reported AEs were headache (13.7%), dry mouth (11.8%), dizziness (9.8%), and dyspepsia (9.8%).Our preliminary study indicates that bupropion XL may be beneficial in the treatment of MDD with atypical features. Adequately powered, randomized, double-blind, placebo-controlled trials are necessary to determine our results.

• Authors: H-J Seo, B C Lee, J-H Seok, H J Jeon, J-W Paik, W Kim, K-P Kwak, C Han, K-U Lee, C-U Pae
• Journal: Pharmacopsychiatry (Pharmacopsychiatry) Vol. 46 Issue 6 Pg. 221-6 (Sep 2013) ISSN: 1439-0795 [Electronic] Germany
• PMID: 23963965 (Publication Type: Controlled Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © Georg Thieme Verlag KG Stuttgart · New York.

Chemical References

• Antidepressive Agents, Second-Generation
• Delayed-Action Preparations
• Bupropion

Topics

• Adult
• Antidepressive Agents, Second-Generation (administration & dosage, adverse effects, therapeutic use)
• Bupropion (administration & dosage, adverse effects, therapeutic use)
• Delayed-Action Preparations (adverse effects)
• Depressive Disorder, Major (diagnosis, drug therapy)
• Female
• Humans
• Male
• Middle Aged
• Psychiatric Status Rating Scales
• Single-Blind Method