PMID- 16848645 OWN - NLM STAT- MEDLINE DCOM- 20070827 LR - 20190902 IS - 1555-2101 (Electronic) IS - 0160-6689 (Linking) VI - 67 IP - 6 DP - 2006 Jun TI - Extended-release bupropion for patients with major depressive disorder presenting with symptoms of reduced energy, pleasure, and interest: findings from a randomized, double-blind, placebo-controlled study. PG - 865-73 AB - OBJECTIVE: This multicenter, double-blind, placebo-controlled study evaluated the efficacy and safety of extended-release bupropion (bupropion XL) in the treatment of major depressive disorder (MDD) with prominent symptoms of decreased energy, pleasure, and interest. METHOD: Eligible adult outpatients meeting DSM-IV criteria for MDD were randomly assigned to bupropion XL 300 to 450 mg/day (N = 135) or placebo (N = 139) for 8 weeks. The primary efficacy measure, change from baseline on the 30-item Inventory of Depressive Symptomatology-Self Report (IDS-IVR-30) total score, was obtained using interactive voice response (IVR) technology. Secondary measures included change from baseline on the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C-30) total score and change in domain subset scores for energy, pleasure, and interest; for insomnia; and for anxiety. Response and remission rates were also calculated. Safety was assessed by withdrawal rates, adverse events (AEs), body weight, and vital signs. The study was conducted from June 24, 2003, to June 30, 2004. RESULTS: Bupropion XL was superior to placebo at endpoint in reducing the IDS-IVR-30 total score (p = .018) and the energy, pleasure, and interest domain (p = .007) and the insomnia domain (p = .023) scores. IDS-C-30 outcomes were also significant (p < .001; p < .001, and p = .008, respectively). Clinician-rated remission rates were significantly higher with bupropion XL than placebo (32% vs. 18%, IDS-C-30; 41% vs. 27%, IDS-IVR-30), as were response rates (50% vs. 35%, IDS-C-30; 53% vs. 38%, Clinical Global Impressions-Improvement of Illness). Most AEs were mild or moderate. The incidence of a >or= 7% body weight loss was 3.7% with bupropion XL and 1.4% with placebo. CONCLUSION: Bupropion XL was effective and well tolerated in MDD patients with decreased energy, pleasure, and interest. FAU - Jefferson, James W AU - Jefferson JW AD - Madison Institute of Medicine, Madison, WI 53717, USA. jjefferson@healthtechsys.com FAU - Rush, A John AU - Rush AJ FAU - Nelson, J Craig AU - Nelson JC FAU - VanMeter, Susan A AU - VanMeter SA FAU - Krishen, Alok AU - Krishen A FAU - Hampton, Kenneth D AU - Hampton KD FAU - Wightman, Donna S AU - Wightman DS FAU - Modell, Jack G AU - Modell JG LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - United States TA - J Clin Psychiatry JT - The Journal of clinical psychiatry JID - 7801243 RN - 0 (Antidepressive Agents, Second-Generation) RN - 01ZG3TPX31 (Bupropion) RN - BH3B64OKL9 (4-Aminopyridine) SB - IM MH - 4-Aminopyridine MH - Adult MH - Aged MH - Antidepressive Agents, Second-Generation/administration & dosage/adverse effects/*therapeutic use MH - Anxiety/drug therapy/etiology MH - Bupropion/administration & dosage/adverse effects/*therapeutic use MH - Depressive Disorder, Major/complications/*drug therapy MH - Double-Blind Method MH - Fatigue/drug therapy/etiology MH - Female MH - Humans MH - Male MH - Middle Aged MH - Sleep Initiation and Maintenance Disorders/drug therapy/etiology MH - Treatment Outcome EDAT- 2006/07/20 09:00 MHDA- 2007/08/28 09:00 CRDT- 2006/07/20 09:00 PHST- 2006/07/20 09:00 [pubmed] PHST- 2007/08/28 09:00 [medline] PHST- 2006/07/20 09:00 [entrez] AID - 10.4088/jcp.v67n0602 [doi] PST - ppublish SO - J Clin Psychiatry. 2006 Jun;67(6):865-73. doi: 10.4088/jcp.v67n0602.