PMID- 16582045 OWN - NLM STAT- MEDLINE DCOM- 20060803 LR - 20221207 IS - 1064-7481 (Print) IS - 1064-7481 (Linking) VI - 14 IP - 4 DP - 2006 Apr TI - A double-blind, placebo-controlled study of venlafaxine and fluoxetine in geriatric outpatients with major depression. PG - 361-70 AB - BACKGROUND: Despite the high prevalence of depression in elderly patients, few well-designed, placebo-controlled studies of antidepressants have been conducted in this population. This masked, placebo-controlled trial assessed the efficacy and safety of venlafaxine and fluoxetine in depressed patients older than 65 years. METHOD: Three hundred patients were randomly assigned to treatment with venlafaxine immediate release ([IR]; N = 104), fluoxetine (N = 100), or placebo (N = 96) in an eight-week trial. Venlafaxine doses were titrated from 37.5 to 225 mg per day and fluoxetine doses were titrated from 20 to 60 mg per day, as necessary, over 29 days. Efficacy variables included the 21-item Hamilton Depression Rating Scale (HAM-D21) total score, HAM-D21 depressed mood item score, scores on the Montgomery Asberg Depression Rating Scale (MADRS), Clinical Global Impression-Severity of Illness (CGI-S) and Improvement (CGI-I) scales, and rates of response (based on change from baseline HAM-D or MADRS score or CGI-I score) and remission (HAM-D17 < or =7). For the purposes of this report, efficacy analyses are focused on the HAM-D21 total score. Safety assessments included monitoring of adverse events (AEs), physical examinations, vital signs assessments, laboratory determinations, and electrocardiograms. RESULTS: In all three of the treatment groups, there was a significant reduction at week 8 compared with the baseline HAM-D21 total score. However, there were no significant differences among the three treatment groups on the change in HAM-D21, MADRS, or CGI scores from baseline to week 8. There was no statistically significant difference in the proportion of remitters at the last on-therapy visit. The incidence of individual AEs was higher in the venlafaxine group (27%) compared with patients taking fluoxetine (19%) or placebo (9%). CONCLUSION: In this study, there was no significant difference in efficacy among placebo, venlafaxine, and fluoxetine for the treatment of depression. FAU - Schatzberg, Alan AU - Schatzberg A AD - Stanford University School of Medicine, Stanford, CA 94605-5548, USA. afschatz@leland.stanford.edu FAU - Roose, Steven AU - Roose S LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Am J Geriatr Psychiatry JT - The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry JID - 9309609 RN - 0 (Antidepressive Agents, Second-Generation) RN - 0 (Cyclohexanols) RN - 0 (Serotonin Uptake Inhibitors) RN - 01K63SUP8D (Fluoxetine) RN - 7D7RX5A8MO (Venlafaxine Hydrochloride) SB - IM MH - Aged MH - Ambulatory Care MH - Antidepressive Agents, Second-Generation/*therapeutic use MH - Cyclohexanols/*therapeutic use MH - Demography MH - Depressive Disorder, Major/diagnosis/*drug therapy/*psychology MH - Double-Blind Method MH - Female MH - Fluoxetine/*therapeutic use MH - Humans MH - Male MH - Selective Serotonin Reuptake Inhibitors/*therapeutic use MH - Severity of Illness Index MH - Surveys and Questionnaires MH - Venlafaxine Hydrochloride EDAT- 2006/04/04 09:00 MHDA- 2006/08/04 09:00 CRDT- 2006/04/04 09:00 PHST- 2006/04/04 09:00 [pubmed] PHST- 2006/08/04 09:00 [medline] PHST- 2006/04/04 09:00 [entrez] AID - S1064-7481(12)60685-X [pii] AID - 10.1097/01.JGP.0000194645.70869.3b [doi] PST - ppublish SO - Am J Geriatr Psychiatry. 2006 Apr;14(4):361-70. doi: 10.1097/01.JGP.0000194645.70869.3b.