A Randomized Controlled Trial of Antidepressant Continuation for Major Depression Following Traumatic Brain Injury

Objective: This study examines whether continuation therapy with citalopram can prevent a relapse following remission of major depression due to traumatic brain injury. Method: After 65 subjects with DSM-IV- diagnosed major depression following traumatic brain injury were treated with open-label citalopram (20 mg to 50 mg/d), 25 subjects (38.5%) met criteria for remission. Of those, 21 (84.0%) were randomly assigned to either same-dose citalopram or placebo and followed monthly over 40 weeks. Remission was defined as a Hamilton Depression Rating Scale (HDRS) score of <= 7 or a Clinical Global Impressions-Improvement rating of "much improved" or better. The main outcome variable was the presence of relapse, as defined by meeting criteria for major depressive episode according to the DSM-IV and an HDRS score >= 16. Data were collected from February 16, 2005, to May 5, 2008. Results: Ten subjects were randomly assigned to citalopram and 11 to placebo. There were 3 dropouts, including 1 for adverse drug effects (diarrhea). Relapse occurred in 11 subjects (52.4%), with a mean +/- SD time to relapse of 23.52 +/- 16.6 weeks. The groups did not differ in relapse rates (drug: 50.0% [5/10] vs placebo: 54.5% [6/11], Fisher exact test, P = .835) or time to relapse (log rank test chi(2) = 0.148, P = .700). Conclusions: The present study suggests important limitations of continuation pharmacotherapy in the prevention of relapse of major depression following traumatic brain injury. Trial Registration: clinicaltrials.gov Identifier: NCT00162916 J Clin Psychiatry 2010;71(9):1125-1130 (C) Copyright 2010 Physicians Postgraduate Press, Inc.