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

May 6, 2010The Journal of clinical psychiatry

Antidepressant use after traumatic brain injury for major depression: a randomized trial

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Abstract

Relapse occurred in 52.4% of subjects during a 40-week follow-up after major depression remission due to traumatic brain injury.

Of the 25 subjects who achieved remission, 21 were randomly assigned to citalopram or placebo.
Citalopram was administered at a dose of 20 mg to 50 mg per day.
No significant difference in relapse rates was observed between the citalopram group (50.0%) and the placebo group (54.5%).
The mean time to relapse was 23.52 weeks, with a standard deviation of 16.6 weeks.
Continuation treatment with citalopram may not effectively prevent relapse in this patient population.

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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 χ² = 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.

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

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