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.


METHODS
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.


BACKGROUND
clinicaltrials.gov Identifier: NCT00162916.
Rapoport
Mark J
MJ
Sunnybrook Health Sciences Center, University of Toronto, Ontario, Canada. mark.rapoport@sunnybrook.ca
Mitchell
Robert A
RA
McCullagh
Scott
S
Herrmann
Nathan
N
Chan
Florance
F
Kiss
Alex
A
Feinstein
Anthony
A
Lanctôt
Krista L
KL
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D001930:Brain Injuries / Q000150:complications* / Q000188:drug therapy* / Q000523:psychology; D015283:Citalopram / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D010555:Personality Inventory / Q000706:statistics & numerical data; D011594:Psychometrics; D055502:Secondary Prevention; D055815:Young Adult
D018687:Antidepressive Agents, Second-Generation; D015283:Citalopram