Escitalopram continuation treatment prevents relapse of depressive episodes.
BACKGROUND
Current guidelines for antidepressant use recommend 4 to 6 months of continuation treatment to prevent relapse of depression following symptom resolution. This study evaluates the efficacy and safety of continuation escitalopram treatment.


METHODS
Outpatients diagnosed with DSM-IV major depressive disorder (male or female, aged 18 to 81 years) who had completed 8 weeks of randomized double-blind treatment with escitalopram, citalopram, or placebo entered an 8-week flexible-dose, open-label phase in which all patients received escitalopram (10-20 mg/day). This study was initiated November 3, 1999, and completed April 5, 2001. Patients who met responder criteria (score of < or = 12 on the Montgomery-Asberg Depression Rating Scale [MADRS]) were randomly assigned in a 2:1 ratio to escitalopram (at the dose each patient was receiving at the end of the open-label phase) or placebo for 36 weeks of double-blind treatment. The primary efficacy variable was time to depression relapse (defined as MADRS score > or = 22 or discontinuation due to an insufficient therapeutic response) from the start of the double-blind treatment phase.


RESULTS
A total of 502 patients received open-label escitalopram treatment and had at least 1 MADRS assessment. A total of 274 evaluable subjects entered the double-blind treatment phase; 93 received placebo and 181 received escitalopram. Time to depression relapse was significantly longer (p =.013) and the cumulative rate of relapse was significantly lower in patients who received escitalopram (26% escitalopram vs. 40% placebo; hazard ratio = 0.56; p =.01). Escitalopram-treated subjects had significantly lower depression ratings than those of placebo-treated patients. Escitalopram continuation treatment was safe and well tolerated. Discontinuation rates due to adverse events were 7% for the placebo group and 4% for the escitalopram-treated group.


CONCLUSIONS
Continuation treatment with escitalopram is effective in preventing relapse into an episode of major depressive disorder.
Rapaport
Mark Hyman
MH
Department of Psychiatry, Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA. Mark.Rapaport@cshs.org
Bose
Anjana
A
Zheng
Hongjie
H
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018687:Antidepressive Agents, Second-Generation / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D015283:Citalopram / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011379:Prognosis; D011569:Psychiatric Status Rating Scales; D012008:Recurrence; D016896:Treatment Outcome
D018687:Antidepressive Agents, Second-Generation; D010919:Placebos; D015283:Citalopram