Abstract | 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. METHOD: 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. CONCLUSION:
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Authors | Mark Hyman Rapaport, Anjana Bose, Hongjie Zheng |
Journal | The Journal of clinical psychiatry
(J Clin Psychiatry)
Vol. 65
Issue 1
Pg. 44-9
(Jan 2004)
ISSN: 0160-6689 [Print] United States |
PMID | 14744167
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antidepressive Agents, Second-Generation
- Placebos
- Citalopram
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Topics |
- Administration, Oral
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Antidepressive Agents, Second-Generation
(administration & dosage, adverse effects, pharmacology)
- Citalopram
(administration & dosage, adverse effects, pharmacology)
- Depressive Disorder
(drug therapy, psychology)
- Double-Blind Method
- Drug Administration Schedule
- Female
- Humans
- Male
- Middle Aged
- Placebos
- Prognosis
- Psychiatric Status Rating Scales
- Recurrence
- Treatment Outcome
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