Lepola 2001 Escitalopram.
Methods | Escitalopram versus placebo Double blind RCT from 8 countries including European countries and Canada Includes the citalopram arm | |
Participants | N=309 (10‐20mg/day Escitalopram n=155; Placebo n=154). Primary care patients 18‐65 years and fulfilling the DSM IV criteria for MDD with a baseline Montgomery Asberg rating of >=22 and <=40. Patients mainly Caucasian, mean age 43 years (SD 11). Exclusions: schizophrenia, bipolar, OCD, eating disorder, mental retardation, MADRS>=5 on item 10 (suicidal thoughts), current treatment on psychotropic drugs except benzodiazepines, ECT, psychotherapy or behavioural therapy. | |
Interventions | After 1 week of single blind placebo phase 8 weeks of 10mg/day Escitalopram or placebo. After 4‐6 weeks could double dose of drugs | |
Outcomes | Withdrawal for all reasons 9/155 (6%) in Escitalopram group , and 15/154 (10%) in placebo group.
Responders >=50% reduction in MADRS =93/146 in Escitalopram group and 68/140 in placebo e group. On MADRS at the 8 week end of trial Escitalopram mean 14.2 (SD not reported) n=146; Citalopram mean 15.4 (SD not reported) and n = 139; Placebo mean = 16.6 (SD not reported) n = 139 |
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Notes | Intention to treat analysis with last observation carried forward. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |