A randomized, double-blind, placebo-controlled study of citalopram in adolescents with major depressive disorder.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 16702897 · doi:10.1097/01.jcp.0000219051.40632.d5
What was done
In a European multicenter, double-blind trial, 244 adolescents aged 13 to 18 years with major depressive disorder were randomized to receive citalopram (n = 124) or placebo (n = 120) for 12 weeks. Outcomes were assessed using the Kiddie-SADS-P and the Montgomery Asberg Depression Rating Scale (MADRS).
What was found
No significant differences in symptom score improvements from baseline to week 12 were found between citalopram and placebo. Response rates were 59% to 61% in both groups on Kiddie-SADS-P and MADRS (>=50% reduction). Remission (MADRS <= 12) was 51% with citalopram and 53% with placebo. In a post hoc subgroup not receiving concurrent psychotherapy (>2/3 received psychotherapy overall), citalopram showed higher response (Kiddie-SADS-P: 41% vs 25%; MADRS: 52% vs 22%) and remission (45% vs 19%). Adverse events occurred in 75% on citalopram and 71% on placebo; serious adverse events occurred in 14% to 15% in both groups. Suicide attempts/thoughts/tendencies were reported in 14 citalopram versus 5 placebo patients (not significant), while suicidal ideation item worsening occurred in 8% on citalopram versus 18% on placebo.
Why it matters
This trial demonstrates no overall therapeutic benefit of citalopram over placebo in adolescent depression, emphasizing the high placebo response rate in this population and the confounding role of background psychotherapy.
Limits
One third of patients in both groups dropped out before week 12. Uncontrolled concurrent psychotherapy in over two thirds of participants compromised the ability to evaluate the primary drug effect, and dosage details are not provided in the abstract.
Cited by
- supports SSRIs improve major depressive disorder by approximately 50% in randomized controlled trials.