TADS
Treatment for Adolescents with Depression Study
Patient / Population Intervention / Exposure Comparison Outcome
In 439 adolescents with major depression, fluoxetine + CBT produced the highest 12-week response compared with fluoxetine, CBT or placebo monotherapy.
N
439
Design
4-arm RCT, USA
Endpoint
CGI-improvement response at 12 weeks
Relevance
2
ResultCombination 71%, fluoxetine 61%, CBT 43%, placebo 35%. Suicidal events more frequent on fluoxetine alone.
TADS Team. JAMA. 2004;292(7):807-820. 10.1001/jama.292.7.807
Discussion & critique
Established combination as first-line for moderate-to-severe adolescent depression and flagged the SSRI suicidality signal.