Adding fluoxetine to cognitive behavioral therapy failed to further decrease depressive symptoms in youth with moderate-to-severe major depressive disorder, according to findings published in Lancet Psychiatry.
“The modest effectiveness of antidepressants compared with placebo for youth depression suggests that antidepressants might best be used in combination with psychotherapy,” Christopher G. Davey, MBBS, PhD, of Orygen, the National Centre of Excellence in Youth Mental Health, in Melbourne, Australia, and colleagues wrote.
Davey and colleagued examined whether combined treatment with CBT and fluoxetine, the first-choice antidepressant for youth with major depression disorder, was more effective than CBT plus placebo in young people aged 15 to 25 years with moderate-to-severe MDD.
In their randomized, placebo-controlled trial, patients received weekly, 50-minute CBT sessions for 12 weeks plus either one 20 mg capsule of fluoxetine or one placebo pill per day. Participants were interviewed and underwent medical assessments at baseline, week 4, week 8 and week 12 to determine change in the interviewer-rated Montgomery-Åsberg Depression Rating Scale (MADRS) score at 12 weeks.
Overall, 59 patients who received CBT plus placebo and 64 who received CBT plus fluoxetine completed 12-week follow-up.
Although both groups demonstrated reductions in depressive symptoms, the results showed that there was no significant between-group difference in MADRS scores (–1.4; 95% CI, –4.7 to 1.8) nor was there any significant between-group difference for changes in self-reported Quick Inventory of Depressive Symptomatology (–1; 95% CI, –2.7 to 0.7) after 12 weeks of treatment.
However, Davey and colleagues reported a greater decrease in anxiety symptoms in the CBT plus fluoxetine group compared with the CBT plus placebo group (–2.1; 95% CI, –3.9 to –0.3). There were five deaths by suicide in the placebo group and one in the fluoxetine group (P = .21), and no significant between-group differences for other suicidal behaviors.
Exploratory post-hoc analyses indicated that patients aged 18 years and older in the CBT plus fluoxetine group showed had a greater reduction in depressive and anxiety symptoms compared with the CBT plus placebo group.
“Although the question has practical clinical relevance, the additive effects of a second treatment are likely to be reduced by the first treatment, necessitating large samples to show benefits for combined treatments,” the researchers wrote. – by Savannah Demko
Disclosure: Davey report no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.