The Treatment for Adolescents With Depression Study (TADS): Long-term effectiveness and safety outcomes

University of Texas at Austin, Austin, Texas, United States
Archives of General Psychiatry (Impact Factor: 14.48). 11/2007; 64(10):1132-43. DOI: 10.1001/archpsyc.64.10.1132
Source: PubMed

ABSTRACT The Treatment for Adolescents With Depression Study evaluates the effectiveness of fluoxetine hydrochloride therapy, cognitive behavior therapy (CBT), and their combination in adolescents with major depressive disorder.
To report effectiveness outcomes across 36 weeks of randomized treatment.
Randomized, controlled trial conducted in 13 academic and community sites in the United States. Cognitive behavior and combination therapies were not masked, whereas administration of placebo and fluoxetine was double-blind through 12 weeks, after which treatments were unblinded. Patients assigned to placebo were treated openly after week 12, and the placebo group is not included in these analyses by design.
Three hundred twenty-seven patients aged 12 to 17 years with a primary DSM-IV diagnosis of major depressive disorder.
All treatments were administered per protocol.
The primary dependent measures rated blind to treatment status by an independent evaluator were the Children's Depression Rating Scale-Revised total score and the response rate, defined as a Clinical Global Impressions-Improvement score of much or very much improved.
Intention-to-treat analyses on the Children's Depression Rating Scale-Revised identified a significant time x treatment interaction (P < .001). Rates of response were 73% for combination therapy, 62% for fluoxetine therapy, and 48% for CBT at week 12; 85% for combination therapy, 69% for fluoxetine therapy, and 65% for CBT at week 18; and 86% for combination therapy, 81% for fluoxetine therapy, and 81% for CBT at week 36. Suicidal ideation decreased with treatment, but less so with fluoxetine therapy than with combination therapy or CBT. Suicidal events were more common in patients receiving fluoxetine therapy (14.7%) than combination therapy (8.4%) or CBT (6.3%).
In adolescents with moderate to severe depression, treatment with fluoxetine alone or in combination with CBT accelerates the response. Adding CBT to medication enhances the safety of medication. Taking benefits and harms into account, combined treatment appears superior to either monotherapy as a treatment for major depression in adolescents.

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Available from: Benedetto Vitiello, Jan 13, 2014
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    • "According to some studies, CBT may be most effective in reducing suicidal behaviour in combination with another therapy (usually pharmacological) (Leitner, Barr & Hobby, 2008; March et al., 2004). Contrary research has found CBT more effective when decoupled from pharmacological treatment; March et al. (2007) found suicidal events were more common in patients receiving fluoxetine therapy (14.7%) than combination therapy (8.4%) or CBT alone (6.3%). Fluoxetine as a means for suicide by serotonin toxicity may account for this higher percentage (Wu & Deng, 2011). "
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    • "for the SSRI given the failure of fluoxetine to separate from placebo on one of its two primary outcome measures. After the TADS acute 12-week stage, partial and non-responders to all treatments were openly treated (March et al., 2007). All treatment conditions converged by 30 weeks and remained so by week 36. "
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    • "However, there is also contradictory pragmatic research that shows CBT in combination with antidepressants to be no more effective than “routine specialist care” and antidepressant treatment [22•]. Furthermore, there is evidence that after a longer period of follow-up, treatments with CBT alone, fluoxetine alone, and combination treatment converge [31] and show similarly low rates of deterioration 12 months after cessation of treatment [32•], suggesting that CBT is a reasonable option as monotherapy for adolescent depression. However, CBT is generally difficult for adolescents with cognitive problems such as learning disabilities. "
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