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The Treatment for Adolescents With Depression Study (TADS): long-term effectiveness and safety outcomes.
Arch Gen Psychiatry. 2007 Oct; 64(10):1132-43.AG

Abstract

CONTEXT

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.

OBJECTIVE

To report effectiveness outcomes across 36 weeks of randomized treatment.

DESIGN AND SETTING

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.

PARTICIPANTS

Three hundred twenty-seven patients aged 12 to 17 years with a primary DSM-IV diagnosis of major depressive disorder.

INTERVENTIONS

All treatments were administered per protocol.

MAIN OUTCOME MEASURES

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.

RESULTS

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%).

CONCLUSIONS

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.

Authors+Show Affiliations

Department of Psychiatry, Duke University Medical Center, Durham, NC 27710, USA. jsmarch@duke.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17909125

Citation

March, John S., et al. "The Treatment for Adolescents With Depression Study (TADS): Long-term Effectiveness and Safety Outcomes." Archives of General Psychiatry, vol. 64, no. 10, 2007, pp. 1132-43.
March JS, Silva S, Petrycki S, et al. The Treatment for Adolescents With Depression Study (TADS): long-term effectiveness and safety outcomes. Arch Gen Psychiatry. 2007;64(10):1132-43.
March, J. S., Silva, S., Petrycki, S., Curry, J., Wells, K., Fairbank, J., Burns, B., Domino, M., McNulty, S., Vitiello, B., & Severe, J. (2007). The Treatment for Adolescents With Depression Study (TADS): long-term effectiveness and safety outcomes. Archives of General Psychiatry, 64(10), 1132-43.
March JS, et al. The Treatment for Adolescents With Depression Study (TADS): Long-term Effectiveness and Safety Outcomes. Arch Gen Psychiatry. 2007;64(10):1132-43. PubMed PMID: 17909125.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Treatment for Adolescents With Depression Study (TADS): long-term effectiveness and safety outcomes. AU - March,John S, AU - Silva,Susan, AU - Petrycki,Stephen, AU - Curry,John, AU - Wells,Karen, AU - Fairbank,John, AU - Burns,Barbara, AU - Domino,Marisa, AU - McNulty,Steven, AU - Vitiello,Benedetto, AU - Severe,Joanne, PY - 2007/10/3/pubmed PY - 2007/10/19/medline PY - 2007/10/3/entrez SP - 1132 EP - 43 JF - Archives of general psychiatry JO - Arch. Gen. Psychiatry VL - 64 IS - 10 N2 - CONTEXT: 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. OBJECTIVE: To report effectiveness outcomes across 36 weeks of randomized treatment. DESIGN AND SETTING: 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. PARTICIPANTS: Three hundred twenty-seven patients aged 12 to 17 years with a primary DSM-IV diagnosis of major depressive disorder. INTERVENTIONS: All treatments were administered per protocol. MAIN OUTCOME MEASURES: 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. RESULTS: 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%). CONCLUSIONS: 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. SN - 0003-990X UR - https://www.unboundmedicine.com/medline/citation/17909125/The_Treatment_for_Adolescents_With_Depression_Study__TADS_:_long_term_effectiveness_and_safety_outcomes_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&amp;PAGE=linkout&amp;SEARCH=17909125.ui DB - PRIME DP - Unbound Medicine ER -