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AACAP: Medication/Therapy Combination More Effective in Adolescent Depression than Either as Monotherapy By Paula Moyer WASHINGTON, DC -- October 25, 2004 -- Adolescents with major depressive disorder get more symptom relief from a combination of fluoxetine (Prozac) and cognitive behavioral therapy (CBT) than they do from either as monotherapy, according to investigators who presented their findings here October 23rd at the 51st annual meeting of the American Academy of Child and Adolescent Psychiatry. Further, the combination therapy and each as monotherapy are more effective than placebo, said principal investigator John S. March, MD. Dr. March, who spearheaded the Teenage Depression Study (TADS), is the director of the Program in Child and Adolescent Anxiety at Duke University Medical Center in Durham, North Carolina. He reported the efficacy findings on behalf of the TADS Team at a symposium devoted to TADS. The investigators recruited 439 adolescents with major depressive disorder and randomly assigned them to 1 of 4 arms: medication management with fluoxetine, medication management with placebo, cognitive-behavior therapy (CBT), or a combination of CBT and fluoxetine. There were 107 patients in the combination group, 111 in the CBT monotherapy group, 109 in the fluoxetine monotherapy group, and 112 in the placebo group. The placebo-controlled phase of the study lasted 12 weeks. The investigators used 2 instruments to measure response to treatment: the Child Depression Rating Scale-Revised total score (CDRS-R) and the Clinical Global Impression-Improvement (CGI-I). The participants' mean baseline CDRS-R was 60.0 ± 10.4. The severity as assessed by CGI was an average of 4.8 ± 0.8; severity by the Child-Global Assessment Scale averaged 59.6 ± 7.5. At 12 weeks, 10% of the original subjects dropped out due to lack of efficacy, adverse events, or other study-related issues. Another 10% were prematurely terminated due to unrelated medical problems or other issues that had developed and taken priority over participation in the study. The dropout and premature termination rates did not differ among the treatment arms, Dr. March said. Assessments at weeks 6 and 12 showed that most of the response to treatment occurred in the first 6 weeks. By the end of the 12-week period, CBT monotherapy did not differ significantly from placebo; with each group having a CDRS-R averaging approximately 45. At that point, combination therapy produced the greatest reduction on the CDRS-R, with patients in that group having an average score of 30; the fluoxetine monotherapy group had an average CDRS-R score of 35. These results held true even when adjusting for dropouts and premature terminations, Dr. March said, and they were validated when the subjects were evaluated on the Reynolds Adolescent Depression Scale (RADS). The response rates, as defined by CGI-I results of "improved" or "much improved," were 71% for the combination group, 51% for the fluoxetine monotherapy group, 40% for the CBT monotherapy group, and 34% for the placebo group. An assessment of numbers needed to treat showed that it would be necessary to treat 2 patients by combination therapy to see a result, 4 by fluoxetine alone, and 12 by CBT alone. "We don't know yet why there was such a low response to CBT monotherapy and why there was such low placebo response," Dr. March said. "We would have expected a 60% response rate for CBT alone, and a 40% placebo response rate." One thought is that the patients recruited to TADS were sicker than those that are typically recruited to depression trials, and that the study period was shorter than is typically seen in CBT studies. Patients will be followed at 18 weeks and 36 weeks, as well, Dr. March said. Eli Lilly, the manufacturer of Prozac, provided the medication used in the study. [Presentation title: The Treatment for Adolescents with Depression Study (TADS): Efficacy Results Abstract: 49B] E-mail this page to a friend or colleague! To print, use this version