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CAMBRIDGE, England -- Adding weekly cognitive behavioral therapy sessions to a daily fluoxetine (Prozac) regimen was no more beneficial for depressed adolescents than medication alone, researchers here found.
CAMBRIDGE, England, July 20 -- Adding weekly cognitive behavioral therapy sessions to a daily fluoxetine (Prozac) regimen was no more beneficial for depressed adolescents than medication alone, researchers here found.
By 28 weeks, 52% of the patients in the drug plus cognitive behavioral therapy group were "much or very much improved," but 61% of the medication-only group reached the same level, Ian Goodyer, M.D., of Cambridge University, and colleagues reported in the July 20 issue of BMJ.
Moreover, 17% of patients in the selective serotonin reuptake inhibitor (SSRI) group versus 25% of the cognitive behavioral therapy group "reported no response or worsening of symptoms."
Dr. Goodyer added that the study (Adolescent Depression Antidepressant and Psychotherapy Trials [ADAPT]) showed no "evidence of a protective effect of cognitive behavioral therapy on suicidal thinking or action."
But, he said, the researchers found no increase in suicidality associated with SSRI use either. He did note, however, that the study "was not powered to detect such a difference."
The authors noted that their findings differ from those of a U.S. study (Treatment for Adolescents with Depressions [TADS]), which showed combined treatment to be more effective than fluoxetine alone on some outcome measures, including the risk of suicide.
From 2000 through 2004 Dr. Goodyer and colleagues randomized 208 adolescents with moderate to severe depression to SSRI (fluoxetine) plus routine care (n=103) or 12 weeks of weekly cognitive behavioral therapy in addition to SSRI plus routine care. The participants were ages 11 to 17.
Fluoxetine was initiated at 10 mg daily for one week, increasing to 20 mg for five weeks. If there was no response, the dose was increased to a maximum of 60 mg daily. The mean study dose was 30 mg/day in both groups.
The 12 week active treatment phase was followed by a 16 week maintenance phase in which cognitive behavioral therapy was offered every other week for a total of 19 sessions. Routine care included nine outpatient visits over 28 weeks.
The main outcome measure was change in score on Health of the Nation outcome scale from baseline to 12 weeks and 28 weeks. Secondary measures included improvement on rate and mood scales assessed by participants and observers as well as suicidality score from the K-SADS-PL depression section.
One possible explanation for the difference in findings between his study and the U.S. one, Dr. Goodyer said, is the difference in the populations enrolled. He pointed out that participants in his study "were probably the most severely impaired in any randomized controlled trial to date. Importantly, we did not exclude any cases on the basis of suicidality."
Additionally, he said, some of the cognitive behavioral sessions were conducted by therapists not fully trained in the technique and delivered the sessions under supervision.
Dr. Goodyer and colleagues wrote that "ratings of audiotapes of sessions showed that trained [cognitive behavioral] therapists delivered somewhat better treatment in this study" than those who worked under supervision. But this apparent difference "did not result in improved outcome."
In an editorial that accompanied the study, Philip Hazell, M.D., of the University of Sydney, pointed out that adolescents randomized to the SSRI alone arm, actually received "a high level of clinical care, with frequent clinical reviews and rigorous monitoring of the benefit of treatment and adverse events. The implication for clinical practice is that good quality pharmacological treatment involves more than simply writing the prescription."
Finally, Dr. Goodyer and colleagues concluded that because the study was designed as a superiority trial it was not powered to detect equivalence. As a result, "we cannot say there is evidence that treatments are equally effective."