Nonetheless, adolescent suicide rates have been falling over the last decade. “Widespread use of antidepressants does not seem to be leading to an epidemic of completed suicides,” he said. “Whether the falling suicide rate is actually related to the benefits of antidepressant medication–and there's some supportive evidence suggesting that might be the case–we don't know yet. Keep following this story.”
Lessons From TADS
The Treatment for Adolescents With Depression Study (TADS) was a multicenter, randomized trial comparing treatment with fluoxetine alone, cognitive-behavioral therapy (CBT) alone, the two combined, and placebo. In the initial 12-week phase of the trial, the response rate for patients in the combination group was 71%, and for the fluoxetine alone group it was 61% (JAMA 2004;292:807-20).
The 43% response rate in the CBT alone group did not differ significantly from the placebo response rate of 35%, said Dr. Waslick, who was an investigator for the trial.
Longer-term data from TADS have yet to be analyzed, but the emerging message is that the combination of medication and CBT is best. This finding was particularly important for the most severely ill patients in the study, who clearly needed medication to get better, he said.
The trial was funded by the National Institute of Mental Health and has a degree of credibility not necessarily shared by all industry-funded trials, which typically have been done under the condition of pediatric exclusivity.
This incentive provides drug companies with a 6-month extension on their patent if they undertake studies of the agent in pediatric populations, but they are under no obligation to publish their findings. Examination of industry-generated data on antidepressants–some of which came out only under the Freedom of Information Act–has found that, aside from fluoxetine, the evidence of their efficacy in children is “underwhelming.”