Combination of Prozac, Cognitive Therapy Most Effective Treatment for Depression in Teenagers, Study Finds
The antidepressant Prozac in conjunction with cognitive behavioral therapy is the most effective treatment for depression in adolescents, but Prozac does increase the risk that some patients might harm themselves or others, according to a study published Wednesday in the Journal of the American Medical Association, the Washington Post reports (Vedantam, Washington Post, 8/18). The study, which was conducted between 2000 and 2003, is the first large, federally funded study of an antidepressant drug in adolescents with moderate to severe depression (NIH release, 8/17). The National Institute of Mental Health funded the study, and Prozac manufacturer Eli Lilly provided the drug and placebos but had no role in the study design or data analysis (AP/Wall Street Journal, 8/18). Currently, Prozac is the only medication with FDA approval to treat depression in children (NIH release, 8/17).
Dr. John March, chief of child and adolescent psychiatry at Duke University, and colleagues examined 439 depressed patients between ages 12 and 17 and randomly assigned them to one of four treatment groups: patients who received Prozac and cognitive behavioral therapy; those who only received the medication; patients who received psychotherapy alone; and those who were only given a placebo (Avery, Raleigh News & Observer, 8/18). Researchers excluded from the study adolescents who had a high risk of suicide based on recent suicidal behavior or pervasive suicidal thoughts.
After the 12-week trial, they found that among patients who received both Prozac and cognitive therapy, which teaches problem-solving skills and ways to refocus negative thoughts and behaviors, 71% showed "substantial improvement" on a depression rating scale, the AP/Wall Street Journal reports (AP/Wall Street Journal, 8/18). By comparison, symptoms of depression decreased in 61% of patients who were prescribed only Prozac, 43% of patients who received psychotherapy alone and 35% of those who received placebos.
Thomas Insel, director of NIMH, said the decline in depression in all categories suggests that recognizing and treating depression by any means is important. "Untreated depression is by itself fatal, and even placebo with usual care will confer some protection," he said (Washington Post, 8/18).
Researchers also found that patients who were taking Prozac without also undergoing therapy had more suicidal tendencies during the trial than patients in the three other test groups (AP/Wall Street Journal, 8/18). Of the participants, 11.9% who received Prozac harmed themselves or others by attempting suicide, contemplating suicide, harming themselves without suicidal intent, and being aggressive. Among patients who received Prozac and psychotherapy, 8.4% exhibited such behavior, compared with 4.5% of patients who received only psychotherapy and 5.4% of those who received placebos (Washington Post, 8/18). None of the patients committed suicide.
March acknowledged there is "a slight increase of risk" for harmful behaviors among patients taking Prozac, but he said "the rates of these events are relatively low" (Raleigh News & Observer, 8/18). Study co-author John Curry of Duke University said the rate of suicidal tendencies among the patient pool was too low to determine whether there are real differences among the treatments studied. He added that combining Prozac with psychotherapy seems to mitigate any suicidal risks.
Insel said, "I wouldn't in any way downplay the adverse events," but added that "just because a few kids develop this doesn't mean that you don't treat anybody" (AP/Wall Street Journal, 8/18). Insel said the study shows that "[y]ou can't write a prescription for Prozac the way you write a prescription for penicillin" because of the risk of adverse events. He added that in treating adolescent depression, researchers and physicians must try to distinguish patients who might be adversely affected by antidepressants from those who may benefit from the treatment, the Post reports (Washington Post, 8/18).
The study, which details the first phase of March's research on the matter, was presented in June at a meeting of psychiatric drug researchers (AP/Wall Street Journal, 8/18). The study is available online.
NPR's "All Things Considered" on Tuesday reported on the study. The segment includes comments from Dr. David Fassler, clinical associate professor of psychiatry at the University of Vermont and author of "Help Me, I'm Sad"; Dr. Harold Koplewicz, head of the Child Studies Center at New York University; and March (Baron, "All Things Considered," NPR, 8/17). The complete segment is available online in RealPlayer.
In addition, WAMU's "The Diane Rehm Show," a syndicated NPR program, on Wednesday will include a discussion of the study. Guests on the program are scheduled to include Fassler; Insel; and Dr. John Walkup, associate professor of child psychiatry at the Johns Hopkins Children's Center (Roberts, "The Diane Rehm Show," WAMU, 8/18). The complete segment will be available online in RealPlayer after the broadcast.