PHOENIX - In the midst of a worldwide debate on whether depressed children should be treated with antidepressant drugs like Prozac, a landmark government-financed study has found that Prozac helps teenagers overcome depression far better than talk therapy. But a combination of the two treatments, the study found, produced the best result.

The study, sponsored by the National Institute of Mental Health, was the first to compare psychotherapy and drug treatment for adolescents. Statistically, the researchers found, talk therapy was no more effective in reducing the teenagers’ depression than treatment with dummy pills. But when combined with drug treatment, psychotherapy appeared to provide added benefit and to reduce the risk of suicide.

The findings are likely to serve as a balm to psychiatrists, pediatricians and others who increasingly prescribe antidepressants to teenagers and children. Millions take the drugs.

Experts said the study is notable for its size and for the fact that it was carried out without drug company money. Data on the effects of antidepressants in adolescents is in short supply. Most studies of the question have been small trials sponsored by pharmaceutical companies and have failed to show that the drugs are effective for depressed teenagers.

“This study should put to rest doubts about whether these drugs work in teenagers with severe depression,” said Dr. Graham Emslie, a professor of psychiatry at the University of Texas Southwestern Medical Center and an author of the study, which was presented at a meeting of psychiatric drug researchers recently.

Still, the findings are unlikely to resolve the controversy over whether Prozac and similar drugs lead a small number of teens and children to become suicidal.

Such concerns led the federal Food and Drug Administration (FDA) to warn earlier this year that patients taking the drugs should be watched closely for signs of suicide or other harmful behavior in the first weeks of therapy. The FDA is amid a reanalysis of suicidal events in drug-company trials of antidepressants in children and teenagers. British drug regulators have banned the use of all but Prozac in those under the age of 18.

The government study, called the Treatment for Adolescents with Depression Study, or TADS, involved 439 teenagers ages 12 to 17 who were suffering from moderate to severe depression. The adolescents were randomly assigned to receive Prozac, a form of talk therapy known as cognitive behavioral therapy, placebo pills or a combination of Prozac and talk therapy, for a period of 36 weeks.

The researchers collected data on the subjects for a year, but they have so far only analyzed information from the first 12 weeks of the study. Of the teenagers recruited for the study, 378 completed the first 12 weeks of treatment. Their mean age was 15. Depression levels were measured using several common psychological scales.

Using one measurement scale, the researchers found that after 12 weeks, 71 percent of the subjects who received Prozac and talk therapy responded well to treatment, compared with 61 percent of those who received Prozac alone, 43 percent of who received talk therapy alone and 35 percent of those who received a placebo treatment. By another measure, talk therapy alone fared no better than treatment with dummy pills.

The researchers also found that patients in the study became significantly less suicidal, no matter which treatment they were given. No patient committed suicide during the trial. But the risk of a suicide attempt among the teenagers given Prozac was twice that of those who did not receive Prozac, known generically as fluoxetene.

Dr. John March, a professor of psychiatry at Duke University and the study’s lead investigator, said that the findings showed that Prozac’s benefits for depressed teens far outweighed its risks.

“The take-home message is that these adverse events are extremely rare,” he said.

March acknowledged, however, that the controversy about suicide and antidepressant therapy is far from resolved.

“We’re all holding our breath to see what the FDA is going to do,” he said.

Psychologists, who are often the providers of talk therapy and who cannot prescribe drugs, are likely to be disappointed in the finding that cognitive behavioral therapy was little better than a sugar pill for depressed teens. A recent major trail comparing drugs with talk therapy in children with attention-deficit disorder also showed that the drugs worked better.

But the findings of another study presented also recently suggest that for some psychiatric conditions, talk therapy may in fact be more effective than antidepressants. That study compared cognitive behavioral therapy with Pfizer’s Zoloft, an antidepressant similar to Prozac, in teenagers who suffered from obsessive-compulsive disorder. The teenagers who received the talk therapy, the study found, improved more than those given the drug treatment.

Gardiner Harris
International Herald Tribune
Date: June 3, 2004