In a national clinical trial, adolescents with moderate to severe depression first given a placebo therapy and then an antidepressant medicine alone or in combination with treatment responded just as well over the long term as participants who received active therapy throughout the study, UT Southwestern Medical Center scientists report.

Scientists observed that at the end of nine months, children and teenagers first given placebo therapy for 12 weeks and then given active therapy had a response rate of 82 percent, in comparison to an 83 percent response rate for participants who received active therapy for the entire period.

The study, available Jan. 15 in the online advance edition of The American Journal of Psychiatry, is the first to address whether delaying effective therapy for adolescents assigned to initial therapy with a placebo group is ethical in research, said Dr. Betsy Kennard, associate professor of psychiatry at UT Southwestern and main author of the study.

"We don't want to put children and teenagers in any therapy that's harmful, and this shows that these adolescents were well cared for and went on to do just as well as the teens who initially received active therapys," Dr. Kennard said. "Without placebo groups, it's difficult to determine the efficacy of a therapy. Now we've shown scientifically that these trials are safe and effective. We do well by these kids".

Dr. Kennard did the research as a secondary analysis in the Treatment for Adolescents with Depression Study (TADS). TADS, led by Dr. John March of Duke University Medical Center, treated 439 adolescents ages 12 to 17 from 13 sites across the country with moderate to severe major depressive disorder. About 50 patients were treated at UT Southwestern.

The main study observed that 12 weeks of therapy with a combination of antidepressant medicine and cognitive behavioral treatment (a talking treatment that addresses thinking and behavior patterns to modify depressed mood) was better than cognitive behavioral treatment alone or placebo therapy.

Dr. Kennard then analyzed what happened to those children in the placebo group. For 12 weeks, placebo participants received education, 30 to 45 minutes with a psychiatry expert, supportive care and clinical management, just like those in the active therapy groups. They also received a pill placebo. About 35 percent of the participants got better from this approach alone.

"Placebo can be misconstrued as if it's a bad thing," Dr. Kennard said. "These adolescents received quite a bit of clinical care, and for some of them, that was enough to help them get well. If at any time a child started to do worse, we would change their therapy no matter what group they were in".

After 12 weeks, most of the 65 percent of the children who did not initially respond to the placebo chose to then receive medicine alone or medicine combined with cognitive behavioral treatment.

Scientists reviewed related effects such as risk of harm, suicidal events, uses of outside therapy and drop-out rates to see if the placebo group patients fared worse.

"In terms of every possible way that we could look at the patients, adolescents first given placebo therapy performed as well or had as positive a response as those given other therapy for the entire 36 weeks," Dr. Kennard said. "So it's OK to consider participating in research, even in a controlled study, because in a well-conducted trial, you receive a considerable amount of clinical care, and there is quite a bit of oversight".

Dr. Kennard, with Dr. Graham Emslie, professor of psychiatry and pediatrics at.

UT Southwestern, is currently doing research that employs a cognitive behavioral treatment developed at UT Southwestern that was shown in a pilot study to reduce significantly depression relapse rates in adolescents.

Other UT Southwestern scientists involved in the TADS placebo outcomes study were Dr. Emslie; Taryn Mayes, faculty associate in psychiatry; and Jennifer Hughes, student research assistant in psychiatry.

In addition to Duke University Medical Center, scientists from Carolinas Medical Center, Case Western Reserve University, Children's Hospital of Philadelphia, Columbia University, Johns Hopkins University, University of Nebraska, New York University, University of Chicago/Northwestern University, Cincinnati Children's Hospital Medical Center, University of Oregon, and Wayne State University participated in this research.

The study was funded by the National Institute of Mental Health.


Posted by: Emily    Source

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