Clinical trial suggests that paroxetine may successfully treat adolescents; however, 40 percent of patients failed to respond to treatment
A Brown-led study has produced some good news for the treatment of depression in teens. The largest clinical trial, treating major depression in adolescents with antidepressants, suggests that paroxetine, sold under the brand name Paxil, may be successful.
However, almost 40 percent of patients failed to respond to paroxetine. This mirrors the typical non-responder rate in such trials and underscores the need for more research into treating teen-age depression, said study leader Martin Keller, M.D.
The study appears in the July issue of the Journal of the Academy of Child and Adolescent Psychiatry. Researchers examined two different classes of anti-depressants that work in adults. This was the first large-scale, double-blind, placebo-controlled comparison of a selective serotonin reuptake inhibitor (SSRI), paroxetine, and a placebo-controlled comparison with a tricyclic antidepressant, imipramine, to treat teens with major depression. GlaxoSmithKline, makers of Paxil, funded the research.
The study involved 275 patients at 12 psychiatric centers. Across several outcome measures, paroxetine lessened depression symptoms and improved patient moods, compared to imipramine and to placebo. In the primary rating scale for depression, paroxetine produced a 63-percent response rate compared to 50 percent for imipramine and 46 percent for placebo.
The acute phase of the trial lasted eight weeks, with a final average daily dose of 28 mg of paroxetine.
"This is the first substantial evidence of a safe and effective treatment with an anti-depressant for adolescents," said Keller, professor and chairman of the Department of Psychiatry and Human Behavior.
About 15 percent of teens suffer from major depression, characterized by frequent, protracted bouts and considerable social and academic impairments. Suicide, strongly linked to major depression, is the second leading cause of death in teens.
Until now, there were few tightly controlled, large-scale randomized trials of antidepressants in teens. Most basic questions have remained unanswered about how to treat this age group. In fact, the Food and Drug Administration does not currently approve any antidepressant for use in teens. At least two large-scale studies, involving drug safety, efficacy, metabolism and action, are necessary for such a classification.
"This one study provides such evidence," Keller said. "Our hope is that this study provides clinicians and families with an understanding of what can be done for a depressed adolescent in terms of an effective treatment."
One of the study’s limitations is that 37 percent of patients failed to respond to the paroxetine, which is a typical non-responder rate in SSRI trials, Keller said. He and Brown colleagues are currently recruiting adolescents for a five-year study of how to care for patients with major depression for whom initial treatment with any of the five most commonly prescribed SSRIs does not entirely work.
"That is what happens in the real world when you treat people - they often get partially better," said Henrietta Leonard, professor of psychiatry and human behavior and one of Keller’s co-investigators in the new study. "We don't have direction as to what's good, safe, effective treatment" at that point.
The National Institute of Mental Health is funding the six-site nationwide study of 400 teens. Researchers are recruiting adolescents between the ages of 12 and 18 who are currently in treatment for depression. Individuals must be taking an SSRI for at least six weeks with little or no improvement. Researchers will try variations of anti-depressants and cognitive behavior therapy with the subjects.
The Brown study site is at Butler Hospital. For more information, call 1-866-279-KIDS.