Magazine article Clinical Psychiatry News

Stick with Positive Trial Results When Prescribing Antidepressants

Magazine article Clinical Psychiatry News

Stick with Positive Trial Results When Prescribing Antidepressants

Article excerpt

NEW YORK--Sticking with medications that have shown positive results in randomized trials is important when it comes to treating pediatric depression, according to Dr. Karen Dineen Wagner.

The Food Drug Administration has approved only two drugs for treatment of pediatric depression--fluoxetine for patients aged 8 to 17 years, and escitalopram for those aged 12 to 17--but she pointed out that citalopram also showed positive results in a published trial, and that sertraline has shown positive results in ages 6 to 17 in an a priori pooled analysis of two studies (even though the individual trials were negative).

"Keep within those we know about," Dr. Wagner advised at a pharmacology update, sponsored by the American Academy of Child and Adolescent Psychiatry (AACAP). She pointed out that budeprion, although widely prescribed, has not been shown effective in any published trial of a pediatric population. "Some parents want to know: Is this drug FDA approved [for use in children]? If you use medications that are not FDA-approved, you want to stay as best you can with those that have shown some efficacy [for use] in children, in the age group you're treating."

Dr. Wagner said the only published trial of omega-3 fatty acids in prepubertal depression was small--involving 28 children--and while 70% of those in the treatment arm showed at least a 50% improvement, none of those on placebo did so (Am. J. Psychiatry 2006; 163: 1098-100).

"Never in any study I've been involved in has there been a zero placebo response rate," said Dr. Wagner, who is the Marie B. Gale Centennial Professor and vice chairwoman of the department of psychiatry and behavior sciences at the University of Texas Medical Branch in Galveston. "But who knows? It was published."

Many of the trials that failed to show positive results, she said, did so not because the treatment arms showed low response rates, but because the placebo arms showed high improvement rates.

"What makes the placebo response rates so high in children?" Dr. Wagner asked. She cited a recent metaanalysis showing that the chief predictor of a high placebo response rate is the number of study sites (Am. J. Psychiatry 2009; 166: 42-9).

"Another predictor of a high placebo response rate is the baseline of severity. If a child is enrolled with moderate depression, it's very likely they'll respond to placebo as well as to medication."

Although the Treatment for Adolescents With Depression Study (TADS) showed that cognitive-behavioral therapy (CBT) can be as effective as medication in improving symptoms at 36 weeks, Dr. Wagner noted that it was less effective at 12 weeks (Arch. Gen. Psychiatry 2007; 64: 1132-44; Am. J. Psychiatry 2009; 166: 337-44).

"What [the study] shows is that CBT is effective, but it takes a while to work," she said. "Parents have to be advised about that. Some will get better early, but for the most part it will take time. The medication will work faster. For moderate to severe depression, CBT just may take too long."

She pointed to another analysis of TADS that found that the rate of attempted suicides or suicidal ideation between those on medication and those on placebo did not vary over the course of the study (J. Clin. Psychiatry 2009; 70: 741-7). "You would think if there was a drug effect, there would be a timing to it," she said. …

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