Child Anxiety: Therapy Plus Zoloft Best Study Shows Cognitive Behavioral Therapy, Zoloft Work for Child Anxiety -- But Combo Is Best

Dec. 24, 2008 - Cognitive behavioral therapy (CBT) and Zoloft are effective treatments for childhood anxiety disorders -- but the combination works best, a government-funded study shows.

Anxiety disorders and social phobias limit the lives of at least one in 10 children. Yet up to half of these kids aren't helped by short-term treatment with psychotherapy alone or medications alone.

That's why Johns Hopkins researcher John T. Walkup, MD, and colleagues led a multi-institution, government-funded study to see whether combination treatment would help.

The researchers enrolled 488 children and teens age 7 to 17 years. All suffered separation anxiety disorder, generalized anxiety disorder, or social phobia.

There were four different treatment groups:

• 76 kids got inactive placebo pills.
• 133 kids got Zoloft alone -- beginning with 25 milligrams per day and adjusted up to 200 milligrams per day within eight weeks, including eight 30- to 60-minute sessions to rate treatment response and adverse events.
• 139 kids got CBT alone -- 14 one-hour sessions based on the Coping Cat program.
• 140 kids got combination treatment with CBT and Zoloft.

After 12 weeks:

• 24% of the kids in the placebo group were "very much" or "much" improved.
• 55% of the kids in the Zoloft group were "very much" or "much" improved.
• 60% of the kids in the CBT group were "very much" or "much" improved.
• 81% of the kids in the CBT/Zoloft combination group were "very much" or "much" improved.

Walkup and colleagues conclude that all three of the active treatments -- CBT, Zoloft, or the combination -- are effective short-term treatments for kids with anxiety disorders.

"Among these effective therapies, combination therapy provides the best chance for a positive outcome," they conclude.

Zoloft treatment worked the fastest, with rapid initial improvement but little additional improvement after eight weeks of treatment. CBT took eight to 12 weeks to work.

Most kids with anxiety disorders don't get diagnosed or treated, notes an editorial by Graham J. Emslie, MD, of the University of Texas Southwestern Medical Center, Dallas.

That's too bad, he says, because research now shows that untreated childhood anxiety persists into adulthood.

"This trial answers the most compelling question about the treatment of anxiety disorders: Treatment is indicated," Emslie states.

Zoloft is an SSRI antidepressant. Like other members of its class, the drug has been linked to suicidal thoughts in children and adults. But in the Walkup study, there were no more suicidal thoughts in kids taking Zoloft than in kids taking placebo pills.

However, kids taking Zoloft reported more insomnia, fatigue, sedation, and restlessness than kids in the CBT group.

Zoloft is made by Pfizer. Pfizer provided the Zoloft and placebo pills used in the study, but did not provide other support for the study and was not involved in the design or implementation of the study. Walkup and colleagues report receiving various fees and research support from various pharmaceutical companies.

The study findings, and the Emslie editorial, appear in the Dec. 25 issue of the New England Journal of Medicine.