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Venlafaxine Effective for Social Anxiety Disorder in Children and Adolescents: Presented at APA

By Charlene Laino

NEW YORK, NY -- May 10, 2004 -- Venlafaxine extended-release (ER) appears to be effective for children and adolescents with social anxiety disorder, a double-blind, placebo-controlled study suggests.

Karen A. Tourian, MD, Associate Director of Clinical Research and Development, Wyeth Pharmaceuticals, Philadelphia, Pennsylvania, presented the findings here on May 5^th at the American Psychiatric Association 157^th Annual Meeting.

The study enrolled 293 children and adolescents with a mean age of 13.6 years (range 8 to 17 years), who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for social anxiety disorder. Also, baseline scores on the Social Anxiety Scale for Children and Adolescents (SAS-CA) were 50 points or greater, and the patients had a clinical global impression-severity of illness score of at least 4.

Patients were randomized to venlafaxine ER, with the dosage adjusted to body weight, or placebo for 16 weeks. Just over half the children were girls, and about three-fourths were white.

According to Dr. Tourian, venlafaxine-treated patients showed significantly greater improvements than placebo-treated patients on the SAS-CA, the primary outcome measure. By week 16, SAS-CA scores had improved 22.5 points in the treated arm, compared with 14.9 points in the placebo group, she said. This was significant at the P <.001 level.

While there were no suicides or suicide attempts in either group, three patients in the venlafaxine arm showed signs of suicidal ideation, two during the double-blind period and one during the taper period. Also, physicians should be alert for signs of hostility in children and teens taking the drug, although this was not evident in this cohort, she said.

Nevertheless, "the drug works great," Dr. Tourian said. "By week 3, there is an improvement from placebo that only gets better over time."

Venlafaxine is not currently indicated for the treatment of social anxiety disorder in children and adolescents. The study was funded by Wyeth Research.


[Presentation title: "Venlafaxine extended release in children and adolescents with social anxiety disorder." Abstract # NR468]

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