Source: Graefes Arch Clin Exp Ophthalmol  |  Posted 6 years ago

By Bonnie Darves

SEATTLE, WA -- March 22, 2005 -- Tiagabine might help reduce relapses in patients with social anxiety disorder (SAD), phase 2 results suggest, but more data is needed before the drug can be considered a viable therapeutic option, according to the study's chief author.

Philip Ninan, MD, professor of psychiatry, Emory University, Atlanta, Georgia, United States, said, "We did see some efficacy, but the [participant] numbers were small and there were retention issues."

"Would I use this as a first-line treatment?" he asked. "Probably not, because we need more data."

As a positive, Dr. Ninan noted that patients who took the drug did not experience weight gain, which could ultimately give tiagabine an advantage over selective serotonin reuptake inhibitors, which have been associated with weight gain in many patients.

Dr. Ninan presented results of a randomised, double-blind trial of tiagabine in patients with SAD here on March 20[^]th[] at the Anxiety Disorders Association of America 25[^]th[] Annual Conference. The study was the first to look at the drug's efficacy in this population.

The trial had two phases. The initial 12-week open-label treatment period involved 63 participants. Those deemed responders (n=22) entered the phase 2, placebo-controlled phase; 17 patients completed this phase.

Participants in the drug arm had a decline of 0.7 in their Clinical Global Impression Inventory scores, compared to those on placebo, and improvements of -6.3 and -1.7, respectively, on the Social Phobia Inventory Sheehan Disability scales, Dr. Ninan said.

The study was sponsored by Cephalon, Inc.

[Presentation title: Relapse Prevention Study of Tiagabine in Patients With Social Anxiety Disorder. Poster 106]