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Controlled-Release Paroxetine Appears Effective, Safe in Patients with Social Anxiety Disorder

Controlled-release (CR) paroxetine appears to be well tolerated and effective in treating symptoms associated with social anxiety disorder.

The immediate-release formulation of paroxetine and other antidepressants appear to be effective in the treatment of social anxiety disorder (SAD). The current study evaluates the whether the CR formulation of paroxetine efficacy is similarly effective. Previous trials suggest that this formulation is associated with lower rates of treatment discontinuation due to adverse events.

Ulla Lepola, MD with the Department of Psychiatry, at the University of Helsinki, Helsinki, Finland, and colleagues studied an intent-to-treat population of 186 patients randomly assigned to paroxetine CR and 184 patients randomly assigned to placebo.

Patients had a primary diagnosis of SAD according to DSM-IV criteria and underwent a 1-week, single-blind, placebo run-in period. They then received paroxetine CR (flexible dose of 12.5-37.5 mg/day) or placebo for 12 weeks.

The primary efficacy measures were the change from baseline in Liebowitz Social Anxiety Scale (LSAS) score and the proportion of responders based on Clinical Global Impressions (CGI)-Global Improvement scale score. Data were collected from September 2001 to July 2002.

Statistically significant differences in favour of paroxetine CR compared with placebo were observed in the change from baseline to week 12 last-observation-carried-forward (LOCF) dataset in LSAS total score (difference = -13.33, P < .001). Likewise, in the CGI-Global Improvement responder analysis, 57.0% of patients treated with paroxetine CR achieved a very much improved or much improved response compared with only 30.4% of patients treated with placebo at week 12 LOCF (odds ratio = 3.12, P < .001).

Adverse events and dropout rates were low and similar in treatment and placebo groups, the researchers note.

"This study demonstrated that paroxetine CR effectively treated the symptoms and disability associated with social anxiety disorder," Dr. Lepola and colleagues conclude.

"In addition, paroxetine CR was well tolerated with few patients stopping treatment due to adverse events," they add. "This favorable tolerability profile may enable more patients to experience the benefits of effective therapy," they suggest.


J Clin Psychiatry 2004;65:222-229. "Controlled-Release Paroxetine in the Treatment of Patients With Social Anxiety Disorder"

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