1. Pregabalin for treatment of generalized anxiety disorder: a 4-week, multicenter, double-blind, placebo-controlled trial of pregabalin and alprazolam.
- Author
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Rickels K, Pollack MH, Feltner DE, Lydiard RB, Zimbroff DL, Bielski RJ, Tobias K, Brock JD, Zornberg GL, and Pande AC
- Subjects
- Adult, Alprazolam adverse effects, Alprazolam therapeutic use, Anti-Anxiety Agents adverse effects, Anti-Anxiety Agents therapeutic use, Anticonvulsants adverse effects, Anxiety Disorders diagnosis, Anxiety Disorders psychology, Dizziness chemically induced, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Placebos, Pregabalin, Psychiatric Status Rating Scales, Sleep drug effects, Treatment Outcome, Xerostomia chemically induced, gamma-Aminobutyric Acid adverse effects, gamma-Aminobutyric Acid therapeutic use, Anticonvulsants therapeutic use, Anxiety Disorders drug therapy, gamma-Aminobutyric Acid analogs & derivatives
- Abstract
Background: Pregabalin inhibits release of excess excitatory neurotransmitters, presumably by binding to the alpha2-delta subunit protein of widely distributed voltage-dependent calcium channels in the brain and spinal cord., Objective: To assess the anxiolytic efficacy of pregabalin in patients with generalized anxiety disorder., Design: Double-blind, placebo-controlled, active-comparator trial. Patients were randomized to 4 weeks of treatment with pregabalin, 300 mg/d (n = 91), 450 mg/d (n = 90), or 600 mg/d (n = 89); alprazolam, 1.5 mg/d (n = 93); or placebo (n = 91)., Setting: Psychiatry research and clinic settings., Patients: Outpatients meeting the DSM-IV criteria for generalized anxiety disorder, with a baseline Hamilton Anxiety Rating Scale (HAM-A) total score of 20 or greater., Main Outcome Measures: Change from baseline to end point in total HAM-A score in the pregabalin and alprazolam groups compared with the placebo group. The end point response criterion was 50% or greater reduction in the HAM-A total score., Results: Pregabalin and alprazolam produced a significantly greater reduction in mean +/- SE HAM-A total score at last-observation-carried-forward end point compared with placebo (-8.4 +/- 0.8): pregabalin, 300 mg (-12.2 +/- 0.8, P<.001), 450 mg (-11.0 +/- 0.8, P = .02), and 600 mg (-11.8 +/- 0.8, P = .002), and alprazolam (-10.9 +/- 0.8, P = .02). By week 1 and at last-observation-carried-forward end point, the 3 pregabalin groups and the alprazolam group had significantly (P<.01) improved HAM-A psychic anxiety symptoms compared with the placebo group. Compared with the placebo group, HAM-A somatic anxiety symptoms were also significantly (P<.02) improved by the 300- and 600-mg pregabalin groups, but not by the 450-mg pregabalin (week 1, P = .06; week 4, P = .32) and the alprazolam groups (week 1, P = .21; week 4, P = .15). Of the 5 treatment groups, the 300-mg pregabalin group was the only medication group that differed statistically in global improvement at treatment end point not only from the placebo group but also from the alprazolam group., Conclusion: Pregabalin was significantly more efficacious than placebo for the treatment of psychic and somatic symptoms of generalized anxiety disorder and was well tolerated by most study patients.
- Published
- 2005
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