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A 6-Month Randomized Controlled Trial

Alan J. Gelenberg, MD; R. Bruce Lydiard, PhD, MD; Richard L. Rudolph, MD; Loren Aguiar, MD; J. Thomas Haskins, PhD; Eliseo Salinas, MD

JAMA. 2000;283:3082-3088.

Context  Generalized anxiety disorder (GAD) is a chronic disorder that is associated with debilitating psychic and somatic symptoms. Venlafaxine extended-release (XR) capsules have been shown to be effective in short-term treatment of patients with GAD without major depressive disorder (MDD), but long-term data are needed to establish whether this agent confers persistent benefits.

Objective  To compare the 6-month efficacy and safety of a flexible dosage of venlafaxine XR in outpatients with GAD without associated MDD.

Design  Six-month, randomized, double-blind, placebo-controlled, parallel-group trial conducted May 1996 to October 1997.

Setting  Fourteen outpatient clinics and private psychiatric practices in the United States.

Participants  A total of 251 outpatients aged 18 years or older who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for GAD, had sufficient symptoms to require treatment, and did not have coexisting MDD.

Interventions  Participants were randomly assigned to receive either placebo (n=127) or venlafaxine XR (75, 150, or 225 mg/d, as required to control symptoms; n=124) for 28 weeks.

Main Outcome Measures  Changes from baseline in the Hamilton Rating Scale for Anxiety (HAM-A) total score, the HAM-A psychic anxiety factor score, and the Clinical Global Impressions (CGI) scale Severity of Illness and Global Improvement scores, compared by intervention group.

Results  During weeks 6 through 28, response rates in the venlafaxine XR group were 69% or higher compared with rates of 42% to 46% in the placebo group (P<.001). By an evaluable-patient analysis, venlafaxine XR compared with placebo significantly improved anxiety scores from week 1 or 2 through week 28 on all primary efficacy measures, including the HAM-A total (P<.001), the HAM-A psychic anxiety factor (P<.001), and the CGI scale scores (P<.001). Adjusted mean changes from baseline to week 28 using last-observation-carried-forward methods were for HAM-A, venlafaxine XR -13.4, placebo -8.7 (P<.001); for HAM-A psychic anxiety score, venlafaxine XR -7.4, placebo -4.2 (P<.001); and for CGI-Improvement, venlafaxine XR 2.2, placebo 3.0 (P<.001). The most common treatment-emergent adverse event was nausea, followed by somnolence and dry mouth.

Conclusions  This study is the first placebo-controlled demonstration of the long-term efficacy of any drug class in treating outpatients with DSM-IV–diagnosed GAD. Venlafaxine XR is an effective, rapidly acting, safe, once-daily agent for both the short- and long-term treatment of anxiety and may provide an important alternative to currently available anxiolytics.

Author Affiliations: University Medical Center, Arizona Health Sciences Center, Tucson (Dr Gelenberg), Medical University of South Carolina, Charleston (Dr Lydiard), and Wyeth-Ayerst Research, Philadelphia, Pa (Drs Rudolph, Aguiar, Haskins, and Salinas).

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