1. Time to relapse after 6 and 12 months' treatment of generalized anxiety disorder with venlafaxine extended release.
- Author
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Rickels K, Etemad B, Khalid-Khan S, Lohoff FW, Rynn MA, and Gallop RJ
- Subjects
- Adult, Aged, Anti-Anxiety Agents adverse effects, Anxiety Disorders diagnosis, Anxiety Disorders psychology, Cyclohexanols adverse effects, Delayed-Action Preparations, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Secondary Prevention, Selective Serotonin Reuptake Inhibitors adverse effects, Time Factors, Treatment Outcome, Venlafaxine Hydrochloride, Anti-Anxiety Agents administration & dosage, Anxiety Disorders drug therapy, Anxiety Disorders prevention & control, Cyclohexanols administration & dosage, Selective Serotonin Reuptake Inhibitors administration & dosage
- Abstract
Context: Generalized anxiety disorder (GAD) is a chronic disorder in need of reliable data to guide long-term treatment., Objectives: To assess the benefits of 6 and 12 months' treatment of GAD with venlafaxine hydrochloride extended release (XR) in patients who improved after 6 months' open-label venlafaxine XR treatment., Design: After 6 months' open-label venlafaxine XR treatment, improved patients were randomized to venlafaxine XR or placebo for 6 months. All venlafaxine XR patients still in the study at 12 months were randomized to receive venlafaxine XR or placebo, and all placebo patients continued taking placebo for another 6 months., Setting: One urban site (5 locations)., Patients: Of 268 patients with a diagnosis of GAD entering the open-label venlafaxine XR treatment phase, 158 (59.0%) completed 6 months, and 136 (50.7%) entered relapse phase 2 (6-12 months). Fifty-nine (43.4%) of 136 patients entered phase 3 (12-18 months)., Intervention: Six months' open-label treatment with venlafaxine XR, followed by double-blind venlafaxine XR or placebo for 2 relapse phases, each lasting 6 months., Main Outcome Measures: Time to relapse while receiving venlafaxine XR or placebo after 6 and after 12 months of treatment. Relapse was strictly defined to safeguard against assigning patients with venlafaxine XR discontinuation symptoms or temporary anxiety increase as relapse., Results: For objective 1, relapse rates in phase 2 (months 6-12) were 9.8% on venlafaxine XR and 53.7% on placebo (P < .001). For objective 2, relapse rates after 12 months on placebo (32.4%) were lower than after 6 months on venlafaxine XR (53.7%) (P < .03)., Conclusions: Treatment of GAD with an antidepressant should be continued for at least 12 months. Preliminary data demonstrate that improved patients who relapse while off their antianxiety medication after at least 6 months of treatment will again most likely respond to a second course of treatment with the same medication. Trial Registration clinicaltrials.gov Identifier: NCT00183274.
- Published
- 2010
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