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Arch Gen Psychiatry. 2010 Dec;67(12):1274-81. doi: 10.1001/archgenpsychiatry.2010.170.

Time to relapse after 6 and 12 months' treatment of generalized anxiety disorder with venlafaxine extended release.

Author information

  • 1Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, 19104, USA. krickels@mail.med.upenn.edu

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.

PMID:
21135327
[PubMed - indexed for MEDLINE]
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