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Treatment of post-traumatic stress disorder with venlafaxine extended release: a 6-month, randomized, controlled trial

Treatment of post-traumatic stress disorder with venlafaxine extended release: a 6-month, randomized, controlled trial
Treatment of post-traumatic stress disorder with venlafaxine extended release: a 6-month, randomized, controlled trial
Context No large-scale posttraumatic stress disorder drug trials have been conducted to evaluate treatment effects beyond 12 weeks outside of those with selective serotonin reuptake inhibitors.
Objective To evaluate the efficacy of venlafaxine extended release (ER), a serotonin norepinephrine reuptake inhibitor, in posttraumatic stress disorder.
Design 6-month, double-blind, placebo-controlled trial.
Setting International study at 56 sites.
Patients Adult outpatients (N = 329) with a primary diagnosis of posttraumatic stress disorder as defined in the DSM-IV, symptoms for 6 months or longer, and a 17-item Clinician-Administered Posttraumatic Stress Disorder Scale score of 60 or higher.
Intervention Patients randomly assigned to receive flexible doses of venlafaxine ER (37.5-300 mg/d) or placebo for 24 weeks.
Main Outcome Measures Primary measure was the change from baseline in the Clinician-Administered Posttraumatic Stress Disorder Scale score. Secondary measures included remission, defined as a Clinician-Administered Posttraumatic Stress Disorder Scale score of 20 or lower, and changes in symptom cluster scores, frequency of remission, and time to remission. Measures of stress vulnerability, resilience, depression, quality of life, functioning, and global illness severity were also taken.
Results Mean changes from baseline in Clinician-Administered Posttraumatic Stress Disorder Scale total scores at end point were –51.7 for venlafaxine ER and –43.9 for placebo (P = .006). Improvement was significantly greater for the venlafaxine ER group than for the placebo group in cluster scores for reexperiencing (P = .008) and avoidance/numbing (P = .006), but not for hyperarousal. Remission rates were 50.9% for venlafaxine ER and 37.5% for placebo (P = .01). The venlafaxine ER group also showed significantly greater improvement at end point than the placebo group (P<.05) on all other reported outcome measures. The mean maximum daily dose of venlafaxine ER was 221.5 mg/d. Withdrawal rates were similar between groups with no significant difference in dropouts attributable to adverse events.
Conclusion In this study, venlafaxine ER was effective and well tolerated in short-term and continuation treatment of patients with posttraumatic stress disorder.
0003-990X
1158-1165
Davidson, Jonathan
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Baldwin, David
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Stein, Dan J.
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Kuper, Enrique
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Benattia, Isma
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Ahmed, Saeed
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Pedersen, Ron
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Musgnung, Jeff
0ce68b11-7355-4700-a9f4-10eeb0b174dc
Davidson, Jonathan
3ee9aa6d-9112-4e56-950a-74869aebfb24
Baldwin, David
1beaa192-0ef1-4914-897a-3a49fc2ed15e
Stein, Dan J.
07cf0cbd-837d-49ac-aceb-1c393a2f3e00
Kuper, Enrique
2c8f9e3d-0dae-4c02-a3c6-4ed150e2df28
Benattia, Isma
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Ahmed, Saeed
0984c12f-c4f6-46c2-bbe3-b3c45eef17c6
Pedersen, Ron
bb3776f0-8051-498e-96b3-940642e3ba5b
Musgnung, Jeff
0ce68b11-7355-4700-a9f4-10eeb0b174dc

Davidson, Jonathan, Baldwin, David, Stein, Dan J., Kuper, Enrique, Benattia, Isma, Ahmed, Saeed, Pedersen, Ron and Musgnung, Jeff (2006) Treatment of post-traumatic stress disorder with venlafaxine extended release: a 6-month, randomized, controlled trial. Archives of General Psychiatry, 63 (10), 1158-1165. (doi:10.1001/archpsyc.63.10.1158).

Record type: Article

Abstract

Context No large-scale posttraumatic stress disorder drug trials have been conducted to evaluate treatment effects beyond 12 weeks outside of those with selective serotonin reuptake inhibitors.
Objective To evaluate the efficacy of venlafaxine extended release (ER), a serotonin norepinephrine reuptake inhibitor, in posttraumatic stress disorder.
Design 6-month, double-blind, placebo-controlled trial.
Setting International study at 56 sites.
Patients Adult outpatients (N = 329) with a primary diagnosis of posttraumatic stress disorder as defined in the DSM-IV, symptoms for 6 months or longer, and a 17-item Clinician-Administered Posttraumatic Stress Disorder Scale score of 60 or higher.
Intervention Patients randomly assigned to receive flexible doses of venlafaxine ER (37.5-300 mg/d) or placebo for 24 weeks.
Main Outcome Measures Primary measure was the change from baseline in the Clinician-Administered Posttraumatic Stress Disorder Scale score. Secondary measures included remission, defined as a Clinician-Administered Posttraumatic Stress Disorder Scale score of 20 or lower, and changes in symptom cluster scores, frequency of remission, and time to remission. Measures of stress vulnerability, resilience, depression, quality of life, functioning, and global illness severity were also taken.
Results Mean changes from baseline in Clinician-Administered Posttraumatic Stress Disorder Scale total scores at end point were –51.7 for venlafaxine ER and –43.9 for placebo (P = .006). Improvement was significantly greater for the venlafaxine ER group than for the placebo group in cluster scores for reexperiencing (P = .008) and avoidance/numbing (P = .006), but not for hyperarousal. Remission rates were 50.9% for venlafaxine ER and 37.5% for placebo (P = .01). The venlafaxine ER group also showed significantly greater improvement at end point than the placebo group (P<.05) on all other reported outcome measures. The mean maximum daily dose of venlafaxine ER was 221.5 mg/d. Withdrawal rates were similar between groups with no significant difference in dropouts attributable to adverse events.
Conclusion In this study, venlafaxine ER was effective and well tolerated in short-term and continuation treatment of patients with posttraumatic stress disorder.

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Published date: October 2006

Identifiers

Local EPrints ID: 40587
URI: http://eprints.soton.ac.uk/id/eprint/40587
ISSN: 0003-990X
PURE UUID: 6844288c-486a-4b61-b189-60a04a4602c0
ORCID for David Baldwin: ORCID iD orcid.org/0000-0003-3343-0907

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Date deposited: 07 Jul 2006
Last modified: 16 Mar 2024 02:48

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Contributors

Author: Jonathan Davidson
Author: David Baldwin ORCID iD
Author: Dan J. Stein
Author: Enrique Kuper
Author: Isma Benattia
Author: Saeed Ahmed
Author: Ron Pedersen
Author: Jeff Musgnung

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