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Improvement of psychic and somatic symptoms in adult patients with generalized anxiety disorder: examination from a duloxetine, venlafaxine extended-release and placebo-controlled trial

Published online by Cambridge University Press:  19 May 2008

H. Nicolini ,
D. Bakish ,
H. Duenas ,
M. Spann ,
J. Erickson ,
C. Hallberg ,
S. Ball ,
D. Sagman  and
J. M. Russell
H. Nicolini
Affiliation:
Grupo Medico Carracci, Mexico City, Mexico
D. Bakish*
Affiliation:
Ottawa Psychopharmacology Clinic, Ottawa, Canada
H. Duenas
Affiliation:
Eli Lilly and Company, Mexico DF, Mexico
M. Spann
Affiliation:
Lilly Research Laboratories, Indianapolis, IN, USA
J. Erickson
Affiliation:
Lilly Research Laboratories, Indianapolis, IN, USA
C. Hallberg
Affiliation:
Lilly Research Laboratories, Indianapolis, IN, USA
S. Ball
Affiliation:
Lilly Research Laboratories, Indianapolis, IN, USA Indiana University School of Medicine, Indianapolis, IN, USA
D. Sagman
Affiliation:
Eli Lilly and Company, Danforth, Toronto, Ontario, Canada
J. M. Russell
Affiliation:
Lilly Research Laboratories, Indianapolis, IN, USA
*
*Address for correspondence: D. Bakish, M.D., Ottawa Psychopharmacology Clinic, Suite 328, 1929 Russell Road Ottawa, Ontario K1G 4G3, Canada. (Email: dbakish@opctrials.com)
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Abstract

Background

This study examined the efficacy and tolerability of duloxetine and venlafaxine extended-release (XR) treatment for generalized anxiety disorder (GAD), with a secondary focus on psychic and somatic symptoms within GAD.

Method

The design was a 10-week, multi-center, double-blind placebo-controlled study of duloxetine (20 mg or 60–120 mg once daily) and venlafaxine XR (75–225 mg once daily) treatment. Efficacy was measured using the Hamilton Anxiety Rating Scale (HAMA), which includes psychic and somatic factor scores. Tolerability was measured by occurrence of treatment-emergent adverse events (TEAEs) and discontinuation rates.

Results

Adult out-patients (mean age 42.8 years; 57.1% women) with DSM-IV-defined GAD were randomly assigned to placebo (n=170), duloxetine 20 mg (n=84), duloxetine 60–120 mg (n=158) or venlafaxine XR 75–225 mg (n=169) treatment. Each of the three active treatment groups had significantly greater improvements on HAMA total score from baseline to endpoint compared with placebo (p=0.01–0.001). For the HAMA psychic factor score, both duloxetine treatment arms and venlafaxine XR demonstrated significantly greater improvement compared with placebo (p=0.01–0.001). For the HAMA somatic factor score, the mean improvement in the duloxetine 60–120 mg and venlafaxine XR groups was significantly greater than placebo (p⩽0.05 and p⩽0.01 respectively), whose mean improvement did not differ from the duloxetine 20 mg group (p=0.07). Groups did not differ in study discontinuation rate due to adverse events.

Conclusions

Duloxetine and venlafaxine treatment were each efficacious for improvement of core psychic anxiety symptoms and associated somatic symptoms for adults with GAD.

Keywords

Duloxetinegeneralized anxiety disorderpharmacotherapypsychic anxietysomatic anxietyvenlafaxine XR
Type
Original Articles
Information
Psychological Medicine , Volume 39 , Issue 2 , February 2009 , pp. 267 - 276
Copyright
Copyright © 2008 Cambridge University Press

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