Duloxetine Treatment for Role Functioning Improvement in Generalized Anxiety Disorder: Three Independent Studies

Jean Endicott, Ph.D.; James M. Russell, M.D.; Joel Raskin, M.D.; Michael J. Detke, M.D., Ph.D.; Janelle Erickson, Ph.D.; Susan G. Ball, Ph.D.; Martin Marciniak, Ph.D.; and Ralph W. Swindle, Ph.D.

Objective: Generalized anxiety disorder (GAD) is associated with impaired role functioning and diminished well-being. The present work examined the efficacy of duloxetine treatment for improving functional outcomes for patients with GAD in 3 independent clinical studies.

Method: Studies were randomized, double-blind, placebo-controlled multicenter trials conducted in adult outpatients with DSM-IV-defined GAD. One study compared 9-week fixed-dose treatment with duloxetine 60 or 120 mg (N = 168 and N = 170, respectively) with placebo (N = 175). The other 2 studies compared 10-week flexible-dose treatment with duloxetine 60-120 mg (study 2, N = 168; study 3, N = 162) with placebo (study 2, N = 159; study 3, N = 161). The main functional outcome measure for each study was the Sheehan Disability Scale (SDS). Additional measures were the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form and the European Quality of Life 5 Dimensions. The 3 studies were conducted in the time period from June 2004 to November 2005.

Results: Duloxetine-treated patients improved significantly more than placebo-treated patients on SDS global functioning (study 1, p <= .001; studies 2 and 3, p <= .01) and SDS work, social life, and family/home responsibility scores (p values range from <= .05 to <= .001). At treatment endpoint, a greater percentage of duloxetine-treated patients had obtained SDS global functioning scores in the normative range than placebo-treated patients (p values range from < = .05 to <= .001). Duloxetine-treated patients also reported greater increases in quality of life, well-being, and health compared with the placebo group on the other functional measures (p values range from <= .05 to <= .001).

Conclusions: Duloxetine consistently reduced role functioning disabilities associated with GAD and enhanced patients' quality of life and well-being in 3 independent clinical studies.

Clinical Trials Registration: ClinicalTrials.gov identifiers NCT00122824 (study 1) and NCT00122850 (study 3). Study 2 was completed prior to the requirement to post trials at initiation and does not have a registration number.

(J Clin Psychiatry 2007;68:518-524)

Received Sept. 20, 2006; accepted Dec. 13, 2006. From New York State Psychiatric Institute and Columbia School of Medicine, New York (Dr. Endicott); Lilly Research Laboratories (Drs. Russell, Raskin, Detke, Erickson, Ball, Marciniak, and Swindle) and Indiana University School of Medicine (Drs. Detke and Ball), Indianapolis; and McLean Hospital and Harvard Medical School, Boston, Mass. (Dr. Detke).

The research was funded by Eli Lilly and Company, Indianapolis, Ind., and Boehringer Ingelheim, Wiesbaden, Germany.

Acknowledgments are listed at the end of the article.

Dr. Endicott has received research support from or has served as a consultant/advisory board member for Abbott, AstraZeneca, Berlex, Bristol-Myers Squibb, Cyberonics, Eli Lilly, GlaxoSmithKline, Interneuron, Merck, Parke-Davis, Novartis, Otsuka, Janssen, Pfizer, Sanofi-Synthelabo, Upjohn, and Wyeth-Ayerst. Drs. Russell, Raskin, Detke, Erickson, Ball, Marciniak, and Swindle are employees of and shareholders in Eli Lilly. Dr. Swindle is a member of the speakers/advisory board for Eli Lilly.

Corresponding author and reprints: Jean Endicott, Ph.D., New York State Psychiatric Institute, Columbia School of Medicine, NYSPI-Unit 123, 1051 Riverside Dr., New York, NY 10032 (e-mail: je10@columbia.edu).