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Duloxetine in the prevention of relapse of major depressive disorder

Double-blind placebo-controlled study

Lilly Research Centre, Windlesham, and Gordon Hospital, London, UK

INMACULADA GILABERTE, MD, PhD

Medical Department, Lilly Spain, Alcobendas, Spain

FUJUN WANG, PhD, CURTIS G. WILTSE, PhD, STACY A. HUCKINS, BS and JEFFREY W. CLEMENS, PhD

Lilly Research Laboratories, Indianapolis, Indiana, USA

STUART A. MONTGOMERY, MD

Imperial College School of Medicine, London, UK

ANGEL L. MONTEJO, MD, PhD

University Hospital of Salamanca, Psychiatric Teaching Area, School of Medicine, University of Salamanca, Salamanca, Spain

MICHAEL J. DETKE, MD, PhD

Lilly Research Laboratories, Indianapolis and Department of Psychiatry, Indiana University School of Medicine, Indianapolis, Indiana, Department of Psychiatry, McLean Hospital, Belmont, Massachusetts and Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA

Correspondence: Dr David G. Perahia, Lilly Research Centre, Sunninghill Road, Windlesham, Surrey GU20 6PH, UK. Tel: +44 (0)1276 483 000; fax: +44 (0)1276 483 711; e-mail: d.perahia{at}lilly.com

Declaration of interest D.G.P., I.G., F.W., C.G.W., S.A.H., J.W.C. and M.J.D. are employees and stockholders of Eli Lilly and Company, Indianapolis, Indiana, USA. S.A.M. and A.L.M. have served as paid consultants for Eli Lilly and Company.

Background Relapse rates may be as high as 50% in people with major depressive disorder (MDD) previously treated to remission.

Aims Duloxetine, an inhibitor of serotonin and noradrenaline reuptake that is licensed in Europe, the USA and elsewhere for the treatment of depressive episodes, was evaluated with regard to its efficacy, safety and tolerabilityin the prevention of relapse of MDD.

Method Adult out-patients with MDD received duloxetine (60 mg daily) for 12 weeks (n=533). Patients who responded to the drug were then randomised to duloxetine(60 mg daily)(n=136) or orplacebo placebo (n=142) for 26 weeks. The primary measure of efficacy was time to relapse.

Results Patients who received duloxetine (60 mg daily) experienced significantly longer times to relapse of MDD, and better efficacy, global well-being, and quality-of-life outcomes compared with patients who received placebo. It should be noted that adverse events which occur in discontinuation may mimic some signs of depressive relapse, and were not specifically elicited in this study.

Conclusions Duloxetine (60 mg daily) is effective in the prevention of relapse of MDD during continuation treatment.

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