ABSTRACT

Major depression (MD) is one of the most disabling and common psychiatric disorders. Recent data estimate a lifetime prevalence of MDD at 16.6% and the 1-year prevalence at 6.7% (Kessler et al. 2005; Sadock and Sadock 2005; De Berardis et al. 2008a). MDD is a leading cause of premature death and ongoing disability (Lopez et al. 2006). Psychopharmacological treatments include a number of antidepressant drugs, but over 60% of treated patients respond unsatisfactorily, and almost 20% of patients become refractory to the treatments (Fava 2003; Little 2009;

25.1 Introduction .......................................................................................................................... 325 25.2 Pharmacological Characteristics of Agomelatine ................................................................ 326 25.3 Agomelatine Treatment of Major Depression ....................................................................... 327

25.3.1 Acute Phase Trials with Agomelatine versus Placebo ........................................... 327 25.3.2 Antidepressant Efcacy in Active Comparator Trials ........................................... 327 25.3.3 Anhedonia in Major Depression and Response to Agomelatine ........................... 330 25.3.4 Sleep in Major Depressive Disorder ...................................................................... 330 25.3.5 Sexual Function ..................................................................................................... 330 25.3.6 Anxiety Symptoms within Depression .................................................................. 331 25.3.7 Discontinuation Symptoms .................................................................................... 331 25.3.8 Responders, Remitters, and Relapse Prevention .................................................... 331 25.3.9 Serum Transaminases ............................................................................................ 331 25.3.10 Limitations of Agomelatine Trials in Major Depressive Disorder ........................ 332

25.4 Agomelatine Treatment of Anxiety Disorders ..................................................................... 332 25.4.1 Generalized Anxiety Disorder ............................................................................... 332 25.4.2 Other Anxiety Disorders ........................................................................................ 333

25.5 Conclusions ........................................................................................................................... 333 References ...................................................................................................................................... 334

Parker and Brotchie 2010). Patients who respond satisfactory to the treatments benet from reduced suicide rates, increased participation in the workforce, reduced secondary alcohol or other substance misuse, and decreased risk of cardiovascular disease (Hall et al. 2003; Hickie 2007). In clinical studies, patients with a reduction of 50% or more on the Hamilton Depression rating scale (HAM-D) total score at endpoint are considered responders to treatment; remission, which represents complete or near-complete symptom resolution including resolution of functional impairment, is commonly dened as HAM-D total score of ≤7 (De Berardis et al. 2008b).