Placebo-controlled trial of agomelatine in the treatment of major depressive disorder

• Published in: European neuropsychopharmacology Vol. 16; no. 2; pp. 93 - 100
• Main Authors: Kennedy, S.H., Emsley, R.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01-02-2006
• Subjects: Acetamides - adverse effects; Acetamides - therapeutic use; Adolescent; Adult; Aged; Agomelatine; Antidepressant; Depressive Disorder, Major - drug therapy; Depressive Disorder, Major - psychology; Double-Blind Method; Female; Humans; Hypnotics and Sedatives - adverse effects; Hypnotics and Sedatives - therapeutic use; Major depressive disorder; Male; Middle Aged; Placebo controlled; Psychiatric Status Rating Scales; Recurrence; Remission; Response rate; Treatment Outcome; Antidepressant; Response rate; Remission; Placebo controlled; Agomelatine; Major depressive disorder
• ISSN: 0924-977X; 1873-7862
• DOI: 10.1016/j.euroneuro.2005.09.002

The efficacy and safety of flexible dosing with the antidepressant agomelatine (25–50 mg/day) was evaluated in a 6-week, double-blind, randomized, placebo-controlled study involving 212 patients who met Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for major depressive disorder—current major depressive episode. Patients receiving agomelatine (25 mg and 50 mg/day) had a significantly lower mean Hamilton Rating Scale for Depression (HAM-D) score at endpoint compared with those who received placebo (14.1±7.7 vs. 16.5±7.4, p=0.026). Agomelatine significantly improved the response rate (49.1%; p=0.03), time to first response (p=0.032), and Clinical Global Impression-Severity of Illness score (p=0.017), compared with placebo. These results were confirmed in a subgroup of patients with greater symptom severity. Agomelatine 50 mg also appeared to be effective and well tolerated in patients who failed to show improvement after 2 weeks on a dose of 25 mg/day. These results support the prescription of agomelatine 25 mg as the usual therapeutic dose, and suggest that increasing the dose to 50 mg may be beneficial for some patients without reducing tolerability.