Subjective effects of agomelatine in controlled induced anxiety in humans.

• Grant number: 12/17595-4
• Support Opportunities: Scholarships in Brazil - Post-Doctoral
• Start date: December 01, 2012
• End date: November 30, 2014
• Field of knowledge: Health Sciences - Medicine - Psychiatry
• Principal Investigator: José Alexandre de Souza Crippa
• Grantee: Mateus Machado Bergamaschi
• Host Institution: Faculdade de Medicina de Ribeirão Preto (FMRP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil

Abstract

Agomelatine, a new antidepressant, is a melantonine (MT1 and MT2) and serotonine (5-HT2C) receptor agonist. Clinical and animals studies' results suggest agomelatine may have anxiolytic property; however there is currently only 1 case report with social anxiety disorder (SAD) participant and therefore, agomelatine was never used in randomized, double-blind and placebo controlled study. Unlike other antidepressants, agomelatine does not induce increased body weight, sexual dysfunction or withdrawal syndrome. The objective of this study is to evaluate agomelatine's anxiolytic effect in healthy and SAD participants submitted to the Simulated Public Speaking Test (SPST) and Face Recognition. Agomelatine, citalopram, venlafaxine or placebo will be administered at a single dose in healthy (n = 14) and SAD participants (n = 14). All subjects will be submitted to SPST, followed by dynamic facial expressions test recognition of six basic emotions (happiness, sadness, disgust, anger, fear and surprise), in a double-blind procedure. We will apply the following self-assessments scales for subjective evaluation: 1. Analogue Mood Scale; 2. Bodily Symptom Scale; and 3. Self-evaluation at Public Speaking Scale. We will also monitor heart rate, blood pressure, skin conductance and number of spontaneous fluctuations of skin conductance. The results of this study will contribute to a better understanding of the potential therapeutic effects of agomelatine in anxiety and anxiety disorders. These findings may help subject's treatment for anxiety disorders.