Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)
Summary
The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Major Depressive Disorder
Intervention
Agomelatine (AGO178C), Agomelatine (AGO178C), Placebo
Location
University of Alabama at Birmingham, Department of Psychiatry
Birmingham
Alabama
United States
35294
Status
Recruiting
Source
Novartis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01110902
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Bipolar Disorder
A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.
Trazodone
A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309)
Depressive Disorder, Major
Marked depression appearing in the involution period and characterized by hallucinations, delusions, paranoia, and agitation.
Depressive Disorder
An affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities. The mood disturbance is prominent and relatively persistent.
Depression
Depressive states usually of moderate intensity in contrast with major depression present in neurotic and psychotic disorders.
Clinical Trials
The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder over a 52-we...
This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients will under...
This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receiv...
Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blin...
An 8 Week Study Of Depression In Adults Diagnosed With Major Depressive Disorder
A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD)
PubMed Articles
Efficacy of agomelatine in major depressive disorder: meta-analysis and appraisal.
Agomelatine is the first approved antidepressant that mediates its activity through the melatoninergic pathway rather than the monoaminergic system. This meta-analysis aims to summarize an up-to-date...
{blacktriangledown}Agomelatine for major depressive episodes.
black triangle downAgomelatine (Valdoxan - Servier) is an antidepressant licensed for treating patients with major depressive episodes. The drug company's website for agomelatine states that the drug...
QTc Prolongation During Treatment with Agomelatine.
A 58 years old woman with a depression showed a QTc prolongation during treatment with agomelatine which was fully reversible after stopping administration. QTc prolongation during antidepressant trea...
One of the ongoing clinical challenges associated with the management of major depressive disorder is the fact that many patients do not achieve complete remission and even fewer patients remain in re...
The objective of this international, 8-week, randomized, double-blind study was to show the superiority of the antidepressant efficacy of agomelatine, the first MT1/MT2 receptor agonist and 5-HT2C rec...
