Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)

Major Depressive Disorder Clinical Trial

Official title:

A 8-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of Agomelatine 0.5 mg and 1 mg Sublingual Tablets Administered Once Daily in Patients With Major Depressive Disorder (MDD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110902
• Other study ID #: CAGO178C2302
• Status: Completed
• Phase: Phase 3
• Start date: May 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
• Current episode =4 weeks.
• CGI-Severity score =4 at Screening and Baseline.

Exclusion Criteria:

• History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder.
• Any other current Axis I disorder other than MDD which is the focus of treatment.
• Substance or alcohol abuse in the last 30 days, dependence in the last 6 months.
• Concomitant psychotropic medication, including herbal preparations and melatonin.
• Psychotherapy of any type.
• Prior exposure to agomelatine.
• Female patients of childbearing potential who are not using effective contraception. Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Agomelatine (AGO178C)

• Placebo

Locations

Country	Name	City	State
Puerto Rico	Caribbean Research and Education Center	Bayamon
Puerto Rico	Dharma Institute and Research Center	San Juan
United States	ICSL Clinical Studies	Altamonte Springs	Florida
United States	Emory University	Atlanta	Georgia
United States	FutureSearch Trials	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	University of Alabama at Birmingham, Department of Psychiatry	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	Boston Clinical Trials	Brighton	Massachusetts
United States	Social Psychiatric Research Institute	Brooklyn	New York
United States	Neurobehavioral Clinical Research	Canton	Ohio
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Arocha Research Center	Coral Gables	Florida
United States	ATP Clinical Research	Costa Mesa	California
United States	Valley Clinical Research	El Centro	California
United States	Willamette Valley Clinical Studies	Eugene	Oregon
United States	Deaconess Clinic	Evansville	Indiana
United States	Collaborative Neuroscience Network	Garden Grove	California
United States	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois
United States	Claghorn-Lesem Research Clinic, Inc.	Houston	Texas
United States	Joliet Center for Clinical Research	Joliet	Illinois
United States	Premier Psychiatry Group, LLC	Lincoln	Nebraska
United States	CNS Healthcare	Memphis	Tennessee
United States	Research Strategies	Memphis	Tennessee
United States	Innova Clinical Trials	Miami	Florida
United States	Eastside Comprehensive Medical Service	New York	New York
United States	Medical University of South Carolina	North Charleston	South Carolina
United States	SP Research	Oklahoma City	Oklahoma
United States	University of California, Irvine Medical Center	Orange	California
United States	CNS Clinical Trials	Park Ridge	Illinois
United States	CRI Worldwide, LLC - Kirkbride Division	Philadelphia	Pennsylvania
United States	Pharmasite Research	Pikesville	Maryland
United States	Summit Research Network	Portland	Oregon
United States	Anderson Clinical Research	Redlands	California
United States	Mercy Health Research	Saint Louis	Missouri
United States	University of Utah, Department of Psychiatry	Salt Lake City	Utah
United States	Affiliated Research Institute	San Diego	California
United States	Summit Research	Seattle	Washington
United States	California Neuroscience Research Medical Group, Inc.	Sherman Oaks	California
United States	Miami Research Associates	South Miami	Florida
United States	Viking Clinical Research	Temecula	California
United States	Neurology & Neuroscience Center of Ohio	Toledo	Ohio
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	CRI Worldwide, LLC - Lourdes Division	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale		Baseline and 8 weeks
Secondary	Effect on subjective sleep, as measured by the score of the Leeds Sleep Evaluation Questionnaire (LSEQ) domain "quality of sleep" at Week 8		8 weeks
Secondary	Proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the Baseline clinician-rated HAM-D total score at Week 8 endpoint		8 weeks
Secondary	Proportion of patients who demonstrate clinical improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale		8 weeks
Secondary	Proportion of patients who achieve remission		8 weeks
Secondary	Safety and tolerability by adverse events and serious adverse events, and assessment of suicidal ideation and behavior by Columbia Suicide Severity Rating Scale.		8 weeks

External Links

•   Click here for more information about this study:
•   Results for CAGO178C2302 from the Novartis Clinical Trials website