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

Major Depressive Disorder Clinical Trial

Official title:

An 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: NCT01110889
• Other study ID #: CAGO178C2301
• Status: Completed
• Phase: Phase 3
• Start date: May 2010

Study information

• Verified date: February 2013
• 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: 582
• Est. primary completion date: July 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)

• Agomelatine (AGO178C)

• Placebo

Locations

Country	Name	City	State
Puerto Rico	Inspira Clinical Research	San Juan
United States	Neurological Associates Of Albany, P.C.	Albany	New York
United States	Albuquerque Neuroscience	Albuquerque	New Mexico
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	University of Colorado Denver	Aurora	Colorado
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Southwestern Research Institute	Beverly Hills	California
United States	Birmingham Psychiatry	Birmingham	Alabama
United States	Montefiore Medical Center	Bronx	New York
United States	Neurobehavioral Research Inc.	Cedarhurst	New York
United States	Rush University Medical Center	Chicago	Illinois
United States	The Ohio State University - Harding Hospital	Columbus	Ohio
United States	FutureSearch Trials of Dallas	Dallas	Texas
United States	KRK Medical Research	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Western Affiliated Research Institute	Denver	Colorado
United States	InSite Clinical Research	DeSoto	Texas
United States	Mountain West Clinical Trials	Eagle	Idaho
United States	Pharmacology Research Institute	Encino	California
United States	Odyssey Research Services	Fargo	North Dakota
United States	Psychiatric Consultants	Franklin	Tennessee
United States	Mood & Anxiety Research	Fresno	California
United States	Comprehensive Psychiatric Associates	Gladstone	Missouri
United States	Clinical Research Institute of South Florida	Hialeah	Florida
United States	Hawaii Clinical Research Center	Honolulu	Hawaii
United States	Texas Center for Drug Development	Houston	Texas
United States	Florida Clinical Research Center LLC	Maitland	Florida
United States	Northwest Behavioral Research Center	Marietta	Georgia
United States	Sunstone Medical Research, LLC	Medford	Oregon
United States	Clinical Trials Management	Metairie	Louisiana
United States	Excell Research, Inc	Oceanside	California
United States	Cutting Edge Research	Oklahoma City	Oklahoma
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	CNS Healthcare	Orlando	Florida
United States	Psychiatric Associates	Overland Park	Kansas
United States	Broward Research Group	Pembroke Pines	Florida
United States	Cnri-La, Llc	Pico Rivera	California
United States	Quantum Lab. N. Broward Memory Disorder Center	Pompano Beach	Florida
United States	CTT Clinical Trials Technology	Prairie Village	Kansas
United States	Psychopharmacology Research Association of Princeton	Princeton	New Jersey
United States	Alliance Research Group, LLC	Richmond	Virginia
United States	Finger Lakes Clinical Research	Rochester	New York
United States	CNRI San Diego	San Diego	California
United States	University of California San Diego Medical Center	San Diego	California
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Mount Auburn Medical Associates	Watertown	Massachusetts
United States	Coastal Research Associates	Weymouth	Massachusetts

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:
•   https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6663