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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01110902

Collaborator

(none)

589

Enrollment

Locations

Arms

Duration (Months)

13.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Agomelatine (AGO178C) Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

589 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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)

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AGO178C 0.5 mg /day	Drug: Agomelatine (AGO178C)
Experimental: AGO178C 1 mg / day	Drug: Agomelatine (AGO178C)
Placebo Comparator: Placebo	Drug: Placebo

Arm

Intervention/Treatment

Experimental: AGO178C 0.5 mg /day

Drug: Agomelatine (AGO178C)

Experimental: AGO178C 1 mg / day

Drug: Agomelatine (AGO178C)

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale [Baseline and 8 weeks]

Secondary Outcome Measures

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]
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]
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]
Proportion of patients who achieve remission [8 weeks]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham, Department of Psychiatry	Birmingham	Alabama	United States	35294
2	ATP Clinical Research	Costa Mesa	California	United States	92626
3	Valley Clinical Research	El Centro	California	United States	92243
4	Collaborative Neuroscience Network	Garden Grove	California	United States	92845
5	University of California, Irvine Medical Center	Orange	California	United States	92868
6	Anderson Clinical Research	Redlands	California	United States	92374
7	Affiliated Research Institute	San Diego	California	United States	92108
8	California Neuroscience Research Medical Group, Inc.	Sherman Oaks	California	United States	91403
9	Viking Clinical Research	Temecula	California	United States	92591
10	ICSL Clinical Studies	Altamonte Springs	Florida	United States	32701
11	Florida Clinical Research Center, LLC	Bradenton	Florida	United States	34208
12	Arocha Research Center	Coral Gables	Florida	United States	33134
13	Innova Clinical Trials	Miami	Florida	United States	33145
14	Miami Research Associates	South Miami	Florida	United States	33143
15	Emory University	Atlanta	Georgia	United States	30306
16	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois	United States	60169
17	Joliet Center for Clinical Research	Joliet	Illinois	United States	60435
18	CNS Clinical Trials	Park Ridge	Illinois	United States	60068
19	Deaconess Clinic	Evansville	Indiana	United States	47713
20	Heartland Research Associates, LLC	Wichita	Kansas	United States	67207
21	Pharmasite Research	Pikesville	Maryland	United States	21208
22	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
23	Boston Clinical Trials	Brighton	Massachusetts	United States	02135
24	Mercy Health Research	Saint Louis	Missouri	United States	63141
25	Premier Psychiatry Group, LLC	Lincoln	Nebraska	United States	68510
26	CRI Worldwide, LLC - Lourdes Division	Willingboro	New Jersey	United States	08046
27	Social Psychiatric Research Institute	Brooklyn	New York	United States	11235
28	Eastside Comprehensive Medical Service	New York	New York	United States	10021
29	Neurobehavioral Clinical Research	Canton	Ohio	United States	44718
30	University of Cincinnati Medical Center	Cincinnati	Ohio	United States	45219
31	Neurology & Neuroscience Center of Ohio	Toledo	Ohio	United States	43623
32	SP Research	Oklahoma City	Oklahoma	United States	73112
33	Willamette Valley Clinical Studies	Eugene	Oregon	United States	97404
34	Summit Research Network	Portland	Oregon	United States	97210
35	CRI Worldwide, LLC - Kirkbride Division	Philadelphia	Pennsylvania	United States	19139
36	Medical University of South Carolina	North Charleston	South Carolina	United States	29406
37	CNS Healthcare	Memphis	Tennessee	United States	38119
38	Research Strategies	Memphis	Tennessee	United States	38119
39	FutureSearch Trials	Austin	Texas	United States	78731
40	Claghorn-Lesem Research Clinic, Inc.	Houston	Texas	United States	77008
41	University of Utah, Department of Psychiatry	Salt Lake City	Utah	United States	84132
42	Northwest Clinical Research Center	Bellevue	Washington	United States	98007
43	Summit Research	Seattle	Washington	United States	98104
44	Caribbean Research and Education Center	Bayamon		Puerto Rico	00959
45	Dharma Institute and Research Center	San Juan		Puerto Rico	00907