Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT01156415

Collaborator

(none)

837

Enrollment

Locations

Arms

Duration (Months)

8.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder over a 52-week open-label phase.

Cohort I is restricted to include patients who have completed a previous Novartis agomelatine (178C) Double-blind study.

Cohort II will include de-novo patients (those who did not participate in a previous agomelatine 178C study) and will only be open for a limited time span ranging from approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: AGO178 Drug: AGO178	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

837 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD)

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Agomelatine (AGO178) 0.5 mg	Drug: AGO178
Experimental: Agomelatine (AGO178) 1 mg	Drug: AGO178

Arm

Intervention/Treatment

Experimental: Agomelatine (AGO178) 0.5 mg

Drug: AGO178

Experimental: Agomelatine (AGO178) 1 mg

Drug: AGO178

Outcome Measures

Primary Outcome Measures

Reports of adverse events, serious adverse events, changes in laboratory values, ECGs, vital signs, physical examination, and Columbia Suicidality Severity Rating Scale [52 weeks]

Secondary Outcome Measures

Change from Baseline to Week 6, 8, 12, 28, 36 and 52 on total score of the Hamilton Depression Rating Scale [Week 6, 8, 12, 28, 36 and 52]
Proportion of patients who demonstrate clinical improvement at Week 6,8,12, 28,36 and 52, where improvement is defined by a score of 1 or 2 on the CGI-I scale [Week 6, 8, 12, 28, 36 and 52]
Overall illness severity as measured by change from Baseline on CGI-S (Clinical Global Impression of severity scale) at week 52 [Week 52]
Patients' ability to function in daily life as measured by change from Baseline on total score of Sheehan Disability Scale at week 52 [Week 52]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 71 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Key Inclusion Criteria Cohort I:

Documentation of completion of a Novartis AGO178C Double-blind Study in MDD patients.
Male and female adults, 18 through 71 years of age, inclusive (i.e., same age range as for Double-blind Study, but with upper age limit increased by 1-year to accommodate patients whose age increased during the Double-blind Study).
Female patients should continue to use effective contraception as defined in double-blind study protocol.

Inclusion Criteria:

Key Inclusion criteria Cohort II:

Male and female adults, 18 through 70 years of age, inclusive.
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:

Key Exclusion Criteria Cohort I:

Concomitant use of fluvoxamine.
Any significant medical condition that emerged during Double-blind Phase of a previous study, which may interfere with study participation and/or study assessments as assessed by the investigator.

Exclusion Criteria:

Key Exclusion criteria Cohort II:

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.
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	Birmingham	Alabama	United States	35294
2	Advanced Research Associates	Glendale	Arizona	United States	85308
3	Southwest Health Ltd dba The Mollen Clinic	Scottsdale	Arizona	United States	85254
4	Clinical Study Centers, LLC	Little Rock	Arkansas	United States	72205
5	Southwestern Research Institute	Beverly Hills	California	United States	90210
6	Comprehensive Neuroscience	Cerritos	California	United States	90703
7	ATP Clinical Research, Inc	Costa Mesa	California	United States	92626
8	Collaborative Neuroscience Network	Garden Grove	California	United States	92845
9	Pharmacology Research Institute	Newport Beach	California	United States	92660
10	Pacific Clinical Research Medical Group	Orange	California	United States	92868
11	CNRI-San Diego, LLC	San Diego	California	United States	92102
12	University of California, San Diego Medical Center	San Diego	California	United States	92103
13	Neuropsychiatric Research Center of Orange County	Santa Ana	California	United States	92701
14	Viking Clinical Research Center	Temecula	California	United States	92591
15	Collaborative Neuroscience	Torrance	California	United States	90502
16	University of Colorado	Aurora	Colorado	United States	80045
17	Western Affiliated Research Institute	Denver	Colorado	United States	80209
18	Middlesex Hospital	Middletown	Connecticut	United States	06457
19	Clinical Studies	Altamonte Springs	Florida	United States	32701
20	Florida Clinical Research Center, LLC	Bradenton	Florida	United States	34208
21	Arocha Research Center	Coral Gables	Florida	United States	33134
22	CNS Clinical Research	Coral Springs	Florida	United States	33067
23	Sjs Clinical Research	Destin	Florida	United States	32541
24	MD Clinical	Hallandale Beach	Florida	United States	33009
25	CNS Healthcare	Jacksonville	Florida	United States	32216
26	Florida Clinical Research Center	Maitland	Florida	United States	34201
27	CNS Healthcare	Orlando	Florida	United States	32806
28	Quantum Lab. at N. Broward Memory Disorder Center	Pompano Beach	Florida	United States	33064
29	Comprehensive NeuroScience, Inc.	Saint Petersburg	Florida	United States	33716
30	Miami Research Associates	South Miami	Florida	United States	33143
31	Janus Center for Psychiatric Research	West Palm Beach	Florida	United States	33407
32	Emory University	Atlanta	Georgia	United States	30306
33	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30308
34	Northwest Behavioral Research Center	Marietta	Georgia	United States	30060
35	Hawaii Clinical Research Center	Honolulu	Hawaii	United States	96813
36	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois	United States	60169
37	Joliet Center for Clinical Research	Joliet	Illinois	United States	60435
38	Capstone Clinical Research	Libertyville	Illinois	United States	60048
39	Rush University Medical Center	Skokie	Illinois	United States	60076
40	Deaconess Clinic Gateway	Newburgh	Indiana	United States	47630
41	Pharmasite Research	Pikesville	Maryland	United States	21208
42	Boston Clinical Trials	Boston	Massachusetts	United States	02135
43	Mount Auburn Medical Associates	Watertown	Massachusetts	United States	02472
44	Coastal Research Associates	Weymouth	Massachusetts	United States	02190
45	Michigan State University	East Lansing	Michigan	United States	48824
46	Pine Rest Christian Mental Health Services	Grand Rapids	Michigan	United States	49548
47	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan	United States	48307
48	Comprehensive Psychiatric Associates	Gladstone	Missouri	United States	64118
49	Robert Wood Johnson Medical School	Piscataway	New Jersey	United States	08854
50	Bio Behavioral Health	Toms River	New Jersey	United States	08755
51	CRI Worldwide	Willingboro	New Jersey	United States	08046
52	Albuquerque Neuroscience	Albuquerque	New Mexico	United States	87109
53	Neurological Associates Of Albany	Albany	New York	United States	12208
54	Montefiore Medical Center	Bronx	New York	United States	10467
55	Social Psychiatry Research, Inc./ SPRI	Brooklyn	New York	United States	11235
56	Neurobehavioral Research, Inc.	Cedarhurst	New York	United States	11516
57	Eastside Comprehensive Medical Service	New York	New York	United States	10021
58	Medical & Behavior Health Research	New York	New York	United States	10023
59	The Medical Research Network, LLC	New York	New York	United States	10128
60	Richmond Behavioral Associates	Staten Island	New York	United States	10312
61	Pharmquest	Greensboro	North Carolina	United States	27408
62	Zarzar Psychiatric Associates	Raleigh	North Carolina	United States	27607
63	Piedmont Medical Research Associates, Inc.	Winston-Salem	North Carolina	United States	27103
64	Odyssey Research Services	Fargo	North Dakota	United States	58104
65	Neuro Behavioral Clinical Research	Canton	Ohio	United States	44718
66	University of Cincinnati Medical Center	Cincinnati	Ohio	United States	45219
67	North Star Medical Research	Cleveland	Ohio	United States	44130
68	The Ohio State Universtiy - Harding Hospital	Columbus	Ohio	United States	43210
69	Neurology & Neuroscience Center of Ohio	Toledo	Ohio	United States	43623
70	IPS Research	Oklahoma City	Oklahoma	United States	73103
71	SP Research	Oklahoma City	Oklahoma	United States	73112
72	Cutting Edge Research	Oklahoma City	Oklahoma	United States	73116
73	Sunstone Medical Research, LLC	Medford	Oregon	United States	97504
74	Oregon Center for Clinical Investigations	Portland	Oregon	United States	97210
75	Summit Research	Portland	Oregon	United States	97210
76	Lehigh Center for Clinical Research	Allentown	Pennsylvania	United States	18104
77	Suburban Research Associates	Media	Pennsylvania	United States	19063
78	CRI Worldwide, LLC	Philadelphia	Pennsylvania	United States	19139
79	Medical University of South Carolina	Charleston	South Carolina	United States	29406
80	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee	United States	38119
81	Research Strategies of Memphis	Memphis	Tennessee	United States	38119
82	Clinical Research Associates	Nashville	Tennessee	United States	37203
83	Millwood Hospital	Arlington	Texas	United States	76011
84	FutureSearch Trials of Dallas	Dallas	Texas	United States	75231
85	InSite Clinical Research	DeSoto	Texas	United States	75115
86	Bayou City Research Limited	Houston	Texas	United States	77007
87	Claghorn Lesem Research Clinic, Inc.	Houston	Texas	United States	77008
88	Texas Center for Drug Development	Houston	Texas	United States	77081
89	Grayline Clinical Drug Trials	Wichita Falls	Texas	United States	76309
90	Radiant Research	Salt Lake City	Utah	United States	84107
91	University of Utah Mood Disorders Clinic	Salt Lake City	Utah	United States	84132
92	Alliance Research Group, LLC	Richmond	Virginia	United States	23230
93	Northwest Clinical Research Center	Bellevue	Washington	United States	98007
94	Frontier Institute	Spokane	Washington	United States	99204
95	Independent Psychiatric Consultants	Waukesha	Wisconsin	United States	53188
96	Centro de Investigacion Clinica Psiquiatrica	Ponce		Puerto Rico	00731
97	Dharma Institute and Research Center	San Juan		Puerto Rico	00907
98	INSPIRA Clinical Research	San Juan		Puerto Rico	00918