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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01110889
Collaborator
(none)
582
Enrollment
48
Locations
3
Arms
12.1
Patients Per Site

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
  • Drug: Agomelatine (AGO178C)
  • Drug: Agomelatine (AGO178C)
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
582 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Jul 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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]

  2. 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]

  3. 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]

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

  5. 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:
No
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 Birmingham Psychiatry Birmingham Alabama United States 25226
2 Southwestern Research Institute Beverly Hills California United States 90210
3 Pharmacology Research Institute Encino California United States 91316
4 Mood & Anxiety Research Fresno California United States 93720
5 Excell Research, Inc Oceanside California United States 92056
6 Cnri-La, Llc Pico Rivera California United States 90660
7 CNRI San Diego San Diego California United States 92102
8 University of California San Diego Medical Center San Diego California United States 92103
9 University of Colorado Denver Aurora Colorado United States 80045
10 Western Affiliated Research Institute Denver Colorado United States 80204
11 Clinical Research Institute of South Florida Hialeah Florida United States 33013
12 Florida Clinical Research Center LLC Maitland Florida United States 32751
13 CNS Healthcare Orlando Florida United States 32806
14 Broward Research Group Pembroke Pines Florida United States 33026
15 Quantum Lab. N. Broward Memory Disorder Center Pompano Beach Florida United States 33064
16 Atlanta Center for Medical Research Atlanta Georgia United States 30308
17 Northwest Behavioral Research Center Marietta Georgia United States 30060
18 Hawaii Clinical Research Center Honolulu Hawaii United States 96813
19 Mountain West Clinical Trials Eagle Idaho United States 83616
20 Rush University Medical Center Chicago Illinois United States 60612
21 Psychiatric Associates Overland Park Kansas United States 66211
22 CTT Clinical Trials Technology Prairie Village Kansas United States 66206
23 Clinical Trials Management Metairie Louisiana United States 70006
24 Mount Auburn Medical Associates Watertown Massachusetts United States 02472
25 Coastal Research Associates Weymouth Massachusetts United States 02190
26 Comprehensive Psychiatric Associates Gladstone Missouri United States 64114
27 Psychopharmacology Research Association of Princeton Princeton New Jersey United States 08540
28 Bio Behavioral Health Toms River New Jersey United States 08755
29 Albuquerque Neuroscience Albuquerque New Mexico United States 87109
30 Neurological Associates Of Albany, P.C. Albany New York United States 12208
31 Montefiore Medical Center Bronx New York United States 10467
32 Neurobehavioral Research Inc. Cedarhurst New York United States 11516
33 Finger Lakes Clinical Research Rochester New York United States 14618
34 Odyssey Research Services Fargo North Dakota United States 58104
35 The Ohio State University - Harding Hospital Columbus Ohio United States 43210
36 Midwest Clinical Research Center Dayton Ohio United States 45417
37 IPS Research Company Oklahoma City Oklahoma United States 73103
38 Cutting Edge Research Oklahoma City Oklahoma United States 73116
39 Sunstone Medical Research, LLC Medford Oregon United States 97504
40 Lehigh Center for Clinical Research Allentown Pennsylvania United States 18104
41 Psychiatric Consultants Franklin Tennessee United States 37067
42 KRK Medical Research Dallas Texas United States 75230
43 FutureSearch Trials of Dallas Dallas Texas United States 75231
44 InSite Clinical Research DeSoto Texas United States 75115
45 Texas Center for Drug Development Houston Texas United States 77081
46 Alliance Research Group, LLC Richmond Virginia United States 23230
47 Northwest Clinical Research Center Bellevue Washington United States 98007
48 Inspira Clinical Research San Juan Puerto Rico 00918

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01110889
Other Study ID Numbers:
  • CAGO178C2301
First Posted:
Apr 27, 2010
Last Update Posted:
Dec 23, 2020
Last Verified:
Feb 1, 2013
Keywords provided by Novartis Pharmaceuticals
Agomelatine
Major Depressive Disorder
MDD
depression
Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
S 20098

Study Results

No Results Posted as of Dec 23, 2020