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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01110889
First received: April 23, 2010
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Major Depressive Disorder
Drug: Agomelatine (AGO178C)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients who achieve remission [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability by adverse events and serious adverse events, and assessment of suicidal ideation and behavior by Columbia Suicide Severity Rating Scale. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 582
Study Start Date: May 2010
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AGO178C 0.5 mg /day Drug: Agomelatine (AGO178C)
Experimental: AGO178C 1 mg / day Drug: Agomelatine (AGO178C)
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110889

  Hide Study Locations
Locations
United States, Alabama
Birmingham Psychiatry
Birmingham, Alabama, United States, 25226
United States, California
Southwestern Research Institute
Beverly Hills, California, United States, 90210
Pharmacology Research Institute
Encino, California, United States, 91316
Mood & Anxiety Research
Fresno, California, United States, 93720
Excell Research, Inc
Oceanside, California, United States, 92056
Cnri-La, Llc
Pico Rivera, California, United States, 90660
University of California San Diego Medical Center
San Diego, California, United States, 92103
CNRI San Diego
San Diego, California, United States, 92102
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Western Affiliated Research Institute
Denver, Colorado, United States, 80204
United States, Florida
Clinical Research Institute of South Florida
Hialeah, Florida, United States, 33013
Florida Clinical Research Center LLC
Maitland, Florida, United States, 32751
CNS Healthcare
Orlando, Florida, United States, 32806
Broward Research Group
Pembroke Pines, Florida, United States, 33026
Quantum Lab. N. Broward Memory Disorder Center
Pompano Beach, Florida, United States, 33064
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
Northwest Behavioral Research Center
Marietta, Georgia, United States, 30060
United States, Hawaii
Hawaii Clinical Research Center
Honolulu, Hawaii, United States, 96813
United States, Idaho
Mountain West Clinical Trials
Eagle, Idaho, United States, 83616
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Kansas
Psychiatric Associates
Overland Park, Kansas, United States, 66211
CTT Clinical Trials Technology
Prairie Village, Kansas, United States, 66206
United States, Louisiana
Clinical Trials Management
Metairie, Louisiana, United States, 70006
United States, Massachusetts
Mount Auburn Medical Associates
Watertown, Massachusetts, United States, 02472
Coastal Research Associates
Weymouth, Massachusetts, United States, 02190
United States, Missouri
Comprehensive Psychiatric Associates
Gladstone, Missouri, United States, 64114
United States, New Jersey
Psychopharmacology Research Association of Princeton
Princeton, New Jersey, United States, 08540
Bio Behavioral Health
Toms River, New Jersey, United States, 08755
United States, New Mexico
Albuquerque Neuroscience
Albuquerque, New Mexico, United States, 87109
United States, New York
Neurological Associates Of Albany, P.C.
Albany, New York, United States, 12208
Montefiore Medical Center
Bronx, New York, United States, 10467
Neurobehavioral Research Inc.
Cedarhurst, New York, United States, 11516
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
United States, North Dakota
Odyssey Research Services
Fargo, North Dakota, United States, 58104
United States, Ohio
The Ohio State University - Harding Hospital
Columbus, Ohio, United States, 43210
Midwest Clinical Research Center
Dayton, Ohio, United States, 45417
United States, Oklahoma
Cutting Edge Research
Oklahoma City, Oklahoma, United States, 73116
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Sunstone Medical Research, LLC
Medford, Oregon, United States, 97504
United States, Pennsylvania
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States, 18104
United States, Tennessee
Psychiatric Consultants
Franklin, Tennessee, United States, 37067
United States, Texas
FutureSearch Trials of Dallas
Dallas, Texas, United States, 75231
KRK Medical Research
Dallas, Texas, United States, 75230
InSite Clinical Research
Desoto, Texas, United States, 75115
Texas Center for Drug Development
Houston, Texas, United States, 77081
United States, Virginia
Alliance Research Group, LLC
Richmond, Virginia, United States, 23230
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Puerto Rico
Inspira Clinical Research
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01110889     History of Changes
Other Study ID Numbers: CAGO178C2301
Study First Received: April 23, 2010
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Agomelatine
Major Depressive Disorder
MDD
depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
S 20098
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014