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

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)

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Agomelatine (AGO178C)

• Study Type: Interventional
• Enrollment (Actual): 582
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6663
• Click here for more information about this study:

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: April 23, 2010
• First Submitted That Met QC Criteria: April 26, 2010
• First Posted (Estimate): April 27, 2010

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: depression; MDD; Major Depressive Disorder; Agomelatine
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives; S 20098
• Other Study ID Numbers: CAGO178C2301