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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Agomelatine (AGO178C)
Agomelatine (AGO178C)
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Agomelatine, Major Depressive Disorder, MDD, depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Birmingham Psychiatry
  • Southwestern Research Institute
  • Pharmacology Research Institute
  • Mood & Anxiety Research
  • Excell Research, Inc
  • Cnri-La, Llc
  • CNRI San Diego
  • University of California San Diego Medical Center
  • University of Colorado Denver
  • Western Affiliated Research Institute
  • Clinical Research Institute of South Florida
  • Florida Clinical Research Center LLC
  • CNS Healthcare
  • Broward Research Group
  • Quantum Lab. N. Broward Memory Disorder Center
  • Atlanta Center for Medical Research
  • Northwest Behavioral Research Center
  • Hawaii Clinical Research Center
  • Mountain West Clinical Trials
  • Rush University Medical Center
  • Psychiatric Associates
  • CTT Clinical Trials Technology
  • Clinical Trials Management
  • Mount Auburn Medical Associates
  • Coastal Research Associates
  • Comprehensive Psychiatric Associates
  • Psychopharmacology Research Association of Princeton
  • Bio Behavioral Health
  • Albuquerque Neuroscience
  • Neurological Associates Of Albany, P.C.
  • Montefiore Medical Center
  • Neurobehavioral Research Inc.
  • Finger Lakes Clinical Research
  • Odyssey Research Services
  • The Ohio State University - Harding Hospital
  • Midwest Clinical Research Center
  • IPS Research Company
  • Cutting Edge Research
  • Sunstone Medical Research, LLC
  • Lehigh Center for Clinical Research
  • Psychiatric Consultants
  • KRK Medical Research
  • FutureSearch Trials of Dallas
  • InSite Clinical Research
  • Texas Center for Drug Development
  • Alliance Research Group, LLC
  • Northwest Clinical Research Center
  • Inspira Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

AGO178C 0.5 mg /day

AGO178C 1 mg / day

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

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
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
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
Proportion of patients who achieve remission
Safety and tolerability by adverse events and serious adverse events, and assessment of suicidal ideation and behavior by Columbia Suicide Severity Rating Scale.

Full Information

First Posted
April 23, 2010
Last Updated
December 15, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01110889
Brief Title
Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder
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 Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Agomelatine, Major Depressive Disorder, MDD, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
582 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AGO178C 0.5 mg /day
Arm Type
Experimental
Arm Title
AGO178C 1 mg / day
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Agomelatine (AGO178C)
Intervention Type
Drug
Intervention Name(s)
Agomelatine (AGO178C)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Proportion of patients who achieve remission
Time Frame
8 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Psychiatry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
25226
Country
United States
Facility Name
Southwestern Research Institute
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Mood & Anxiety Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Excell Research, Inc
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Cnri-La, Llc
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
CNRI San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Western Affiliated Research Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Clinical Research Institute of South Florida
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Florida Clinical Research Center LLC
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
CNS Healthcare
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Broward Research Group
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Quantum Lab. N. Broward Memory Disorder Center
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northwest Behavioral Research Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Hawaii Clinical Research Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Mountain West Clinical Trials
City
Eagle
State/Province
Idaho
ZIP/Postal Code
83616
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Psychiatric Associates
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
CTT Clinical Trials Technology
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Clinical Trials Management
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Mount Auburn Medical Associates
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Coastal Research Associates
City
Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
Facility Name
Comprehensive Psychiatric Associates
City
Gladstone
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Psychopharmacology Research Association of Princeton
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Bio Behavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Albuquerque Neuroscience
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Neurological Associates Of Albany, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Neurobehavioral Research Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Odyssey Research Services
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
The Ohio State University - Harding Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Cutting Edge Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Sunstone Medical Research, LLC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Lehigh Center for Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Psychiatric Consultants
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
KRK Medical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
FutureSearch Trials of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Texas Center for Drug Development
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Alliance Research Group, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Inspira Clinical Research
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6563
Description
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6663
URL
http://depressiondrugstudy.com
Description
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Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder

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