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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
agomelatine
placebo
Sponsored by
Novartis
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:

  • Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria
  • HAM-D17 total score > or = 22 at Screening and Baseline
  • CGI-Severity score > or = 4 at Screening and Baseline
  • Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase

Exclusion Criteria:

  • History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
  • Any current Axis I disorder other than major depressive disorder 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
  • Female patients of childbearing potential who are not using effective contraception

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17)

Secondary Outcome Measures

To evaluate the 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
To evaluate the proportion of patients who achieve remission at Week 8, where remission is defined by a total score of < or =7 on the HAM-D17
To evaluate efficacy with respect to the proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the baseline HAM-D17 at week 8
To evaluate the change from baseline to week 8 on the subscale scores (Maier, anxiety, retardation and sleep) of the clinician-rated HAM-D17
To evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8

Full Information

First Posted
December 11, 2006
Last Updated
December 15, 2020
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00411099
Brief Title
Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
Official Title
An 8-week, Randomized, Double-blind, Fixed Dosage, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy, Safety and Tolerability of Agomelatine 25 mg and 50 mg in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week, Open-label Extension (CAGO178A2301E)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label 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
508 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
agomelatine
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
To evaluate the change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
To evaluate the 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
To evaluate the proportion of patients who achieve remission at Week 8, where remission is defined by a total score of < or =7 on the HAM-D17
Time Frame
8 weeks
Title
To evaluate efficacy with respect to the proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the baseline HAM-D17 at week 8
Time Frame
8 weeks
Title
To evaluate the change from baseline to week 8 on the subscale scores (Maier, anxiety, retardation and sleep) of the clinician-rated HAM-D17
Time Frame
8 weeks
Title
To evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8
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: Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria HAM-D17 total score > or = 22 at Screening and Baseline CGI-Severity score > or = 4 at Screening and Baseline Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase Exclusion Criteria: History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder Any current Axis I disorder other than major depressive disorder 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 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
Novartis Investigative Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Novartis Investigative Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Novartis Investigative Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Novartis Investigative Site
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
Novartis Investigative Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Novartis Investigative Site
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Novartis Investigative Site
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Facility Name
Novartis Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92126
Country
United States
Facility Name
Novartis Investigative Site
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Novartis Investigative Site
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Novartis Investigative Site
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Novartis Investigative Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Novartis Investigative Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Novartis Investigative Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Novartis Investigative Site
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Novartis Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Novartis Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Novartis Investigative Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Novartis Investigative Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Novartis Investigative Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Novartis Investigative Site
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21801
Country
United States
Facility Name
Novartis Investigative Site
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Novartis Investigative Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
Novartis Investigative Site
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Novartis Investigative Site
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Novartis Investigative Site
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Novartis Investigative Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Novartis Investigative Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Novartis Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Novartis Investigative Site
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Novartis Investigative Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Novartis Investigative Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Novartis Investigative Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Novartis Investigative Site
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Novartis Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Novartis Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
Facility Name
Novartis Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Novartis Investigative Site
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Novartis Investigative Site
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23112
Country
United States
Facility Name
Novartis Investigative Site
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
Facility Name
Novartis Investigative Site
City
Bayamon
ZIP/Postal Code
00959
Country
Puerto Rico
Facility Name
Novartis Investigative Site
City
Rio Piedras
Country
Puerto Rico

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2625
Description
Results for CAGO178A2301 from the Novartis Clinical Trials website

Learn more about this trial

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

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