Clincosm LogoSign in Get a demo

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

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00411242
Collaborator
(none)
503
Enrollment
51
Locations
3
Arms
9.9
Patients Per Site

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
503 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, 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 (CAGO178A2302E)
Study Start Date :
Dec 1, 2006
Actual Primary Completion Date :
Jan 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: agomelatine
Experimental: 2

Drug: agomelatine
Placebo Comparator: 3

Drug: placebo

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17) [8 weeks]

Secondary Outcome Measures

  1. 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 [8 weeks]

  2. 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 [8 weeks]

  3. 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 [8 weeks]

  4. To evaluate the change from baseline to week 8 on the subscale scores (Maier, anxiety, retardation and sleep) of the clinician-rated HAM-D17 [8 weeks]

  5. To evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8 [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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Mesa Arizona United States 85210
2 Novartis Investigative Site Los Angeles California United States 90024
3 Novartis Investigative Site Oceanside California United States 92056
4 Novartis Investigative Site San Diego California United States 92103
5 Novartis Investigative Site San Diego California United States 92108
6 Novartis Investigative Site San Diego California United States 92123
7 Novartis Investigative Site Denver Colorado United States 80212
8 Novartis Investigative Site Daytona Beach Florida United States 32124
9 Novartis Investigative Site Fort Lauderdale Florida United States 33319
10 Novartis Investigative Site Miami Florida United States 33143
11 Novartis Investigative Site North Miami Florida United States 33161
12 Novartis Investigative Site North Miami Florida United States
13 Novartis Investigative Site Orlando Florida United States 32806
14 Novartis Investigative Site Atlanta Georgia United States 30328
15 Novartis Investigative Site Smyrna Georgia United States 30080
16 Novartis Investigative Site Hoffman Estates Illinois United States 60169
17 Novartis Investigative Site Hoffman Estates Illinois United States 60194
18 Novartis Investigative Site Park Ridge Illinois United States 60068
19 Novartis Investigative Site Skokie Illinois United States 60076
20 Novartis Investigative Site Prairie Village Kansas United States 66206
21 Novartis Investigative Site Topeka Kansas United States 66606
22 Novartis Investigative Site Wichita Kansas United States 67207
23 Novartis Investigative Site Shreveport Louisiana United States 71103
24 Novartis Investigative Site Glen Burnie Maryland United States 21061
25 Novartis Investigative Site Las Vegas Nevada United States 89128
26 Novartis Investigative Site Kenilworth New Jersey United States 07033
27 Novartis Investigative Site Summit New Jersey United States 07901
28 Novartis Investigative Site Toms River New Jersey United States 08755
29 Novartis Investigative Site Brooklyn New York United States 11201
30 Novartis Investigative Site Cedarhurst New York United States 11516
31 Novartis Investigative Site Fresh Meadows New York United States 11366
32 Novartis Investigative Site New York New York United States 10021
33 Novartis Investigative Site New York New York United States 10023
34 Novartis Investigative Site Staten Island New York United States 10312
35 Novartis Investigative Site West Allis New York United States 53227
36 Novartis Investigative Site Raleigh North Carolina United States 27609
37 Novartis Investigative Site Cleveland Ohio United States 44122
38 Novartis Investigative Site Toledo Ohio United States 43623
39 Novartis Investigative Site Oklahoma City Oklahoma United States 73103
40 Novartis Investigative Site Medford Oregon United States 97504
41 Novartis Investigative Site Portland Oregon United States 97210
42 Novartis Investigative Site Philadelphia Pennsylvania United States 19104
43 Novartis Investigative Site Memphis Tennessee United States 38119
44 Novartis Investigative Site Austin Texas United States 78756
45 Novartis Investigative Site Houston Texas United States 77008
46 Novartis Investigative Site Houston Texas United States 77090
47 Novartis Investigative Site Irving Texas United States 75062
48 Novartis Investigative Site Arlington Virginia United States 22201
49 Novartis Investigative Site Bellevue Washington United States 98004
50 Novartis Investigative Site Seattle Washington United States 98104
51 Novartis Investigative Site Milwaukee Wisconsin United States 53227

Sponsors and Collaborators

  • Novartis

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT00411242
Other Study ID Numbers:
  • CAGO178A2302
First Posted:
Dec 13, 2006
Last Update Posted:
Dec 23, 2020
Last Verified:
May 1, 2012
Keywords provided by Novartis
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