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

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00411099
Collaborator
(none)
508
Enrollment
44
Locations
3
Arms
11.5
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 :
508 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 (CAGO178A2301E)
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. 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) [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 Scottsdale Arizona United States 85251
2 Novartis Investigative Site Little Rock Arkansas United States 72205
3 Novartis Investigative Site Cerritos California United States 90703
4 Novartis Investigative Site El Centro California United States 92243
5 Novartis Investigative Site Garden Grove California United States 92845
6 Novartis Investigative Site Irvine California United States 92618
7 Novartis Investigative Site Lafayette California United States 94549
8 Novartis Investigative Site San Diego California United States 92126
9 Novartis Investigative Site Temecula California United States 92591
10 Novartis Investigative Site Cromwell Connecticut United States 06416
11 Novartis Investigative Site Hamden Connecticut United States 06518
12 Novartis Investigative Site Bradenton Florida United States 34208
13 Novartis Investigative Site Jacksonville Florida United States 32216
14 Novartis Investigative Site Maitland Florida United States 32751
15 Novartis Investigative Site Port Charlotte Florida United States 33952
16 Novartis Investigative Site Atlanta Georgia United States 30308
17 Novartis Investigative Site Atlanta Georgia United States 30329
18 Novartis Investigative Site Marietta Georgia United States 30060
19 Novartis Investigative Site Overland Park Kansas United States 66212
20 Novartis Investigative Site Rockville Maryland United States 20852
21 Novartis Investigative Site Salisbury Maryland United States 21801
22 Novartis Investigative Site Pittsfield Massachusetts United States 01201
23 Novartis Investigative Site Farmington Hills Michigan United States 48336
24 Novartis Investigative Site Rochester Hills Michigan United States 48307
25 Novartis Investigative Site Saint Peters Missouri United States 63376
26 Novartis Investigative Site Princeton New Jersey United States 08540
27 Novartis Investigative Site Albuquerque New Mexico United States 87102
28 Novartis Investigative Site Brooklyn New York United States 11235
29 Novartis Investigative Site New York New York United States 10021
30 Novartis Investigative Site Beachwood Ohio United States 44122
31 Novartis Investigative Site Dayton Ohio United States 45408
32 Novartis Investigative Site Tulsa Oklahoma United States 74136
33 Novartis Investigative Site Eugene Oregon United States 97404
34 Novartis Investigative Site North Charleston South Carolina United States 29406
35 Novartis Investigative Site Nashville Tennessee United States 37203
36 Novartis Investigative Site Austin Texas United States 78754
37 Novartis Investigative Site Dallas Texas United States 75231
38 Novartis Investigative Site Houston Texas United States 77007
39 Novartis Investigative Site Salt Lake City Utah United States 84107
40 Novartis Investigative Site Bennington Vermont United States 05201
41 Novartis Investigative Site Midlothian Virginia United States 23112
42 Novartis Investigative Site Bothell Washington United States 98011
43 Novartis Investigative Site Bayamon Puerto Rico 00959
44 Novartis Investigative Site Rio Piedras Puerto Rico

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:
NCT00411099
Other Study ID Numbers:
  • CAGO178A2301
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