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

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00467402
Collaborator
(none)
644
Enrollment
78
Locations
3
Arms
8.3
Patients Per Site

Study Details

Study Description

Brief Summary

This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment. Patients demonstrating stable response at the end of the open-label treatment phase will be assigned to receive agomelatine or placebo for 52 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
644 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A 52-week, Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study of the Long-term Efficacy, Tolerability and Safety of Agomelatine 25 and 50 mg in the Prevention of Relapse of Major Depressive Disorder (MDD) Following Open-label Treatment of 16-24 Weeks
Study Start Date :
Apr 1, 2007
Actual Primary Completion Date :
Sep 1, 2009

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. Time to relapse, where relapse is defined by the occurrence of any one of the following: [Primary efficacy variable is measured from randomization to relapse]

  2. Hamilton Depression Rating Scale total score ≥16 at two consecutive visits; [Primary efficacy variable is measured from randomization to relapse]

  3. hospitalization due to depression; [Primary efficacy variable is measured from randomization to relapse]

  4. suicide attempt or suicide; [Primary efficacy variable is measured from randomization to relapse]

  5. discontinuation due to lack of efficacy according to Investigator judgment. [Primary efficacy variable is measured from randomization to relapse]

Secondary Outcome Measures

  1. Proportion of patients who demonstrate clinical improvement at the end of the double-blind continuation phase, where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale. [Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase]

  2. Proportion of patients experiencing relapse during the double-blind continuation phase. [Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase]

  3. Proportion of patients who achieve remission at the end of the double-blind continuation phase, where remission is defined by a total score of ≤7 on the HAM-D. [Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase]

  4. Change from randomization to the end of the double-blind continuation phase, on the Hospital Anxiety and Depression (HAD) total score and subscale scores. [Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male and female adults, 18 through 70 years of age, inclusive

  • Diagnosis of Major Depressive Disorder, recurrent episode, according to Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria

  • A history of at least two previous episodes of Major Depression plus the current episode

  • Hamilton Depression Rating Scale (HAM-D17) total score ≥ 22 at Screening and Baseline

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

  • Use of any psychoactive medication after the screening visit

  • Patients who have been previously treated with agomelatine

  • 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 Birmingham Alabama United States 35226
2 Novartis Investigative Site Peoria Arizona United States 85381
3 Novartis Investigative Site Tucson Arizona United States 85724
4 Novartis Investigative Site Beverly Hills California United States 90210
5 Novartis Investigative Site Costa Mesa California United States 92626
6 Novartis Investigative Site Encino California United States 91316
7 Novartis Investigative Site Glendale California United States 91206
8 Novartis Investigative Site Los Angeles California United States 90024
9 Novartis Investigative Site Newport Beach California United States 92660
10 Novartis Investigative Site Oceanside California United States 92056
11 Novartis Investigative Site Sacramento California United States 95817
12 Novartis Investigative Site Sherman Oaks California United States 91403
13 Novartis Investigative Site Temecula California United States 92591
14 Novartis Investigative Site Wheat Ridge Colorado United States 80033
15 Novartis Investigative Site Bradenton Florida United States 34208
16 Novartis Investigative Site Coral Springs Florida United States 33065
17 Novartis Investigative Site Fort Myers Florida United States 33912
18 Novartis Investigative Site Gainesville Florida United States 32607
19 Novartis Investigative Site Jacksonville Florida United States 32216
20 Novartis Investigative Site Saint Petersburg Florida United States 33702
21 Novartis Investigative Site Venice Florida United States 34285
22 Novartis Investigative Site West Palm Beach Florida United States 33407
23 Novartis Investigative Site Atlanta Georgia United States 30328
24 Novartis Investigative Site Chicago Illinois United States 60611
25 Novartis Investigative Site Chicago Illinois United States 60640
26 Novartis Investigative Site Libertyville Illinois United States 60048
27 Novartis Investigative Site Overland Park Kansas United States 66211
28 Novartis Investigative Site Topeka Kansas United States 66606
29 Novartis Investigative Site New Orleans Louisiana United States 70114
30 Novartis Investigative Site Rockville Maryland United States 20852
31 Novartis Investigative Site Towson Maryland United States 21204
32 Novartis Investigative Site Towson Maryland United States 85724
33 Novartis Investigative Site Boston Massachusetts United States 02135
34 Novartis Investigative Site Braintree Massachusetts United States 02184
35 Novartis Investigative Site Worcester Massachusetts United States 01605
36 Novartis Investigative Site Farmington Hills Michigan United States 48336
37 Novartis Investigative Site Minneapolis Minnesota United States 55454
38 Novartis Investigative Site Kansas City Missouri United States 64111
39 Novartis Investigative Site Kansas City Missouri United States 66160
40 Novartis Investigative Site Saint Louis Missouri United States 63033
41 Novartis Investigative Site Saint Louis Missouri United States 63044
42 Novartis Investigative Site Saint Louis Missouri United States 63118
43 Novartis Investigative Site Omaha Nebraska United States 68198
44 Novartis Investigative Site Newark New Jersey United States 07103
45 Novartis Investigative Site Albuquerque New Mexico United States 87102
46 Novartis Investigative Site Bronx New York United States 10467
47 Novartis Investigative Site Buffalo New York United States 14215
48 Novartis Investigative Site New York New York United States 10021
49 Novartis Investigative Site New York New York United States 10029
50 Novartis Investigative Site Chapel Hill North Carolina United States 27599
51 Novartis Investigative Site Raleigh North Carolina United States 27609
52 Novartis Investigative Site Cleveland Ohio United States 44195
53 Novartis Investigative Site Columbus Ohio United States 43210
54 Novartis Investigative Site Toledo Ohio United States 43623
55 Novartis Investigative Site Portland Oregon United States 97210
56 Novartis Investigative Site Portland Oregon United States 97239
57 Novartis Investigative Site Rhododendron Oregon United States 97049
58 Novartis Investigative Site Allentown Pennsylvania United States 18104
59 Novartis Investigative Site Lansdale Pennsylvania United States 19446
60 Novartis Investigative Site Philadelphia Pennsylvania United States 19139
61 Novartis Investigative Site Pittsburgh Pennsylvania United States 15213
62 Novartis Investigative Site Pittsburgh Pennsylvania United States 15238
63 Novartis Investigative Site Charleston South Carolina United States 29412
64 Novartis Investigative Site Memphis Tennessee United States 38119
65 Novartis Investigative Site Nashville Tennessee United States 37212
66 Novartis Investigative Site Austin Texas United States 78754
67 Novartis Investigative Site Austin Texas United States 78756
68 Novartis Investigative Site DeSoto Texas United States 75115
69 Novartis Investigative Site Houston Texas United States 77007
70 Novartis Investigative Site Houston Texas United States 77030
71 Novartis Investigative Site Houston Texas United States 77042
72 Novartis Investigative Site Lake Jackson Texas United States 77566
73 Novartis Investigative Site Richmond Virginia United States 23230
74 Novartis Investigative Site Virginia Beach Virginia United States 23230
75 Novartis Investigative Site Edmonds Washington United States 98026
76 Novartis Investigative Site Seattle Washington United States 98104
77 Novartis Investigative Site Milwaukee Wisconsin United States 53226
78 Novartis Investigative Site West Allis Wisconsin United States 53227

Sponsors and Collaborators

  • Novartis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT00467402
Other Study ID Numbers:
  • CAGO178A2304
First Posted:
Apr 30, 2007
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