A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00463242

Collaborator

(none)

501

Enrollment

Locations

Arms

10.7

Patients Per Site

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there will be a single follow-up visit.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Agomelatine Drug: paroxetine Drug: placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

501 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

An 8-week, Multicenter, Randomized, Double-blind, Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine 25 or 50 mg Given Once Daily in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week Open-label Treatment With Agomelatine 25 or 50 mg

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Agomelatine Dosing for each subject in this extension study began with the same dose (25 mg or 50 mg of agomelatine orally once daily) the subject was receiving at the end of Week 8, the week before this study began.	Drug: Agomelatine Either 25 mg or 50 mg agomelatine orally once daily
Active Comparator: 2	Drug: paroxetine Other Names: Paxil
Placebo Comparator: 3	Drug: placebo

Arm

Intervention/Treatment

Experimental: Agomelatine

Dosing for each subject in this extension study began with the same dose (25 mg or 50 mg of agomelatine orally once daily) the subject was receiving at the end of Week 8, the week before this study began.

Drug: Agomelatine

Either 25 mg or 50 mg agomelatine orally once daily

Active Comparator: 2

Drug: paroxetine

Other Names:

Paxil

Placebo Comparator: 3

Drug: placebo

Outcome Measures

Primary Outcome Measures

Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale [8 weeks]

Secondary Outcome Measures

To demonstrate less sexual dysfunction in patients with MDD receiving agomelatine compared to paroxetine, as measured by the change from baseline to Week 8 on the total score of the Arizona Sexual Experience Scale (ASEX). [8 weeks]
Proportion of patients who demonstrate clinical improvement where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale at Week 8. [8 weeks]
Proportion of patients with MDD who achieve remission, [8 weeks]
Change from baseline to Week 8 on the total score and Anxiety subscale of the Hospital Anxiety and Depression Scale (HAD). [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female adults, 18 through 70 years of age, inclusive
Diagnosis of Major Depressive Disorder according to DSM-IV criteria
HAM-D17 total score > or = 22 at Screening and Baseline

Exclusion Criteria:

History of non-response to paroxetine
Patients who have been previously treated with agomelatine
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
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	Phoenix	Arizona	United States	85016
2	Novartis Investigative Site	National City	California	United States	91950
3	Novartis Investigative Site	Orange	California	United States	92868
4	Novartis Investigative Site	Pasadena	California	United States	91105
5	Novartis Investigative Site	Pico Rivera	California	United States	90660
6	Novartis Investigative Site	Redlands	California	United States	92374
7	Novartis Investigative Site	San Diego	California	United States	92120
8	Novartis Investigative Site	San Diego	California	United States	92126
9	Novartis Investigative Site	Torrance	California	United States	90502
10	Novartis Investigative Site	Colorado Springs	Colorado	United States	80909
11	Novartis Investigative Site	Boca Raton	Florida	United States	33431
12	Novartis Investigative Site	Fort Myers	Florida	United States	33912
13	Novartis Investigative Site	Jacksonville	Florida	United States	32216
14	Novartis Investigative Site	Jacksonville	Florida	United States	32256
15	Novartis Investigative Site	Miami	Florida	United States	33143
16	Novartis Investigative Site	Orlando	Florida	United States	32806
17	Novartis Investigative Site	Winter Park	Florida	United States	32789
18	Novartis Investigative Site	Augusta	Georgia	United States	30912
19	Novartis Investigative Site	Honolulu	Hawaii	United States	96813
20	Novartis Investigative Site	Joliet	Illinois	United States	60435
21	Novartis Investigative Site	Overland Park	Kansas	United States	66212
22	Novartis Investigative Site	Baltimore	Maryland	United States	21205
23	Novartis Investigative Site	Baltimore	Maryland	United States	21208
24	Novartis Investigative Site	Rockville	Maryland	United States	20852
25	Novartis Investigative Site	Fall River	Massachusetts	United States	02721
26	Novartis Investigative Site	Okemos	Michigan	United States	48864
27	Novartis Investigative Site	Saint Charles	Missouri	United States	63301
28	Novartis Investigative Site	Saint Louis	Missouri	United States	63141
29	Novartis Investigative Site	Lincoln	Nebraska	United States	68510
30	Novartis Investigative Site	Willingboro	New Jersey	United States	08046
31	Novartis Investigative Site	New York	New York	United States	10024
32	Novartis Investigative Site	Charlotte	North Carolina	United States	28211
33	Novartis Investigative Site	Durham	North Carolina	United States	27710
34	Novartis Investigative Site	Canton	Ohio	United States	44718
35	Novartis Investigative Site	Corvallis	Oregon	United States	97330
36	Novartis Investigative Site	Erie	Pennsylvania	United States	16506
37	Novartis Investigative Site	Media	Pennsylvania	United States	19063
38	Novartis Investigative Site	Philadelphia	Pennsylvania	United States	19104
39	Novartis Investigative Site	Austin	Texas	United States	78756
40	Novartis Investigative Site	Dallas	Texas	United States	75230
41	Novartis Investigative Site	Friendswood	Texas	United States	77546
42	Novartis Investigative Site	Houston	Texas	United States	77008
43	Novartis Investigative Site	Herndon	Virginia	United States	20170
44	Novartis Investigative Site	Richmond	Virginia	United States	23230
45	Novartis Investigative Site	Bellevue	Washington	United States	98004
46	Novartis Investigative Site	Waukesha	Wisconsin	United States	53188
47	Novartis Investigative Site	Hato Rey		Puerto Rico	00918