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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00463242
First received: April 19, 2007
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Major Depressive Disorder
Drug: Agomelatine
Drug: paroxetine
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with MDD who achieve remission, [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to Week 8 on the total score and Anxiety subscale of the Hospital Anxiety and Depression Scale (HAD). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 501
Study Start Date: March 2007
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Paxil
Placebo Comparator: 3 Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463242

  Hide Study Locations
Locations
United States, Arizona
Novartis Investigative Site
Phoenix, Arizona, United States, 85016
United States, California
Novartis Investigative Site
National City, California, United States, 91950
Novartis Investigative Site
Orange, California, United States, 92868
Novartis Investigative Site
Pasadena, California, United States, 91105
Novartis Investigative Site
Pico Rivera, California, United States, 90660
Novartis Investigative Site
Redlands, California, United States, 92374
Novartis Investigative Site
San Diego, California, United States, 92126
Novartis Investigative Site
San Diego, California, United States, 92120
Novartis Investigative Site
Torrance, California, United States, 90502
United States, Colorado
Novartis Investigative Site
Colorado Springs, Colorado, United States, 80909
United States, Florida
Novartis Investigative Site
Boca Raton, Florida, United States, 33431
Novartis Investigative Site
Fort Myers, Florida, United States, 33912
Novartis Investigative Site
Jacksonville, Florida, United States, 32216
Novartis Investigative Site
Jacksonville, Florida, United States, 32256
Novartis Investigative Site
Miami, Florida, United States, 33143
Novartis Investigative Site
Orlando, Florida, United States, 32806
Novartis Investigative Site
Winter Park, Florida, United States, 32789
United States, Georgia
Novartis Investigative Site
Augusta, Georgia, United States, 30912
United States, Hawaii
Novartis Investigative Site
Honolulu, Hawaii, United States, 96813
United States, Illinois
Novartis Investigative Site
Joliet, Illinois, United States, 60435
United States, Kansas
Novartis Investigative Site
Overland Park, Kansas, United States, 66212
United States, Maryland
Novartis Investigative Site
Baltimore, Maryland, United States, 21205
Novartis Investigative Site
Baltimore, Maryland, United States, 21208
Novartis Investigative Site
Rockville, Maryland, United States, 20852
United States, Massachusetts
Novartis Investigative Site
Fall River, Massachusetts, United States, 02721
United States, Michigan
Novartis Investigative Site
Okemos, Michigan, United States, 48864
United States, Missouri
Novartis Investigative Site
St. Charles, Missouri, United States, 63301
Novartis Investigative Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
Novartis Investigative Site
Lincoln, Nebraska, United States, 68510
United States, New Jersey
Novartis Investigative Site
Willingboro, New Jersey, United States, 08046
United States, New York
Novartis Investigative Site
New York, New York, United States, 10024
United States, North Carolina
Novartis Investigative Site
Charlotte, North Carolina, United States, 28211
Novartis Investigative Site
Durham, North Carolina, United States, 27710
United States, Ohio
Novartis Investigative Site
Canton, Ohio, United States, 44718
United States, Oregon
Novartis Investigative Site
Corvallis, Oregon, United States, 97330
United States, Pennsylvania
Novartis Investigative Site
Erie, Pennsylvania, United States, 16506
Novartis Investigative Site
Media, Pennsylvania, United States, 19063
Novartis Investigative Site
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Novartis Investigative Site
Austin, Texas, United States, 78756
Novartis Investigative Site
Dallas, Texas, United States, 75230
Novartis Investigative Site
Friendswood, Texas, United States, 77546
Novartis Investigative Site
Houston, Texas, United States, 77008
United States, Virginia
Novartis Investigative Site
Herndon, Virginia, United States, 20170
Novartis Investigative Site
Richmond, Virginia, United States, 23230
United States, Washington
Novartis Investigative Site
Bellevue, Washington, United States, 98004
United States, Wisconsin
Novartis Investigative Site
Waukesha, Wisconsin, United States, 53188
Puerto Rico
Novartis Investigative Site
Hato Rey, Puerto Rico, 00918
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00463242     History of Changes
Other Study ID Numbers: CAGO178A2303
Study First Received: April 19, 2007
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
agomelatine, Major Depressive Disorder, MDD, depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Paroxetine
S 20098
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 17, 2014