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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467402
• Other study ID #: CAGO178A2304
• Status: Completed
• Phase: Phase 3
• Start date: April 2007

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 644
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• agomelatine

• placebo

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Albuquerque	New Mexico
United States	Novartis Investigative Site	Allentown	Pennsylvania
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Beverly Hills	California
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Bradenton	Florida
United States	Novartis Investigative Site	Braintree	Massachusetts
United States	Novartis Investigative Site	Bronx	New York
United States	Novartis Investigative Site	Buffalo	New York
United States	Novartis Investigative Site	Chapel Hill	North Carolina
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Chicago	Illinois
United States	Novartis Investigative Site	Chicago	Illinois
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Coral Springs	Florida
United States	Novartis Investigative Site	Costa Mesa	California
United States	Novartis Investigative Site	DeSoto	Texas
United States	Novartis Investigative Site	Edmonds	Washington
United States	Novartis Investigative Site	Encino	California
United States	Novartis Investigative Site	Farmington Hills	Michigan
United States	Novartis Investigative Site	Fort Myers	Florida
United States	Novartis Investigative Site	Gainesville	Florida
United States	Novartis Investigative Site	Glendale	California
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Kansas City	Missouri
United States	Novartis Investigative Site	Kansas City	Missouri
United States	Novartis Investigative Site	Lake Jackson	Texas
United States	Novartis Investigative Site	Lansdale	Pennsylvania
United States	Novartis Investigative Site	Libertyville	Illinois
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Memphis	Tennessee
United States	Novartis Investigative Site	Milwaukee	Wisconsin
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	New Orleans	Louisiana
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Newark	New Jersey
United States	Novartis Investigative Site	Newport Beach	California
United States	Novartis Investigative Site	Oceanside	California
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Overland Park	Kansas
United States	Novartis Investigative Site	Peoria	Arizona
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigative Site	Rhododendron	Oregon
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	Rockville	Maryland
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Saint Petersburg	Florida
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Sherman Oaks	California
United States	Novartis Investigative Site	Temecula	California
United States	Novartis Investigative Site	Toledo	Ohio
United States	Novartis Investigative Site	Topeka	Kansas
United States	Novartis Investigative Site	Towson	Maryland
United States	Novartis Investigative Site	Towson	Maryland
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	Venice	Florida
United States	Novartis Investigative Site	Virginia Beach	Virginia
United States	Novartis Investigative Site	West Allis	Wisconsin
United States	Novartis Investigative Site	West Palm Beach	Florida
United States	Novartis Investigative Site	Wheat Ridge	Colorado
United States	Novartis Investigative Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Hamilton Depression Rating Scale total score =16 at two consecutive visits;		Primary efficacy variable is measured from randomization to relapse
Primary	hospitalization due to depression;		Primary efficacy variable is measured from randomization to relapse
Primary	suicide attempt or suicide;		Primary efficacy variable is measured from randomization to relapse
Primary	discontinuation due to lack of efficacy according to Investigator judgment.		Primary efficacy variable is measured from randomization to relapse
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Results for CAGO178A2304 from the Novartis Clinical Trials website