Clinical trial NCT00467402: Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: agomelatine, Major Depressive Disorder, MDD, depression
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-04-30
Enrollment: 644
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to relapse, where relapse is defined by the occurrence of any one of the following:
timeFrame: Primary efficacy variable is measured from randomization to relapse
measure: Hamilton Depression Rating Scale total score ≥16 at two consecutive visits;
timeFrame: Primary efficacy variable is measured from randomization to relapse
measure: hospitalization due to depression;
timeFrame: Primary efficacy variable is measured from randomization to relapse
measure: suicide attempt or suicide;
timeFrame: Primary efficacy variable is measured from randomization to relapse
measure: discontinuation due to lack of efficacy according to Investigator judgment.
timeFrame: Primary efficacy variable is measured from randomization to relapse
Secondary outcomes:
measure: 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.
timeFrame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
measure: Proportion of patients experiencing relapse during the double-blind continuation phase.
timeFrame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
measure: 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.
timeFrame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
measure: Change from randomization to the end of the double-blind continuation phase, on the Hospital Anxiety and Depression (HAD) total score and subscale scores.
timeFrame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Peoria
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Beverly Hills
country: United States
facility: Novartis Investigative Site
state: California
city: Costa Mesa
country: United States
facility: Novartis Investigative Site
state: California
city: Encino
country: United States
facility: Novartis Investigative Site
state: California
city: Glendale
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Newport Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Oceanside
country: United States
facility: Novartis Investigative Site
state: California
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: Sherman Oaks
country: United States
facility: Novartis Investigative Site
state: California
city: Temecula
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facility: Novartis Investigative Site
state: California
city: Wheat Ridge
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Bradenton
country: United States
facility: Novartis Investigative Site
state: Florida
city: Coral Springs
country: United States
facility: Novartis Investigative Site
state: Florida
city: Fort Myers
country: United States
facility: Novartis Investigative Site
state: Florida
city: Gainesville
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facility: Novartis Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Novartis Investigative Site
state: Florida
city: Saint Petersburg
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facility: Novartis Investigative Site
state: Florida
city: Venice
country: United States
facility: Novartis Investigative Site
state: Florida
city: West Palm Beach
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facility: Novartis Investigative Site
state: Florida
city: Atlanta
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facility: Novartis Investigative Site
state: Georgia
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Libertyville
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facility: Novartis Investigative Site
state: Illinois
city: Overland Park
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facility: Novartis Investigative Site
state: Kansas
city: Topeka
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facility: Novartis Investigative Site
state: Kansas
city: New Orleans
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facility: Novartis Investigative Site
state: Louisiana
city: Rockville
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facility: Novartis Investigative Site
state: Maryland
city: Towson
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facility: Novartis Investigative Site
state: Maryland
city: Towson
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facility: Novartis Investigative Site
state: Maryland
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Braintree
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Worcester
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Farmington Hills
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Kansas City
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Kansas City
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Newark
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facility: Novartis Investigative Site
state: New Jersey
city: Albuquerque
country: United States
facility: Novartis Investigative Site
state: New Mexico
city: Bronx
country: United States
facility: Novartis Investigative Site
state: New York
city: Buffalo
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Chapel Hill
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Raleigh
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cleveland
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Toledo
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Rhododendron
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Allentown
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Lansdale
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Memphis
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Nashville
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facility: Novartis Investigative Site
state: Tennessee
city: Austin
country: United States
facility: Novartis Investigative Site
state: Texas
city: Austin
country: United States
facility: Novartis Investigative Site
state: Texas
city: DeSoto
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Lake Jackson
country: United States
facility: Novartis Investigative Site
state: Texas
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Virginia Beach
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Edmonds
country: United States
facility: Novartis Investigative Site
state: Washington
city: Seattle
country: United States
facility: Novartis Investigative Site
state: Washington
city: Milwaukee
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: West Allis
country: United States
facility: Novartis Investigative Site
state: Wisconsin
Study officials:
References: