Clinical trial NCT00411242: Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
Official title: An 8-week, Randomized, Double-blind, Fixed Dosage, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy, Safety and Tolerability of Agomelatine 25 mg and 50 mg in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week, Open-label Extension (CAGO178A2302E)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder (MDD)
Keywords: agomelatine, major depressive disorder, MDD, depression
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-13
Enrollment: 503
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: TREATMENT

Brief summary: This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria
* HAM-D17 total score \> or = 22 at Screening and Baseline
* CGI-Severity score \> or = 4 at Screening and Baseline
* Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase

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
* Concomitant psychotropic medication, including herbal preparations and melatonin
* Psychotherapy of any type
* Female patients of childbearing potential who are not using effective contraception

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17)
timeFrame: 8 weeks
Secondary outcomes:
measure: To evaluate the proportion of patients who demonstrate clinical improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale
timeFrame: 8 weeks
measure: To evaluate the proportion of patients who achieve remission at Week 8, where remission is defined by a total score of < or =7 on the HAM-D17
timeFrame: 8 weeks
measure: To evaluate efficacy with respect to the proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the baseline HAM-D17 at week 8
timeFrame: 8 weeks
measure: To evaluate the change from baseline to week 8 on the subscale scores (Maier, anxiety, retardation and sleep) of the clinician-rated HAM-D17
timeFrame: 8 weeks
measure: To evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Oceanside
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Daytona Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: North Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: North Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Orlando
country: United States
facility: Novartis Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Smyrna
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Hoffman Estates
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Hoffman Estates
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Park Ridge
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Skokie
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Prairie Village
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Topeka
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Wichita
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Shreveport
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Glen Burnie
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Kenilworth
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Summit
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Toms River
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Brooklyn
country: United States
facility: Novartis Investigative Site
state: New York
city: Cedarhurst
country: United States
facility: Novartis Investigative Site
state: New York
city: Fresh Meadows
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: Staten Island
country: United States
facility: Novartis Investigative Site
state: New York
city: West Allis
country: United States
facility: Novartis Investigative Site
state: New York
city: Raleigh
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cleveland
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Toledo
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Medford
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Memphis
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Austin
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: Irving
country: United States
facility: Novartis Investigative Site
state: Texas
city: Arlington
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Bellevue
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
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Stahl SM, Fava M, Trivedi MH, Caputo A, Shah A, Post A. Agomelatine in the treatment of major depressive disorder: an 8-week, multicenter, randomized, placebo-controlled trial. J Clin Psychiatry. 2010 May;71(5):616-26. doi: 10.4088/JCP.09m05471blu. Epub 2010 Mar 23.