Clinical trial NCT00463242: 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)
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 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: 2007-04-20
Enrollment: 501
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 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.


Eligibility 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

Primary outcomes:
measure: Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: 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).
timeFrame: 8 weeks
measure: 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.
timeFrame: 8 weeks
measure: Proportion of patients with MDD who achieve remission,
timeFrame: 8 weeks
measure: Change from baseline to Week 8 on the total score and Anxiety subscale of the Hospital Anxiety and Depression Scale (HAD).
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: National City
country: United States
facility: Novartis Investigative Site
state: California
city: Orange
country: United States
facility: Novartis Investigative Site
state: California
city: Pasadena
country: United States
facility: Novartis Investigative Site
state: California
city: Pico Rivera
country: United States
facility: Novartis Investigative Site
state: California
city: Redlands
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: Torrance
country: United States
facility: Novartis Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Boca Raton
country: United States
facility: Novartis Investigative Site
state: Florida
city: Fort Myers
country: United States
facility: Novartis Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Novartis Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Orlando
country: United States
facility: Novartis Investigative Site
state: Florida
city: Winter Park
country: United States
facility: Novartis Investigative Site
state: Florida
city: Augusta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Honolulu
country: United States
facility: Novartis Investigative Site
state: Hawaii
city: Joliet
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Overland Park
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Rockville
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Fall River
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Okemos
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Saint Charles
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Lincoln
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Willingboro
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Durham
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Canton
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Corvallis
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Erie
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Media
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Austin
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Friendswood
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Herndon
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Bellevue
country: United States
facility: Novartis Investigative Site
state: Washington
city: Waukesha
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Hato Rey
country: Puerto Rico
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: