Clinical trial NCT00411099: 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 (CAGO178A2301E)
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: 2006-12-13
Enrollment: 508
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: To evaluate the 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: Scottsdale
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Little Rock
country: United States
facility: Novartis Investigative Site
state: Arkansas
city: Cerritos
country: United States
facility: Novartis Investigative Site
state: California
city: El Centro
country: United States
facility: Novartis Investigative Site
state: California
city: Garden Grove
country: United States
facility: Novartis Investigative Site
state: California
city: Irvine
country: United States
facility: Novartis Investigative Site
state: California
city: Lafayette
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: Temecula
country: United States
facility: Novartis Investigative Site
state: California
city: Cromwell
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Hamden
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Bradenton
country: United States
facility: Novartis Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Novartis Investigative Site
state: Florida
city: Maitland
country: United States
facility: Novartis Investigative Site
state: Florida
city: Port Charlotte
country: United States
facility: Novartis Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Marietta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Overland Park
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Rockville
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Salisbury
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Pittsfield
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Farmington Hills
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Rochester Hills
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Saint Peters
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Princeton
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Albuquerque
country: United States
facility: Novartis Investigative Site
state: New Mexico
city: Brooklyn
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Beachwood
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Dayton
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Tulsa
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Eugene
country: United States
facility: Novartis Investigative Site
state: Oregon
city: North Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Austin
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Novartis Investigative Site
state: Utah
city: Bennington
country: United States
facility: Novartis Investigative Site
state: Vermont
city: Midlothian
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Bothell
country: United States
facility: Novartis Investigative Site
state: Washington
city: Bayamon
country: Puerto Rico
facility: Novartis Investigative Site
city: Rio Piedras
country: Puerto Rico
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: