Major Depressive Disorder Clinical Trial
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)
NCT number | NCT00411099 |
Other study ID # | CAGO178A2301 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | December 2006 |
Verified date | May 2012 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 508 |
Est. completion date | |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Novartis Investigative Site | Bayamon | |
Puerto Rico | Novartis Investigative Site | Rio Piedras | |
United States | Novartis Investigative Site | Albuquerque | New Mexico |
United States | Novartis Investigative Site | Atlanta | Georgia |
United States | Novartis Investigative Site | Atlanta | Georgia |
United States | Novartis Investigative Site | Austin | Texas |
United States | Novartis Investigative Site | Beachwood | Ohio |
United States | Novartis Investigative Site | Bennington | Vermont |
United States | Novartis Investigative Site | Bothell | Washington |
United States | Novartis Investigative Site | Bradenton | Florida |
United States | Novartis Investigative Site | Brooklyn | New York |
United States | Novartis Investigative Site | Cerritos | California |
United States | Novartis Investigative Site | Cromwell | Connecticut |
United States | Novartis Investigative Site | Dallas | Texas |
United States | Novartis Investigative Site | Dayton | Ohio |
United States | Novartis Investigative Site | El Centro | California |
United States | Novartis Investigative Site | Eugene | Oregon |
United States | Novartis Investigative Site | Farmington Hills | Michigan |
United States | Novartis Investigative Site | Garden Grove | California |
United States | Novartis Investigative Site | Hamden | Connecticut |
United States | Novartis Investigative Site | Houston | Texas |
United States | Novartis Investigative Site | Irvine | California |
United States | Novartis Investigative Site | Jacksonville | Florida |
United States | Novartis Investigative Site | Lafayette | California |
United States | Novartis Investigative Site | Little Rock | Arkansas |
United States | Novartis Investigative Site | Maitland | Florida |
United States | Novartis Investigative Site | Marietta | Georgia |
United States | Novartis Investigative Site | Midlothian | Virginia |
United States | Novartis Investigative Site | Nashville | Tennessee |
United States | Novartis Investigative Site | New York | New York |
United States | Novartis Investigative Site | North Charleston | South Carolina |
United States | Novartis Investigative Site | Overland Park | Kansas |
United States | Novartis Investigative Site | Pittsfield | Massachusetts |
United States | Novartis Investigative Site | Port Charlotte | Florida |
United States | Novartis Investigative Site | Princeton | New Jersey |
United States | Novartis Investigative Site | Rochester Hills | Michigan |
United States | Novartis Investigative Site | Rockville | Maryland |
United States | Novartis Investigative Site | Saint Peters | Missouri |
United States | Novartis Investigative Site | Salisbury | Maryland |
United States | Novartis Investigative Site | Salt Lake City | Utah |
United States | Novartis Investigative Site | San Diego | California |
United States | Novartis Investigative Site | Scottsdale | Arizona |
United States | Novartis Investigative Site | Temecula | California |
United States | Novartis Investigative Site | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Novartis |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 8 weeks | ||
Secondary | 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 | 8 weeks | ||
Secondary | 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 | 8 weeks | ||
Secondary | 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 | 8 weeks | ||
Secondary | To evaluate the change from baseline to week 8 on the subscale scores (Maier, anxiety, retardation and sleep) of the clinician-rated HAM-D17 | 8 weeks | ||
Secondary | To evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8 | 8 weeks |
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