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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00411242
Other study ID # CAGO178A2302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 2006

Study information

Verified date May 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 503
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

Study Design


Intervention

Drug:
agomelatine

placebo


Locations

Country Name City State
United States Novartis Investigative Site Arlington Virginia
United States Novartis Investigative Site Atlanta Georgia
United States Novartis Investigative Site Austin Texas
United States Novartis Investigative Site Bellevue Washington
United States Novartis Investigative Site Brooklyn New York
United States Novartis Investigative Site Cedarhurst New York
United States Novartis Investigative Site Cleveland Ohio
United States Novartis Investigative Site Daytona Beach Florida
United States Novartis Investigative Site Denver Colorado
United States Novartis Investigative Site Fort Lauderdale Florida
United States Novartis Investigative Site Fresh Meadows New York
United States Novartis Investigative Site Glen Burnie Maryland
United States Novartis Investigative Site Hoffman Estates Illinois
United States Novartis Investigative Site Hoffman Estates Illinois
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Irving Texas
United States Novartis Investigative Site Kenilworth New Jersey
United States Novartis Investigative Site Las Vegas Nevada
United States Novartis Investigative Site Los Angeles California
United States Novartis Investigative Site Medford Oregon
United States Novartis Investigative Site Memphis Tennessee
United States Novartis Investigative Site Mesa Arizona
United States Novartis Investigative Site Miami Florida
United States Novartis Investigative Site Milwaukee Wisconsin
United States Novartis Investigative Site New York New York
United States Novartis Investigative Site New York New York
United States Novartis Investigative Site North Miami Florida
United States Novartis Investigative Site North Miami Florida
United States Novartis Investigative Site Oceanside California
United States Novartis Investigative Site Oklahoma City Oklahoma
United States Novartis Investigative Site Orlando Florida
United States Novartis Investigative Site Park Ridge Illinois
United States Novartis Investigative Site Philadelphia Pennsylvania
United States Novartis Investigative Site Portland Oregon
United States Novartis Investigative Site Prairie Village Kansas
United States Novartis Investigative Site Raleigh North Carolina
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site Seattle Washington
United States Novartis Investigative Site Shreveport Louisiana
United States Novartis Investigative Site Skokie Illinois
United States Novartis Investigative Site Smyrna Georgia
United States Novartis Investigative Site Staten Island New York
United States Novartis Investigative Site Summit New Jersey
United States Novartis Investigative Site Toledo Ohio
United States Novartis Investigative Site Toms River New Jersey
United States Novartis Investigative Site Topeka Kansas
United States Novartis Investigative Site West Allis New York
United States Novartis Investigative Site Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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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