Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder

Major Depressive Disorder (MDD) 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 (CAGO178A2302E)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411242
• Other study ID #: CAGO178A2302
• Status: Completed
• Phase: Phase 3
• Start date: December 2006

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• 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. 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder (MDD)

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

External Links

•   Results for CAGO178A2302 from the Novartis Clinical Trials website