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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411099
• Other study ID #: CAGO178A2301
• 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: 508
• 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

Intervention

Drug:
• agomelatine

• placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

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

External Links

•   Results for CAGO178A2301 from the Novartis Clinical Trials website