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NCT00463242 Clinical Trial

A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)

Major Depressive Disorder Clinical Trial

Official title:
An 8-week, Multicenter, Randomized, Double-blind, Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine 25 or 50 mg Given Once Daily in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week Open-label Treatment With Agomelatine 25 or 50 mg

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00463242
Other study ID # CAGO178A2303
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2007

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 evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there will be a single follow-up visit.

Recruitment information / eligibility
Status Completed
Enrollment 501
Est. completion date
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Male and female adults, 18 through 70 years of age, inclusive - Diagnosis of Major Depressive Disorder according to DSM-IV criteria - HAM-D17 total score > or = 22 at Screening and Baseline Exclusion Criteria: - History of non-response to paroxetine - Patients who have been previously treated with agomelatine - 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 - Use of any psychoactive medication after the screening visit - Female patients of childbearing potential who are not using effective contraception Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Agomelatine
Either 25 mg or 50 mg agomelatine orally once daily
• paroxetine

• placebo

Locations
Country Name City State
Puerto Rico Novartis Investigative Site Hato Rey
United States Novartis Investigative Site Augusta Georgia
United States Novartis Investigative Site Austin Texas
United States Novartis Investigative Site Baltimore Maryland
United States Novartis Investigative Site Baltimore Maryland
United States Novartis Investigative Site Bellevue Washington
United States Novartis Investigative Site Boca Raton Florida
United States Novartis Investigative Site Canton Ohio
United States Novartis Investigative Site Charlotte North Carolina
United States Novartis Investigative Site Colorado Springs Colorado
United States Novartis Investigative Site Corvallis Oregon
United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Durham North Carolina
United States Novartis Investigative Site Erie Pennsylvania
United States Novartis Investigative Site Fall River Massachusetts
United States Novartis Investigative Site Fort Myers Florida
United States Novartis Investigative Site Friendswood Texas
United States Novartis Investigative Site Herndon Virginia
United States Novartis Investigative Site Honolulu Hawaii
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Jacksonville Florida
United States Novartis Investigative Site Jacksonville Florida
United States Novartis Investigative Site Joliet Illinois
United States Novartis Investigative Site Lincoln Nebraska
United States Novartis Investigative Site Media Pennsylvania
United States Novartis Investigative Site Miami Florida
United States Novartis Investigative Site National City California
United States Novartis Investigative Site New York New York
United States Novartis Investigative Site Okemos Michigan
United States Novartis Investigative Site Orange California
United States Novartis Investigative Site Orlando Florida
United States Novartis Investigative Site Overland Park Kansas
United States Novartis Investigative Site Pasadena California
United States Novartis Investigative Site Philadelphia Pennsylvania
United States Novartis Investigative Site Phoenix Arizona
United States Novartis Investigative Site Pico Rivera California
United States Novartis Investigative Site Redlands California
United States Novartis Investigative Site Richmond Virginia
United States Novartis Investigative Site Rockville Maryland
United States Novartis Investigative Site Saint Charles Missouri
United States Novartis Investigative Site Saint Louis Missouri
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site Torrance California
United States Novartis Investigative Site Waukesha Wisconsin
United States Novartis Investigative Site Willingboro New Jersey
United States Novartis Investigative Site Winter Park Florida

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 Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale 8 weeks
Secondary To demonstrate less sexual dysfunction in patients with MDD receiving agomelatine compared to paroxetine, as measured by the change from baseline to Week 8 on the total score of the Arizona Sexual Experience Scale (ASEX). 8 weeks
Secondary Proportion of patients who demonstrate clinical improvement where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale at Week 8. 8 weeks
Secondary Proportion of patients with MDD who achieve remission, 8 weeks
Secondary Change from baseline to Week 8 on the total score and Anxiety subscale of the Hospital Anxiety and Depression Scale (HAD). 8 weeks
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