Evaluation of efficacy and clinical benefit of agomelatine in patients with major depressive disorder compared to serotonin-norepinephrine reuptake inhibitor (SNRI)

Phase 3

Completed

• Conditions: Major depressive disorder; Mental and Behavioural Disorders; Depressive episode

• Registration Number: ISRCTN96725312
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-08
• Study Completion: 2010-10-31
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 418

Inclusion Criteria

1. Aged between 18 and 65 years, either sex
2. Out-patients fulfilling Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for major depressive disorder

Exclusion Criteria

Women of childbearing potential without effective contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression (HAM-D) total score, from baseline to week 24.

Secondary Outcome Measures

Name	Time	Method
<br> 1. HAM-D items, from baseline to week 24<br> 2. Clinical Global Impression scale, from baseline to week 24<br> 3. Pittsburgh Sleep Quality Index, from baseline to week 24<br> 4. Leeds Sleep Evaluation Questionnaire, from week 1 to week W2<br> 5. Sheehan Disability Scale, from baseline to week 24<br> 6. Safety from baseline to week 24<br>