Early effect of agomelatine on general interest in outpatients suffering major depressive disorder

Not Applicable

Completed

• Conditions: Depression; Mental and Behavioural Disorders; Major Depressive Disorder

• Registration Number: ISRCTN28327843
• 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: 2011-05-04
• Study Completion: 2013-03-30
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Male or female outpatients
2. Aged between 18 and 65 years (inclusive) at the time of selection
3. Fulfilling Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision (DSM-IV-TR) criteria for current major depressive episode (MDE) < = 12months, of moderate to severe intensity
4. Major depressive episode diagnosis documented using the brief structured Mini-International Neuropsychiatric Interview (M.I.N.I.)
5. Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16) item 13 (General interest) > = 2
6. Hamilton Rating Scale for Depression (HAM-D-17) total score > = 22
7. Clinical Global Impression - Severity (CGI-S) (Severity of illness) > = 4 (moderately to severely ill)
8. Requiring an antidepressant treatment

Exclusion Criteria

1. Patient fulfilling DSM-IV-TR criteria for a MDE of mild intensity or severe episode with psychotic features,catatonic features or with duration <4 weeks
2. All types of depression other than MDD, according to DSM-IV-TR criteria
3. Marked suicidal intent and/or known suicidal tendencies for the current episode defined as a score of 4 at the item 3 of the HAM-D-17 and/or in the investigator's opinion based on the patient's medical history, previoussuicide attempts, quality of social and familial support
4. Pregnancy, breastfeeding or possibility of becoming pregnant during the study and without an effective contraception
5. Hepatic impairment
6. Severe renal insufficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
General interest score obtained from the Visual Analogue Scale (VAS) reflecting the item 13 of the QIDS-SR 16 scale

Secondary Outcome Measures

Name	Time	Method
To provide additional efficacy, safety and tolerability data on agomelatine