Effects of agomelatine (25 to 50 mg/day) on circadian rhythms in patients with Major Depressive Disorder.
- Conditions
- Major Depressive DisorderMedDRA version: 14.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2010-024191-25-AT
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
- Outpatients of both gender, age 18 to 60 included
- Fulfilling DSM-IV-TR criteria for Major Depressive Disorder single or recurrent episode
- Diagnosis documented using the brief structured interview MINI
- Hamilton Depression Ratin Scale: HAM-D 17 items total score > or = 22 and sum of HAM-D item 5 Insomnia: middle of the night + item 6 Insomnia early hours of the morning > or = 3
- Requiring antidepressant treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Marked suicidal intent and/or known suicidal tendencies for the current episode according to the investigator's opinion
- Any clinically relevant abnormality detected during the physical examination, ECG or laboratory test likely to interfere with the study conduct or evaluation
- Women of childbearing potential without effective contraception method
- Pregnant or breast-feeding women
- Patients not able to read or to complete self-rating questionnaires
- Hepatic impairment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assess the effect of agomelatine on the circadian rhythms in Major Depressive Disorder patients by evaluating circadian parameters.;Secondary Objective: Effects of agomelatine on depression and its acceptability;Primary end point(s): No primary criterion has been defined for this exploratory study. The following criteria will be evaluated:<br>- Circadian parameters<br>- Depressive symptoms<br>- Clinical benefit on morning condition, social functioning and daytime functioning<br>- Safety criteria<br>- Other assessments not specifically related to efficacy or safety;Timepoint(s) of evaluation of this end point: All over the study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA