Efficacy and safety of agomelatine in MDD

Phase 3

Completed

Conditions: Health Condition 1: null- Major Depressive Disorder

Registration Number: CTRI/2010/091/006081

Lead Sponsor: INSTITUT DE RECHERCHES INTERNATIONALES SERVIER IRIS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

Adult Indian male and female out-patients aged between 18 to 65 years of age fulfilling the DSN-IV-TR criteria for MDD of moderate to severe intensity documented using the brief structured interview MINI.

HAM-D-17 total score greater than or equal to 22

CGI-S greater than or equal to 4

Hospital Anxiety Depression Scale HAD depression sub-score greater than or equal to 11

Sheehan disability scale: SDS auto-completed

Requiring antidepressant treatment but able to go untreated until the inclusion visit

A physical examination free of any clinicaly relevant abnormality likely to interfere with the study conduct or assessment

Patients must be able to read and understand and be able to complete self-rating questionnaire

Exclusion Criteria

Patients not able to read or to complete self-rating questionnaire
Patients unlikely to co-operate in the study
Hospitalised patients
Patients with an anticipated poor compliance
Shift workers
Pregnancy, breastfeeding or possibility of becoming pregnant duirng the study period without an effective contraception
Participation in another study at the same time or within 3 months prior to the selection or patient having already been selected in the study
patients known to be non-responders to sertraline or agomelatine treatment or resistant to sertraline or agomelatine for the current episode
patient stabilised by an antidepressant for the current episode
Patient under acupuncture or following traditional Indian medicine for the current episode.
All types of depression other than the MDD such as Bipolar disorder I and II, Dysthymic Disorder, Double Depression, Chronic depression, Schizoaffective Disorder of depressive type, depression with psychotic features, resistant depression, marked suicidal intent and/or known suicidal tendencies for the current episode defined as score 4 at the item 3 of the HAM-D 17 or the investigator's opinion based on the patient's medical history, previous suicide attempts, quality of social and familial support
Patient treated with ECT or TMS within the last three months before selection or requiring ECT at present
Insight-oriented and structured psychotherapy started within the 3 months before selection
light therapy received within 2 weeks before selection
Patients meeting DSM-IV-TRdiagnosis of current Panic Disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, Acute Stress Disorder
Patients with acute or chronic psychosis,
patients with personality disorders,
Alcohol or drug abuse or dependence within past 12 months before selection
Delirium or dementia according to DSM-IV-TR
Current diagnosis of neurological disorders e.g. stroke, seizures, migraine etc.
Severe or uncontrolled organic disease likely to interfere with the conduct of the study
Hypo or hyprethyroidism except if the treatment has been stabilized for at least 3 months
Patients with hepatic impairment
Known clinically significant abnormality of biological tests likely to interfere with the conduct of the study
Known blood ALAT, ASAT or total bilirubin values greater than or equal to 2 times the upper limit
Known alkaline phosphatase values greater than or eqal to 3 times the upper normal limit
Positive hepatitis A, B, C, screening not explained by vaccination or by a past resolved infection
Known hypersensitivity to agomelatine or sertraline or any of the excipients
Inability to tolerate lactose