Health Condition 1: null- Major Depressive Disorder
Conditions
Interventions
Intervention1: agomelatine: 25 mg - 50 mg once daily
Maximum total duration of therapy 8 weeks
Control Intervention1: sertraline: 50 mg to 100 mg OD
Maximum total duration of therapy 8 weeks
Sponsors
INSTITUT DE RECHERCHES INTERNATIONALES SERVIER IRIS
Serdia Pharmaceuticals India Pvt Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Criteria based on HAM-D-17 score; full analysis set in the change from baseline to last post-baseline valueTimepoint: Week 0 - Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| CGI severity of illness and Global improvement scores, HAM-A Psychic anxiety and Somatic anxiety scores and total score, HAD Depression and anxiety scores, SDS work, Social life and family life/home responsibilities scores, LSEQ getting off to sleep, Quality of sleep, sleep awakening and integrity of behaviour scores and safety measurementsTimepoint: Week 0, week 8 | — |
Countries
India
Contacts
Public ContactDR Ajaykumar Yadav
SERDIA PHARMACEUTICALS (INDIA) PVT. LTD.
Outcome results
None listed