Comparison of efficacy and safety of agomelatin and escitalopram in patients of major depressive disorder.

Phase 4

Completed

Conditions: Health Condition 1: null- major depressive disorder patients

Registration Number: CTRI/2014/08/004904

Lead Sponsor: Government Medical College

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

i) Age should be between 18-65 years with normal liver function.

ii) Patient should be newly diagnosed of Major Depressive Disorder(MDD)-Patient who first time consult psychiatrist for the complaints suggestive of Major Depressive Disorder(MDD).

iii) Patient is willing to give written informed consent.

Exclusion Criteria

i) Pregnant and Nursing Women

ii)Patientâ??s on other antidepressants.

iii)Patient with high risk of suicide or previous suicide attempt within 6 months, bipolar disorder, anxiety symptoms such as panic attacks, obsessive-compulsive disorder, posttraumatic stress disorder, drug abuse or dependency, previous depression resistant to antidepressants, and treatment with electroconvulsive therapy within 3 months or formal psychotherapy within 1 month.

iv)Patient with neurologic disorders (dementia, seizures, stroke), obesity with functional impairment, serious or not stabilized organic disorders (neoplasia, cardiovascular, pulmonary, uncontrolled type 1 or 2 diabetes)

v)Patient with â??resistant depressionâ?? defined as patients who have not responded to two different previous antidepressant treatment for at least four weeks at an appropriate dose.[9]

v)Shift workers, women without effective contraception

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to compare the clinical efficacy of Agomelatine with Escitalopram in the treatment of major depressive disorder.Timepoint: Total duration :- 24 weeks with follow up at 2nd week then 6th week, 10th week, 14th week, 18th week, 22th week and 24th week

Secondary Outcome Measures