To compare the efficacy of escitalopram versus escitalopram and melatonin combination therapy in treating major depressive disorder.
Phase 4
- Conditions
- Health Condition 1: F329- Major depressive disorder, singleepisode, unspecified
- Registration Number
- CTRI/2024/07/070641
- Lead Sponsor
- Indira Gandhi Medical College Shimla
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients diagnosed with MDD but without history of insomnia according to DSM V criteria.
2.Patients of either sexes above 18 years of age.
Exclusion Criteria
1.Patients with organic cause of depression such as stroke, Alzheimer’s, Parkinsons, intracranial tumors, epilepsy etc.
2.Patients with severe depressive episodes with psychotic symptoms.
3.Pregnant and lactating females.
4.Patients in which these medications are contraindicated
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To compare the efficacy of combination therapy of escitalopram and melatonin versus escitalopram alone in the treatment of MDD using Hamilton Depression Rating Scale (HDRS). <br/ ><br>2.To compare the safety of the combination therapy of escitalopram and melatonin versus escitalopram monotherapy using AE (Adverse Event) and ADR (Adverse Drug Reaction) in adult patients of MDD. <br/ ><br>Timepoint: 3 months and 6 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method To assess the quality of life of patients of MDD taking escitalopram versus escitalopram and melatonin combination therapy using WHO BREF questionnaire.Timepoint: 3 months and 6 months