To study the clinical effects of two drugs amitriptyline and agomelatine in major depressive disorder.
Phase 4
- Conditions
- Health Condition 1: null- MAJOR DEPRESSIVE DISORDER
- Registration Number
- CTRI/2015/04/005677
- Lead Sponsor
- MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 66
Inclusion Criteria
• Subjects diagnosed with major depressive disorder, single episode- according to Diagnostic and Statistical Manual of Mental disorders 5 (DSM 5) criteria.
• Age between 18 - 60 years.
• Subjects who give informed consent.
Exclusion Criteria
• Subjects with history of bipolar disorder, schizophrenia, schizoaffective disorder.
• Subjects with suicidal tendencies.
• Subjects with altered liver function.
• Subjects with any serious concurrent illness.
• Presence of organic brain syndrome (delirium, dementia).
• Presence of alcohol and substance abuse/dependence, epilepsy, mental retardation, pregnancy and lactation.
• Subjects who are on antidepressant medication.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. BECKS DEPRESSION INVENTORY II SCORE <br/ ><br>2. CLINICAL GLOBAL IMPRESSION- SEVERITY SCORE <br/ ><br>3. QUALITY OF SLEEP USING LEEDS QUESTIONNAIRE <br/ ><br>4. ESTIMATION OF LIVER ENZYMES: SGPT AND SGOT <br/ ><br>5. BODY MASS INDEX <br/ ><br> <br/ ><br>Timepoint: DONE AT BASELINE ( BEFORE MEDICATION ), 2ND WEEK AND 6TH WEEK
- Secondary Outcome Measures
Name Time Method 1.CLINICAL GLOBAL IMPRESSION- IMPROVEMENT SCORE <br/ ><br>2.ADVERSE DRUG EFFECTS USING UKU SIDE EFFECT SCALE <br/ ><br>3.MEDICATION COMPLIANCETimepoint: DONE AT 2ND WEEK AND 6TH WEEK