Effect of Rejiyana (Acetyl-L-carnitine and Agmatine) in major depressive disorder.
- Conditions
- Health Condition 1: F331- Major depressive disorder, recurrent, moderate
- Registration Number
- CTRI/2023/07/055151
- Lead Sponsor
- Dr. G Prasad Rao
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1.Participants with HAM-D 18 and above.
2.Patients suffering from mild to severe depression.
3.18–65 Years of age, of either gender.
4.Participants with existing co-morbid condition like diabetes or hypertension are on standard treatment stable last from 6 months.
5.Willing to give signed Informed Consent.
1.Patients suffering from bipolar affective disorder, any form of schizophrenia, tuberculosis, and sarcoidosis.
2.Pregnant or lactating women.
3.Known allergy, intolerance or contraindication to study medication.
4.Women of childbearing potential not willing to utilize effective contraception. A negative human chorionic gonadotropin (HCG) pregnancy test is required.
5.Patients who has high suicidal risk (MADRS >3)
6. Patients who have significant medical disorders like hepatic insufficiency, uncontrolled diabetes, renal impairment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Sum of the Hamilton Rating Scale for Depression (17-items) (HAM-D17).Timepoint: Day 28
- Secondary Outcome Measures
Name Time Method 1.Clinicians Global Impressions (CGI) ScoreTimepoint: Day 28;2.Incidence of adverse events.Timepoint: Day 28;2.Score in Montgomery-Asberg Depression Rating Scale (MADRS)Timepoint: Day 28