Health Condition 1: F331- Major depressive disorder, recurrent, moderate
Conditions
Interventions
Intervention1: Rejiyana (Acetyl-L-carnitine and Agmatine): 1 Capsule BID for 28 days
Control Intervention1: Placebo: 1 Capsule BID for 28 days
Sponsors
Dr. G Prasad Rao
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Sum of the Hamilton Rating Scale for Depression (17-items) (HAM-D17).Timepoint: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactRakesh Ray
Asha Hospital
Outcome results
None listed