Effect of Rejiyana (Acetyl-L-carnitine and Agmatine) in major depressive disorder.

Not Applicable

Completed

• Conditions: Major depressive disorder, recurrent, moderate,

• Registration Number: CTRI/2023/07/055151
• Lead Sponsor: Dr. G Prasad Rao

Brief Summary

Depressioncauses important health problems and frequently co-exists with other debilitatingchronic conditions.(1)Guidelines recommend psychotherapy and selective serotonin-reuptake inhibitors(SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) for patientswith this condition. However, approximately 50% of patients do not respond tothe first-line antidepressant therapy(2),and the proportion of patients achieving a response decreases to approximately30% with second-line treatment.(3)

Acetyl-L-carnitineand Agmatine (REJIYANA®) an anti-depressant has been having evidencewith depression. Thus, more studies are in needed in patients with depression. (4)(5)

Thereare no double blind studies in India on efficacy and safety of the combinationof Acetyl-L-carnitine and Agmatine (Experimental Drug).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-25
• Study Completion: 2023-12-14
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Participants with HAM-D 18 and above.
• 2.Patients suffering from mild to severe depression.
• 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

• 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).	Day 28

Secondary Outcome Measures

Name	Time	Method
2.Score in Montgomery-Asberg Depression Rating Scale (MADRS)	Day 28
2.Incidence of adverse events.	Day 28
1.Clinicians Global Impressions (CGI) Score	Day 28

Trial Locations

Locations (1)

Asha Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Asha Hospital

🇮🇳Hyderabad, TELANGANA, India

Dr G Prasad Rao

Principal investigator

9985900005

prasad40@gmail.com