| CTRI Number |
CTRI/2023/07/055151 [Registered on: 12/07/2023] Trial Registered Prospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Rejiyana (Acetyl-L-carnitine and Agmatine) in major depressive disorder. |
|
Scientific Title of Study
|
A Double Blind Study to Assess Efficacy of Add-on Acetyl-L-carnitine and Agmatine over Escitalopram in Major Depressive Disorder. |
| Trial Acronym |
MDD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G Prasad Rao |
| Designation |
Principle Investigator |
| Affiliation |
Asha Hospital |
| Address |
Department of Psychiatry, Asha Hospital, Road No 14, Banjara Hills
Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
9985900005 |
| Fax |
|
| Email |
prasad40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Prasad Rao |
| Designation |
Principle Investigator |
| Affiliation |
Asha Hospital |
| Address |
Department of Psychiatry, Asha Hospital, Road No 14, Banjara Hills
Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
9985900005 |
| Fax |
|
| Email |
prasad40@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rakesh Ray |
| Designation |
Clinical Research Associate |
| Affiliation |
RYT Life Sciences |
| Address |
Clinical Trial Department, 205/1 Shilp Arcade, LBS Road, Bapunagar
Ahmedabad
Ahmadabad
GUJARAT
382345
India |
| Phone |
7778866235 |
| Fax |
|
| Email |
rakesh@rytlifesciences.com |
|
|
Source of Monetary or Material Support
|
| Dr G Prasad Rao, Department of Psychiatry, Asha Hospital, Road No 14, Banjara Hills, Hyderabad, 500034, Telangana, India |
|
|
Primary Sponsor
|
| Name |
Dr. G Prasad Rao |
| Address |
Department of Psychiatry, Asha Hospital, Road No 14, Banjara Hills, Hyderabad, 500034, Telangana, India |
| Type of Sponsor |
Other [Investigator Funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G Prasad Rao |
Asha Hospital |
Department of Psychiatry, Asha Hospital, Road No 14, Banjara Hills, Hyderabad
Hyderabad
TELANGANA |
9985900005
prasad40@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Asha Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
1 Capsule BID for 28 days |
| Intervention |
Rejiyana (Acetyl-L-carnitine and Agmatine) |
1 Capsule BID for 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Sum of the Hamilton Rating Scale for Depression (17-items) (HAM-D17). |
Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. Score in Montgomery-Asberg Depression Rating Scale (MADRS) |
Day 28 |
| 1. Clinicians Global Impressions (CGI) Score |
Day 28 |
| 2. Incidence of adverse events. |
Day 28 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/07/2023 |
| Date of Study Completion (India) |
14/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Depression
causes important health problems and frequently co-exists with other debilitating
chronic conditions.(1)
Guidelines recommend psychotherapy and selective serotonin-reuptake inhibitors
(SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) for patients
with this condition. However, approximately 50% of patients do not respond to
the first-line antidepressant therapy(2),
and the proportion of patients achieving a response decreases to approximately
30% with second-line treatment.(3)
Acetyl-L-carnitine
and Agmatine (REJIYANA®) an anti-depressant has been having evidence
with depression. Thus, more studies are in needed in patients with depression. (4)
(5)
There
are no double blind studies in India on efficacy and safety of the combination
of Acetyl-L-carnitine and Agmatine (Experimental Drug).
|