| CTRI Number |
CTRI/2024/07/070641 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy of escitalopram versus escitalopram and melatonin combination therapy in treating major depressive disorder. |
|
Scientific Title of Study
|
Comparative Efficacy of Escitalopram Monotherapy and Escitalopram-Melatonin Combination Therapy in Treating Major Depressive Disorder-A Randomized Interventional Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakshi Sharma |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College, Shimla (H.P.) |
| Address |
Room no 618,Department of Pharmacology, Indira Gandhi Medical College, Shimla, H.P. 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
09816583267 |
| Fax |
|
| Email |
shootingstars1495@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P.K. Kaundal |
| Designation |
Professor and Head |
| Affiliation |
Indira Gandhi Medical College, Shimla (H.P.) |
| Address |
Room 601,Department of Pharmacology, Indira Gandhi Medical College, Shimla, H.P. 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9816120050 |
| Fax |
|
| Email |
pkkaundal66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi Sharma |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College, Shimla (H.P.) |
| Address |
Room no 618,Department of Pharmacology, Indira Gandhi Medical College, Shimla, H.P. 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
09816583267 |
| Fax |
|
| Email |
shootingstars1495@gmail.com |
|
|
Source of Monetary or Material Support
|
| 5th floor, Department of Pharmacology, Indira Gandhi Medical College, Shimla, H.P., India. |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College Shimla |
| Address |
5th floor, Department of Pharmacology, Indira Gandhi Medical College, Shimla, H.P., India. |
| Type of Sponsor |
Government medical college |
|
|
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 Sakshi Sharma |
Indira Gandhi Medical College, Shimla |
Room no 618, 5th floor, Department of Pharmacology, Indira Gandhi Medical College, Shimla, H.P., India, 171001.
Shimla
HIMACHAL PRADESH |
09816583267
shootingstars1495@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira Gandhi Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Escitalopram |
Tab Escitalopram 10 mg once daily in the morning for a total duration of 6 months |
| Intervention |
Escitalopram and Melatonin |
Tab Escitalopram 10 mg once daily in the morning and Tab Melatonin 3mg at night for total duration of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with MDD but without history of insomnia according to DSM V criteria.
2. Patients of either sexes above 18 years of age.
|
|
| ExclusionCriteria |
| Details |
1. Patients with organic cause of depression such as stroke, Alzheimer’s, Parkinsons, intracranial tumors, epilepsy etc.
2. Patients with severe depressive episodes with psychotic symptoms.
3. Pregnant and lactating females.
4. Patients in which these medications are contraindicated
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the efficacy of combination therapy of escitalopram and melatonin versus escitalopram alone in the treatment of MDD using Hamilton Depression Rating Scale (HDRS).
2. To compare the safety of the combination therapy of escitalopram and melatonin versus escitalopram monotherapy using AE (Adverse Event) and ADR (Adverse Drug Reaction) in adult patients of MDD.
|
3 months and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the quality of life of patients of MDD taking escitalopram versus escitalopram and melatonin combination therapy using WHO BREF questionnaire. |
3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Currently the efficacy of depression therapy is limited due to the need of long term treatment and variation in symptom presentation. The large treatment refractory patients indicates the need to explore additional anti depressants treatments with fewer side effects. Hence this study aims at studying the antidepressant role of melatonin as add on drug. Till date no study had been conducted comparing the efficacy and safety of escitalopram melatonin combination versus escitalopram monotherapy in major depressive disorder. |