| CTRI Number |
CTRI/2024/05/066840 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to assess the effects of antidepressant drugs on orexin in patients with major depressive disorder |
|
Scientific Title of Study
|
Correlation of antidepressant therapy with orexinergic pathway integrating targeted metabolomics in patients with major depressive disorder: A longitudinal 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 KH Reeta |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Professor
Department of Pharmacology
All India Institute of Medical Sciences
New Delhi
South
DELHI
110029
India |
| Phone |
01126583282 |
| Fax |
26588663 |
| Email |
reetakh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vani Viswanathan |
| Designation |
PhD student |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
PhD student
Department of Pharmacology
All India Institute of Medical Sciences
New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
vav.viswanathan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KH Reeta |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Professor
Department of Pharmacology
All India Institute of Medical Sciences
New Delhi
South
DELHI
110029
India |
| Phone |
01126583282 |
| Fax |
26588663 |
| Email |
reetakh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research (DHR)
2nd floor, IRCS Building,
1, Red Cross Road, New Delhi-110001
India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences,
Ansari Nagar
New Delhi-110029
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 KH Reeta |
All India Institute of Medical Sciences |
Department of Pharmacology,
Teaching Block,
All India Institute of Medical Sciences
New Delhi-110029
South
DELHI |
01126583282
26588663
reetakh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi |
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 |
| Intervention |
Escitalopram |
10 mg OD for 6-12 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult males or females aged 18 to 65 with the diagnosis of Major Depressive Disorder (MDD)
2. Patients who are drug naive or have started on antidepressant therapy for less than 2 weeks
|
|
| ExclusionCriteria |
| Details |
Patients with any known neurological or any systemic disorders known to cause major depressive disorder
Patients with any other psychiatric illness and substance use disorders
Pregnant and lactating women
Patients not willing to give informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean serum orexin
|
At baseline and 6-12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Orexin and BDNF gene variants
Mean Montgomery Asberg Depression rating score
Mean PSQI sleep score
Mean MoCA score
Mean serum orexin
Mean serum BDNF
Metabolomic profile mean metabolite levels |
Week 1 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="2"
Months="0"
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
|
Impaired orexin activity can contribute to depressive behaviour. However, how orexin and BDNF levels and their gene variants affect sleep, cognition and metabolomic profile in major depressive disorder patients on antidepressant therapy has not been established.
The present study will give an insight into any change in the serum orexin levels and genetic polymorphisms in orexin gene at baseline and after a minimum of 6 weeks antidepressant therapy in patients with major depressive disorder. Also, how orexin and its gene variants variants affect sleep cycle, cognition and metabolomic profile and its correlation with BDNF in patients with major depressive disorder on antidepressant therapy will be depicted. The study delineates if the treatment outcome with antidepressants is altered in patients with different variants of orexin and BDNF genes. |