| CTRI Number |
CTRI/2025/02/081238 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of oral ketamine in treatment resistant depression |
|
Scientific Title of Study
|
Efficacy and safety of repeated oral ketamine in treatment resistant depression |
| 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 Neha Dhanda |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Psychiatry, Jawaharlal Nehru Medical College, AMU Campus, Medical Road
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8178558028 |
| Fax |
|
| Email |
dhandaneha97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammed Reyazuddin |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College And Hospital |
| Address |
Department of Psychiatry, Jawaharlal Nehru Medical College, AMU Campus, Medical Road
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9997258800 |
| Fax |
|
| Email |
reyaz39@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammed Reyazuddin |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College And Hospital |
| Address |
Department of Psychiatry, Jawaharlal Nehru Medical College, AMU Campus, Medical Road
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9997258800 |
| Fax |
|
| Email |
reyaz39@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College ,Aligarh Muslim University, Medical College Road , AMU Campus , Aligarh ,UP, INDIA PIN CODE: 202002 |
|
|
Primary Sponsor
|
| Name |
Dr Neha Dhanda |
| Address |
Department of Psychiatry , Jawaharlal Nehru Medical College, AMU Campus, Medical Road, Aligarh,UP, INDIA, PIN 202002 |
| Type of Sponsor |
Other [Self] |
|
|
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 Neha Dhanda |
Jawaharlal Nehru Medical College and Hospital |
Department of Psychiatry ,Jawaharlal Nehru Medical College , AMU Campus , Medical Road , Aligarh 202002 , Aligarh , UTTAR PRADESH
Aligarh
UTTAR PRADESH |
8178558028
dhandaneha97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Regd.),Jawaharlal Nehru Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ketamine 1mg/kg |
Group2 will be given low dose oral ketamine (1mg/kg of body weight in 50 ml water to gulp over 3-5 minutes) thrice in a week(Day1, 3, 5) for 4weeks |
| Intervention |
Ketamine 3mg/kg |
Group1 will be given high dose oral ketamine (3mg/kg of body weight in 50 ml of water to gulp over 3-5 minutes) thrice in a week(Day1, 3, 5) for 4weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who will meet the ICD 10 criteria for Major Depressive Disorder.
2. Subjects who score more than 12 (moderate to severe) on Hamilton Depression Rating Scale.
3. Subjects who got no adequate response with 2 antidepressants.
4. Subjects who will give informed consent for this study.
|
|
| ExclusionCriteria |
| Details |
1.Subjects who will not give informed consent for study.
2. Subjects having any contraindication to administration of ketamine.
3. Subjects having any other psychiatric or physical comorbidities.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A change of 50% in HAM-D score will be considered as response. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To see comparative effectiveness in both groups.
2. To see the tolerability and adverse effects in both groups.
3. To see the development of ketamine dependence in both groups.
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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 Applicable |
| 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
|
50 patients of depression fulfilling inclusion and exclusion criteria will be recruited from Psychiatry OPD after making the diagnosis of treatment resistant depression by Consultant Psychiatrist at JNMCH, Aliagrh. They will be assessed on a semi structured proforma which includes socio-demographic details, brief clinical history, mental status examination and physical examination. The severity of Depression will be assessed using Hamilton Depression Rating Scale. After assessment patients will be randomised into 2 groups (Group 1 and Group 2) using computer generated randomisation. Group1 will be given high dose oral ketamine (3mg/kg of body weight in 50 ml of water to gulp over 3-5 minutes) and Group2 will be given low dose oral ketamine (1mg/kg of body weight in 50 ml water to gulp over 3-5 minutes).During the procedure their vitals and any other adverse effect will be monitored for 4 hours. Ketamine will be given thrice a week for 3 weeks, then the patients will be assessed again on HAM-D at 1,3 weeks and will be followed up to 3 months. This study aims to evaluate the efficacy of repeated oral ketamine as an add on treatment in treatment resistant depression with secondary objectives of comparing the efficacy of oral Ketamine at different doses and comparing the safety and adherence to repeated oral ketamine treatment. |