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CTRI Number  CTRI/2023/05/053136 [Registered on: 25/05/2023] Trial Registered Prospectively
Last Modified On: 26/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectiveness of intramuscular ketamine with other treatment of resistance unipolar depression patients 
Scientific Title of Study   Efficacy of intramuscular ketamine as an adjunctive treatment in resistant unipolar depression-a double blind randomized placebo controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deborshi Das 
Designation  Postgraduate Tranniee 
Affiliation  Institute of Postgraduate Medical Education and Research 
Address  Institute of Psychiatry- COE Institute of Postgraduate Medical Education and Research 244- AJC bose road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  7003423081  
Fax    
Email  deborshimedico@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Sujit Sarkhel 
Designation  Professor 
Affiliation  Institute of Postgraduate Medical Education and Research 
Address  Professor- Department of Psychiatry 3rd floor-Academic Building Institute of Psychiatry- COE Institute of Postgraduate Medical Education and Research 244- AJC bose road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  9836074700  
Fax    
Email  sujitsarkhel@gmail.com  
 
Details of Contact Person
Public Query  
Name  Deborshi Das 
Designation  Postgraduate Tranniee 
Affiliation  Institute of Postgraduate Medical Education and Research 
Address  Institute of Psychiatry- COE Institute of Postgraduate Medical Education and Research 244- AJC bose road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone  7003423081  
Fax    
Email  deborshimedico@gmail.com  
 
Source of Monetary or Material Support  
Institute of Postgraduate Medical Education and Research 
 
Primary Sponsor  
Name  Institute of Postgraduate Medical Education and Research 
Address  244-AJC Bose Road Kolkata-700020 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Deborshi Das  Institute of Psychiatry-COE  Institute of Psychiatry-COE Outpatient Department Room no - 1 to 7 Institute of Postgraduate Medical Education and Research 244-AJC Bose road Kolkata- 700020
Kolkata
WEST BENGAL 		 7003423081

deborshimedico@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME&R Research Oversight Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F32||Major depressive disorder, singleepisode,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intramuscular Ketamine injection  Patients fit for ketamine injection will be kept NPM for at least 6 hours for clear fluid and 8hours for solid. 7. Bodyweight of each patient will be measured and dose will be calculated as per bodyweight that is 0.5 mg/kg bodyweight 8. The amount of drug will be delivered in intravascular route directly as intramuscular shot . 9. Proper monitoring of vitals and emergence of adverse effects will be closely monitored for atleast 2 hours 10. Within two hour of first dose of ketamine, scales such as Y-BOSC will be applied 11.One group will be given thrice a week (preferably on alternate day) ketamine for a period of 2week and another group will be given alternate day placebo ( normal saline) for a same duration along with their oral medication. 12. Following similar procedure 3 sessions of intravenous ketamine will be given in the first week and 3 sessions in second week. Thus total six sessions of intravenous ketamine will be given over a period of 2 weeks. 13. All scales y-bosc will be applied on admission, after each session of administration of ketamine, after 2weeks ,4weeks and after a period of 6 weeks from the last day of ketamine administration in subsequent follow up in all the groups. 
Comparator Agent  Placebo  30 patients from randomized allocation will be given IM Normal saline along with their oral medication 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Resistant uni-polar depression patients - patients who have diagnosed major depressive disorder according to ICD 10 by two different psychiatrist & patient who already received maximum dose of two antidepressant for 6-8 weeks  
 
ExclusionCriteria 
Details  1. Current substance abuse
2.mental retardation, pervasive developmental disorder
3. epilepsy and other neurological disorder
4. hypertension and other  
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Patients receiving intramuscular ketamine as adjuvant treatment will show better response than the patients receiving placebo   1.5 Years  
 
Secondary Outcome  
Outcome  TimePoints 
If there is any improvement in suicidal ideation  1.5yrs 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   30/05/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
BACKGROUND OF PRESENT STUDY- In recent times lots of study were conducted where Ketamine was administered through Intra venous route in target population but there are very few studies where it was administered via Intramuscular route. In a recent study it was found that Intramuscular ketamine in the dose of 0.25 mg/kg is as effective and safe as 0.5 mg/kg given either I.M. or I.V., substantially alleviating depressive symptoms within a few hours and sustained for 3 days. In order to explore feasibility of IM Ketamine as adjunctive therapy in cases of treatment resistant depression patients, we will conduct this study.

OBJECTIVE- To compare the treatment response between two groups of patients with treatment resistant depression; One group with conventional pharmacotherapy and the group with conventional pharmacotherapy along with adjunctive intramuscular ketamine.

METHODOLGY: A double blind randomised placebo controlled study will be conducted with 60 patients.All the patienet will be admitted in IOP indoor facility after fulfilling inclusion and exclusion criteria. Patients will be divided into 30 patients in each group by block randomisation and one group will get Intramuscular ketamine and another group will get normal saline as placebo along with oral medication. All the patient will be assessed by MADRS scale on day 0,7th, 14th,30th day and data will be collected and will be analysed. Assesment will be done by different psychiatrist who will not aware about the patient’s treatment protocol.

EXPECTED OUTCOME-The group who will receive Intramuscular ketamine as adjuvant treatment will show better response than the group who will get normal saline as adjuvant.
 
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