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CTRI Number  CTRI/2024/01/060984 [Registered on: 01/01/2024] Trial Registered Prospectively
Last Modified On: 29/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of a drug Ketamine ,in treatment of patients with depression. 
Scientific Title of Study   Comparative efficacy of oral Ketamine vs. Electroconvulsive therapy in moderate to severe depression: A randomized controlled trial. 
Trial Acronym  ECT-KETAMINE RCT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Susanta Kumar Padhy 
Designation  Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Department Of Psychiatry, AIIMS Bhubaneswar, Sijua Patrapada, Odisha

Khordha
ORISSA
751019
India 
Phone  09801801184  
Fax    
Email  psych_susanta@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Susanta Kumar Padhy 
Designation  Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Department Of Psychiatry, AIIMS Bhubaneswar, Sijua Patrapada, Odisha


ORISSA
751019
India 
Phone  09801801184  
Fax    
Email  psych_susanta@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Zafar Mahmood 
Designation  Junior Resident 
Affiliation  AIIMS Bhubaneswar 
Address  Flat 1602 A Vipul Greens near AIIMS Bhubaneswar Sijua Patrapada

Khordha
ORISSA
751019
India 
Phone  09801801184  
Fax    
Email  zafar.mahmood007@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Bhubaneswar 
 
Primary Sponsor  
Name  Dr Susanta Kumar Padhy 
Address  Department of Psychiatry AIIMS Bhubaneswar Sijua Bhubaneswar Odisha 
Type of Sponsor  Other [Principal Investigator] 
 
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 
Dr Zafar Mahmood  AIIMS BHUBANESWAR  Department of Psychiatry AIIMS BBSR Sijua Patrapada
Khordha
ORISSA 		 9801801184

zafar.mahmood007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS BHUBANESWAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, (2) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, (3) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Bitemporal Electroconvulsive Therapy  Dose of Charge As per patient requirement Frequency 3 times a week Duration 2 weeks It is a somatic therapy 
Intervention  Ketamine  Oral ketamine 150–175 mg, administered thrice weekly (alternate days) for 2 weeks Route Oral 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All patients coming for treatment at the OPD and IPD of the Department of Psychiatry fulfilling the following are included:
a) People with Moderate to Severe Depressive episode according to criteria in DSM 5 and ICD 10 RCD.
b) Aged between 18 to 65 years
c) American Society of Anaesthesiologists (ASA) score of 1, 2
or stable 3
d) With Informed consent from the Legally Authorised Relative
 
 
ExclusionCriteria 
Details  a. Severe hepatic or renal impairment
b. Uncontrolled hypertension, history of significant cardiac arrhythmias, history of substance dependence, history of seizure disorder or organic brain disorder, pregnancy or breastfeeding
c. Concomitant psychotic disorder.
d. Non-Consenting
e. History of ketamine allergy
f. Receipt of ECT or ketamine in the past 6 months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
change in MADRS score  baseline and one week after completion of final intervention (Week 3) 
 
Secondary Outcome  
Outcome  TimePoints 
To compare MADRS scores between ECT and ketamine groups   Base line 1 and 2 weeks 
compare MADRS response and remission rates   Base line 1 and 2 weeks 
 
Target Sample Size
Modification(s)  		 Total Sample Size="30"
Sample Size from India="30" 
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)   05/01/2024 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [zafar.mahmood007@gmail.com].

  6. For how long will this data be available start date provided 20-02-2025 and end date provided 20-12-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The proposed study aims to conduct a randomized, controlled, parallel-group clinical trial at the Department of Psychiatry, AIIMS, Bhubaneswar. The study will include patients diagnosed with Moderate and Severe Depressive episodes based on ICD 10 (DCR) and DSM 5 criteria, who meet all the specified inclusion and exclusion criteria.Randomization will be performed using computer-generated random numbers, with an allocation ratio of 1:1, to assign the patients into two treatment groups. Sociodemographic and clinical data of the patients will be collected using predetermined forms. Baseline assessments of the patients’ MADRS (Montgomery-Ã…sberg Depression Rating Scale) scores will be conducted, and the study will be blinded to the assessors.

 

The experimental group will receive oral ketamine as the treatment, starting with a dosage of 150mg in the first session, followed by 150-175mg three times a week for a duration of 2 weeks. (22) (16)and the control group would receive bitemporal Electroconvulsive Therapy up to 3 times a week for 2 weeks. ECT is to be administered at the lowest dose that elicits a generalized seizure. Both groups treated with a fixed course of alternate day sessions thrice a week for 2 weeks (total 6 sessions). All outcome measures with assessed at baseline and at 1 week, 2 weeks, 3 weeks, and 6 weeks.

The two groups would be followed for 6 weeks, at the completion of which all the patients would be reassessed. The follow-up assessment would involve a re-evaluation of the MADRS and other assessments to see for any change. The data thus collected would be analysed, and compared within and in between the study groups and statistical tests would be applied for drawing conclusions.

 
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