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CTRI Number  CTRI/2022/01/039257 [Registered on: 07/01/2022] Trial Registered Prospectively
Last Modified On: 06/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Multiple Ketamine infusion for Treatment Resistant Obsessive Compulsive Disorder- a placebo controlled study 
Scientific Title of Study   A randomized, double-blind placebo controlled study of clinical utility of multiple ketamine infusion in treatment resistant Obsessive Compulsive Disorder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vikhram Ramasubramanian  
Designation  Consultant Psychiatrist  
Affiliation  Ahana hospitals, LLP 
Address  Ahana hospitals, Department of psychiatry Research Division. 2nd floor, No.11.Subburam Street, Gandhi Nagar, Madurai.

Madurai
TAMIL NADU
625020
India 
Phone  9443772233   
Fax    
Email  vikhram@ahanahospitals.in  
 
Details of Contact Person
Scientific Query  
Name  Vikhram Ramasubramanian  
Designation  Consultant Psychiatrist  
Affiliation  Ahana hospitals, LLP 
Address  Ahana hospitals, Department of psychiatry Research Division. 2nd floor, No.11.Subburam Street, Gandhi Nagar, Madurai.

Madurai
TAMIL NADU
625020
India 
Phone  9443772233   
Fax    
Email  vikhram@ahanahospitals.in  
 
Details of Contact Person
Public Query  
Name  Vikhram Ramasubramanian  
Designation  Consultant Psychiatrist  
Affiliation  Ahana hospitals, LLP 
Address  Ahana hospitals, Department of psychiatry Research Division. 2nd floor, No.11.Subburam Street, Gandhi Nagar, Madurai.

Madurai
TAMIL NADU
625020
India 
Phone  9443772233   
Fax    
Email  vikhram@ahanahospitals.in  
 
Source of Monetary or Material Support  
Ahana Hospitals LLP, No.11.Subburam Street, Gandhi Nagar, Madurai-625020, Tamilnadu, India  
 
Primary Sponsor  
Name  Ahana Hospitals LLP 
Address  Ahana Hospitals LLP 11,subburam street, madurai 
Type of Sponsor  Private hospital/clinic 
 
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 
vikhram ramasubramanian   Ahana hospitals LLP   Department of psychiatry , Research division, No 11 , Subburaman street, Madurai
Madurai
TAMIL NADU 		 9443772233

vikhram@ahanahospitals.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Radianz Healthcare and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F42||Obsessive-compulsive disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ketamine infusion  This arm will receive 0.5mg/kg intravenous infusion of ketamine (on alternate days). Patients will receive 6 such infusions over the period of 2 weeks 
Comparator Agent  Midazolam  This arm will receive 0.045mg/kg repeated dose midazolam (on alternate days). Patients will receive 6 such infusions over the period of 2 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Participants must be willing to give a written informed consent document;
Participants must fulfill DSM-5 criteria for Obsessive Compulsive Disorder, and should have been resistant to at least 2 SSRI trails of adequate dose and duration and psychotherapy.
Participants must be medically and neurologically healthy.
 
 
ExclusionCriteria 
Details  Those who have neurological disorders, severe medical illness, mental retardation and co-morbid psychiatric diagnoses such as psychosis, substance dependence
Women who are pregnancy or breastfeeding
Those who are allergic to ketamine 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Outcome measures were (i) a reduction in illness severity on the YBOCS scale compared to baseline scores, and (ii) response [as defined
by ≥35 % reduction (response) and 25–35 % reduction (partial response)] on the YBOCS total score. 		 at baseline, 2 weeks, 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Outcome measures were a reduction in depression severity on the HAM-D scale compared to baseline scores.   at baseline, 2 weeks, 4 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   17/01/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Serotonin reuptake inhibitors (SRIs) and cognitive behavioural therapy- exposure and response prevention (CBT- ERP) are the first line treatment option for obsessive compulsive disorder (OCD). However, one third of the OCD patient do not respond to this treatment. This implies a need for novel pharmacological treatment option. Recently there has been considerable interest in the anti-obsessional effect of glutamate-modulating drugs such as memantine, N-acetyl cysteine and ketamine. However to the best of our knowledge, data on the use of ketamine in OCD is limited. Hence a study on the use of multiple ketamine infusions for treatment resistant OCD was conceived, based on the data available on its efficacy in patients with depression.
 
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