FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/07/035229 [Registered on: 28/07/2021] Trial Registered Prospectively
Last Modified On: 22/07/2021
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 compare the effectiveness of repeated infusions of Ketamine and Midazolam in Obsessive Compulsive disorders that have not responded to previuous treatments with medicines or psychotherapy, and to see how this relates to the Brain Dericed Neurotrophic Factor(BDNF).  
Scientific Title of Study   Effectiveness of Repeated Ketamine Infusions in Treatment Non-Responding Obsessive Compulsive Disorder And its Relation to BDNF: a Double-Blind Randomized COntrolled Trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lalchhandama Hauhnar 
Designation  Post Graduate Trainee, MD Psychiatry, Central Institute of Psychiatry (CIP) 
Affiliation  Central Institute of Psychiatry  
Address  Al Razi Hostel, Central Institute of Psychiatry (CIP), Kanke, Ranchi, Jharkhand.

Ranchi
JHARKHAND
834006
India 
Phone  8794104751  
Fax    
Email  damtea.hauhnar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Varun S Mehta 
Designation  Associate Professor of Psychiatry, Central Institute of Psychiatry (CIP) 
Affiliation  Central Institute of Psychiatry  
Address  Central Institute of Psychiatry(CIP), Kanke, Ranchi

Ranchi
JHARKHAND
834006
India 
Phone  9204858189  
Fax    
Email  vs_mehta@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Varun S Mehta 
Designation  Associate Professor of Psychiatry, Central Institute of Psychiatry (CIP) 
Affiliation  Central Institute of Psychiatry  
Address  Central Institute of Psychiatry (CIP), Kanke, Ranchi, Jharkhand.

Ranchi
JHARKHAND
834006
India 
Phone  9204858189  
Fax    
Email  vs_mehta@yahoo.co.in  
 
Source of Monetary or Material Support  
Central Institute of Psychiatry(CIP), Kanke, Ranchi, Jharkhand. 
 
Primary Sponsor  
Name  Central Institute of Psychiatry CIP 
Address  Kanke, Ranchi, Jharkhand, India. PIN: 834006 
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 
Dr Basudeb Das  Central Institute of Psychiatry  Kanke, Ranchi
Ranchi
JHARKHAND 		 919431108544

basudebdas@cipranchi.nic.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  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 
Comparator Agent  Comparator Agent: Injection MIdazolam  6 infusions of Injection Midazolam 0.045mg/kg body weight over 2 weeks. 
Intervention  Intervention:Injection Ketamine  6 infusions of Injection Ketamine 0.5 mg/kg body weight over 2 weeks. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients of either sex, aged between 21-50 years.
2. Inpatients fulfilling ICD 10-DCR diagnostic criteria for OCD but are treatment non-responders.
3. Patients giving written informed consent.  
 
ExclusionCriteria 
Details  1. Any other major co-morbid psychiatric diagnoses (except depression and mild to moderate anxiety) and substance dependence excluding nicotine & caffeine.
2. Presence of an acute/unstable medical or neurological condition.
3. Pregnancy or lactation.
4. Childhood onset OCD (age at onset <10 years) [Geller et al, 1998].
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Score on the Dimensional Yale Brown Obsessive Compulsive Scale(DY-BOCS)
Plasma BDNF levels as measured by Sandwich ELISA method 		 DY-BOCS-1 hour before and 1 hour, 4 hours and 24 hours after each infusion for 2 weeks and 4 weeeks after last infusion.
Plasma BDNF-1 day before 1sy infusion, after 3rd infusion or 1st week and after 6th infusion or 2nd week. 
 
Secondary Outcome  
Outcome  TimePoints 
Score on the Montgomery Asberg Depression Rating scale (MADRS).
Score on the Hamilton Anxiety Rating Scale(HAM-A)
Score on the Clinician-Administered Dissociative States Scale(CADSS), and
Score on the Systemic Assessment for Treatment Emergent Events(SAFTEE) 		 1 hour before and 1 hour, 4 hours and 24 hours after each infusion for 2 weeks and 4 weeeks after last infusion. 
 
Target Sample Size   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 2 
Date of First Enrollment (India)   02/08/2021 
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   Not yet published 
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-identiļ¬cation.

  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 - Any purpose.

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

  6. For how long will this data be available start date provided 31-05-2023 and end date provided 31-05-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study is a double-blind randomized controlled trial to assess and compare the effectiveness of repeated ketamine infusions and repeated midazolam infusions in treatment non-responding Obsessive Compulsive Disorder and to assess their relation with BDNF. The study will be conducted at a premiere psychiatric institute in India. The primary outcome measures will be 1) scores on the Dimensional Y-BOCS 1hour before ,and 1 hour, 4 hours and 24 hours after each infusion for 2 weeks and after 4 weeks of the last infusion, and 2) plasma levels of BDNF 1 day before 1st infusion, after the 3rd infusion/after 1st week and after the 6th infusion/after 2nd week. The secondary outcome measures will be scores on the Montgomery Asberg Depression Rating Scale, the Hamilton Anxiety Rating Scale, the Clinician Administered Dissociative State Scale and the Systemic Assessment for Treatment Emergent Events Scale, 1 hour before, and 1 hour, 4 hours and 24 hours after each infusion for 2 weeks and after 4 weeks of last infusion. 
Close