| CTRI Number |
CTRI/2024/02/062696 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study improvement in patients with Obsessive Compulsive Disorder with add-on Intravenous Ketamine vs placebo |
|
Scientific Title of Study
|
To study Efficacy and safety of Add-on Intravenous Ketamine in Obsessive Compulsive Disorder : A Pilot Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aashi Srivastava |
| Designation |
PG Trainee |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Psychiatry,
KIMS,
Khordha,
751024
Odisha
India
Khordha
ORISSA
751024
India |
| Phone |
7405199118 |
| Fax |
|
| Email |
ash25.grace@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sudipta Kumar Das |
| Designation |
MD Psychiatry |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Psychiatry,
Kalinga Institute of Medical Sciences,
KIMS Campus 5
KIIT University
Khordha
751024
Odisha
India
Khordha
ORISSA
751024
India |
| Phone |
9439728347 |
| Fax |
|
| Email |
linksudipta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aashi Srivastava |
| Designation |
PG Trainee |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Psychiatry,
KIMS,
Khordha,
751024
Odisha
India
Khordha
ORISSA
751024
India |
| Phone |
7405199118 |
| Fax |
|
| Email |
ash25.grace@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences
KIIT University, Patia
Khorda
Bhubaneswar
Odisha
Pincode-751024 |
|
|
Primary Sponsor
|
| Name |
Aashi Srivastava |
| Address |
Kalinga Institute of Medical Sciences |
| 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 |
| DrAashi Srivastava |
Kalinga Institute of Medical Sciences |
Department of Psychiatry
Male and Female psychiatry Ward
E Block Basement
Kalinga Institute of Medical Sciences
KIIT University KIMS Campus 5
KIIT road patia
Khordha
751024
Odisha
Khordha
ORISSA |
7405199118
ash25.grace@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kalinga Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F422||Mixed obsessional thoughts and acts, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketamine |
Test group- 0.5 mg per kg body weight Ketamine in 50ml normal saline intravenous over 40 minutes |
| Comparator Agent |
Normal Saline |
Control group - Injection Normal Saline 50ml intravenous over 40 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Obsessive Compulsive Disorder according to ICD-10 and having Y-BOCS score more than 16
Duration more than 6 months with one failed trial of either SSRI or Clomipramine
Patients who give their consent |
|
| ExclusionCriteria |
| Details |
Patients who do not give their informed consent.
Patients with present diagnosis of cardiovascular disorders, glaucoma, raised intracranial pressure and history of head trauma
Pregnant and lactating females
Patients with current diagnosis of schizophrenia
Patients diagnosed with Mental Retardation
Patients having hypersensitivity to ketamine
Patients with diagnosis of severe depression |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of intravenous Ketamine in reducing the intensity of Obsessive Compulsive Symptoms within two weeks of administration |
To assess the effect of intravenous Ketamine in reducing the intensity of Obsessive Compulsive Symptoms
First assessment at baseline, then on every third day after receiving the infusion (day 0,day 3,day 6,day 9,day 12,day 15)
Then weekly assessment for 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess phenomenological characteristics which favour response to Ketamine
To assess safety of administration and Adverse Drug Reaction following Ketamine |
To Follow up patient using side effect checklist |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/02/2024 |
| 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="1"
Months="6"
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
|
Obsessive Compulsive Disorder is a grossly distressing disease with a long course and significant morbidity and decreased quality of life due to delay in relief of symptoms by first line treatment like selective serotonin reuptake inhibitors or Clomipramine with cognitive behavioural therapy - Exposure Response prevention. This demands for newer interventions as add on . Considering the role of the N-Methyl-D-aspartate receptor (NMDAR) and glutamatergic pathways in the pathophysiology of OCD, ketamine has emerged as a potential therapeutic option with rapid onset of action. Thus, Ketamine as add on therapy will reduce the symptoms and morbidity of Obsessive Compulsive Disorder earlier than medications alone. |