| CTRI Number |
CTRI/2021/09/036776 [Registered on: 23/09/2021] Trial Registered Prospectively |
| Last Modified On: |
31/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Therapeutic efficacy of oral ketamine in Depression |
|
Scientific Title of Study
|
To study the therapeutic efficacy of oral ketamine in depression |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajnish Raj |
| Designation |
Professor & Head |
| Affiliation |
Department of Psychiatry |
| Address |
Room No.1, Department Of Psychiatry, GMC and Rajindra Hospital sangrur road Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9814913599 |
| Fax |
|
| Email |
drrajnishraj03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramanpreet Kaur |
| Designation |
Senior Resident |
| Affiliation |
Department of Psychiatry |
| Address |
Room No. 7, Department Of Psychiatry, GMC and Rajindra Hospital sangrur road Patiala
Patiala
PUNJAB
147001
India |
| Phone |
7087766328 |
| Fax |
|
| Email |
dr.ramanpreet90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramanpreet Kaur |
| Designation |
Senior Resident |
| Affiliation |
Department of Psychiatry |
| Address |
Room No. 7, Department of Psychiatry, GMC and Rajindra Hospital sangrur road Patiala
Patiala
PUNJAB
147001
India |
| Phone |
7087766328 |
| Fax |
|
| Email |
dr.ramanpreet90@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMC and Rajindra Hospital Patiala |
|
|
Primary Sponsor
|
| Name |
GMC RH Patiala |
| Address |
Government Medical College Sangrur road patiala |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Ramanpreet Kaur |
GMC & RH Patiala |
Outpatient Department , Department of Psychiatry, Government Medical College sangrur road patiala
Patiala
PUNJAB |
7087766328
dr.ramanpreet90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, (2) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (3) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, (4) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral ketamine |
Cases will have 6 sessions of fixed oral dose of Ketamine, 150 mg to be given twice weekly. Sessions will be given twice weekly for 3 weeks. |
| Comparator Agent |
placebo and ketamine |
controls will be initially given 3 sessions of placebo for 1 and a half week and then 3 sessions of oral Ketamine (150 mg) for 1 and half weeks . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients aged 18-65 years with Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of major depressive episode without psychotic features.
2. Patients who will be medically stable .
3. Patients who have given written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. History of chronic psychosis or drug induced psychosis of any kind.
2. Current DSM-5 diagnosis of drug abuse/dependence in the last six months and a negative drug screen at baseline.
3. Pregnant women, lactating mothers, surgically-sterile women or women who agree to continue using applicable birth control throughout the trial. All women of child-bearing potential must have a negative urine pregnancy test.
4. History of seizures, renal insufficiency or congestive heart failure
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It will be therapeutic response ≥ 50% decrease in severity on HAM-D and improvement on BSIS, CGI (Clinical Global impression). |
Baseline, before and after each placebo session on 3rd, 6th and 9th day; before and after each ketamine session at 12th, 15th, 18th day and at 2 weeks follow-up after last ketamine session. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It will be high risk adverse effect on ADR proforma. The perceptual and dissociative changes on Clinician- Administered Dissociative States Scale (CADSS) and Improvement on GAF (Global assessment of function) scale. |
Baseline, before and after each placebo session on 3rd, 6th and 9th day; before and after each ketamine session at 12th, 15th, 18th day and at 2 weeks follow-up after last ketamine session. |
|
|
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 4 |
|
Date of First Enrollment (India)
|
01/10/2021 |
| 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="1"
Months="0"
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
Modification(s)
|
Depressive Disorder is a common mental Disorder. The aim of this study is to find the therapeutic efficacy of oral ketamine in Depressive Disorder. Depression will be diagnosed on Diagnostic and Statistical Manual for Mental Health (DSM-5). The total number of 30 patients of Depression will be taken and will be divided into two groups i.e. Group A (n=15) and Group B (n=15). Informed written valid consent will be taken. Patients will be assessed on Hamilton rating scale (HAM-D) for depressive symptoms and severity, suicidality on Beck’s Suicide Ideation Scale (BSIS) . Global assessment of functioning (GAF) Scale will be used to rate social, occupational and psychological functioning of adults. The perceptual and dissociative changes will be assessed on Clinician Administrated Dissociative States Scale (CADSS). |