| CTRI Number |
CTRI/2025/03/081539 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Assessment Of Rapid Antidepressant Effect Of Oral Ketamine As An Adjuvant In Severe Depression |
|
Scientific Title of Study
|
ASSESSMENTENT OF RAPID ANTIDEPRESSANT EFFECT OT ORAL KETAMINE AS AN ADJUVANT IN
SEVERE DEPRESSION -A SINGLE BLIND RANDOMISED 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 |
DR SAUMYA MISHRA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JNMC MEDICAL COLLEGE,KLE |
| Address |
Department Of Psychiatry
Opd 15 ,Jnmc Kle University , Belagavi, Karnataka
Department Of Psychiatry
Opd 15 ,Jnmc Kle University , Belagavi, Karnataka
Belgaum
KARNATAKA
590019
India |
| Phone |
9793888829 |
| Fax |
|
| Email |
MISHRA8SAUMYAA@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SS CHATE |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT OF PSYCHIATRY |
| Affiliation |
JNMC MEDICAL COLLEGE,KLE |
| Address |
DEPARTMENT OF PSYCHIATRY,OPD 15,
JNMC KLE University, Belagavi, Karnataka
DEPARTMENT OF PSYCHIATRY,OPD 15,
JNMC KLE University, Belagavi, Karnataka
Belgaum
KARNATAKA
590019
India |
| Phone |
9793888829 |
| Fax |
|
| Email |
DRCHATE@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR SAUMYA MISHRA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JNMC MEDICAL COLLEGE,KLE |
| Address |
DEPARTMENT OF PSYCHIATRY,OPD 15,
JNMC KLE University, Belagavi, Karnataka
DEPARTMENT OF PSYCHIATRY,OPD 15,
JNMC KLE University, Belagavi, Karnataka
Belgaum
KARNATAKA
590019
India |
| Phone |
9793888829 |
| Fax |
|
| Email |
MISHRA8SAUMYAA@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi,karnataka,590010,india |
|
|
Primary Sponsor
|
| Name |
Dr Saumya Mishra |
| Address |
Department of Psychiatry,Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi 590010, Karnataka, India |
| 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 |
| Dr Saumya Mishra |
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre |
Department of Psychiatry ,Psychiatry
ward, Sharavati floor,Nehru Nagar, Belagavi,KARNATAKA
Belgaum
KARNATAKA |
9793888829
mishra8saumyaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| jnmc institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
oral ketamine |
ketamine given at 2mg/kg mixed in 100ml of water over a period of 30 minutes Given orally on day 1,3,5,7,9 (total 5 doses given on alternate days) |
| Comparator Agent |
the placebo used is tulsi drops |
2 drops of tulsi mixed in 100ml water will be given in water given orally on day 1,3,5,7,9 (total 5 doses given on alternate days)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient aged above 18 yrs of age
Patients who have given written informed consent
Patient with diagnosis of
1. SINGLE EPISODE DEPRESSIVE DISORDER, severe, without psychotic disorder
2. Recurrent Depressive Disorder, current episode severe without psychotic disorder |
|
| ExclusionCriteria |
| Details |
Bipolar depression
Severe depression with psychotic symptoms
Pregnant and lactating women
Substance abuse (excluding nicotine dependence)
Have received ECT in past 2 months
Did not give consent for the same |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the rapid anti-depressive effect of oral ketamine as an adjuvant antidepressant in
severe depression |
1 yr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the rapid anti suicidal effect of oral ketamine when given as an adjuvant |
1 yr |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
11/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/03/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ketamine use in depression is becoming increasingly popular in psychiatric practice. The FDA has approved Esketamine nasal spray. Few studies have shown the effectiveness of oral ketamine when used in depression. This study intends to find out the efficacy of oral ketamine
when used as adjuvant treatment in severe depression |