| CTRI Number |
CTRI/2025/04/085835 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of IV ketamine in suicidal risk reduction in patients with suicidality |
|
Scientific Title of Study
|
Role of IV ketamine in suicidal risk reduction in patients with suicidality attending psychiatry department in a tertiary care hospital, a placebo based, double blinded, 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 |
Rajashree Mohanta |
| Designation |
Post graduation student |
| Affiliation |
SCB Medical college and Hospital |
| Address |
room no 503
department of psychiatry
Mental Health Institute
SCB Medical college and Hospital
Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
9437280600 |
| Fax |
0671-2416913 |
| Email |
drrajashree91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarada Prasanna Swain |
| Designation |
proffessor and HOD |
| Affiliation |
SCB Medical college and Hospital |
| Address |
Department of psychiatry
Mental Health Institute
SCB Medical college and Hospital
Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
9861014757 |
| Fax |
0671-2416913 |
| Email |
drspswain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajashree Mohanta |
| Designation |
Post graduation student |
| Affiliation |
SCB Medical college and Hospital |
| Address |
room no 503,department of psychiatry
Mental Health Institute
SCB Medical college and Hospital
Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
9437280600 |
| Fax |
0671-2416913 |
| Email |
drrajashree91@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of psychiatry, SCB Medical College and Hospital Cuttack |
|
|
Primary Sponsor
|
| Name |
Rajashree Mohanta |
| Address |
Mental Health Institute
SCB Medical College and Hospital
Cuttack, Odisha |
| 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 Rajashree Mohanta |
SCB Medical College and Hospital |
room no 503,
Department of Psychiatry
Mental health institute
SCB Medical College
cuttack
Cuttack
ORISSA |
9437280600
drrajashree91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee SCB Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IV Ketamin |
IV Ketamin(0.5mg/kg) in 100ml NS infused over 40minutes . 3 infusions given at 2 days interval. total 3 doses of ketamine are going to give. |
| Comparator Agent |
standard treatment for suicide |
in normal standard treatment lithium,SSRI are tried. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
having suicidal ideation measured in BSS Scale |
|
| ExclusionCriteria |
| Details |
cardiovascular disease
intracranial hypertension
head injury
pregnancy
breast feeding
allergy to ketamin
delrium
substance use disorder except nicotine
major psychotic disorder |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| remission of suicidal ideation measured in BSS scale |
baseline
1 week
2 week
4 week
6 months
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
18/05/2025 |
| 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 Yet Recruiting |
| 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
|
in this trial we are going to verify the effectiveness of the iv ketamine in patients with suicidal ideation in indian population. this is a singe blinded trial. every adverse effect was monitered by the investigator. |