| CTRI Number |
CTRI/2025/02/080302 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Ketamine effectiveness in acute suicidality |
|
Scientific Title of Study
|
Ketamine infusion therapy for rapid and sustained response in acute suicidality: A double blind, randomised placebo 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 Vinil Marwel Gundu |
| Designation |
Post Graduate Student |
| Affiliation |
ESI Medical College and Hospital, Sanath Nagar, Hyderabad. |
| Address |
Room no-210, Department of Psychiatry, 2nd floor, OPD building.
Esic medical college and hospital, sanathnagar
Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9398027898 |
| Fax |
|
| Email |
gvinilmarwel1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Naveen Kumar Dhagudu |
| Designation |
Professor and HOD |
| Affiliation |
ESI Medical College and Hospital, Sanath Nagar, Hyderabad. |
| Address |
Room no-210, Department of Psychiatry, 2nd floor, OPD building, ESIC Medical College and Hospital, Sanathnagar, Hyderabad.
Hyderabad
TELANGANA
500038
India |
| Phone |
9398027898 |
| Fax |
|
| Email |
naveendhagudu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinil Marwel Gundu |
| Designation |
Post Graduate Student |
| Affiliation |
ESI Medical College and Hospital, Sanath Nagar, Hyderabad. |
| Address |
Room no-210, Department of Psychiatry, 2nd floor, OPD building.
Esic medical college and hospital, sanathnagar
Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9398027898 |
| Fax |
|
| Email |
gvinilmarwel1@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital, Sanathnagar, Hyderabad, Telangana, India, 500038. |
|
|
Primary Sponsor
|
| Name |
ESIC Medical College and Hospital, Hyderabad |
| Address |
ESI Hospital Sanath Nagar, Essae Digitronics Road, Model Colony, BK Guda, Sanath Nagar, Hyderabad, Telangana 500038, India. |
| 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 Vinil Marwel Gundu |
ESIC Medical College and Hospital, Hyderabad |
Room no-210, Department of Psychiatry, 2nd floor, OPD building.
Esic medical college and hospital, sanathnagar
Hyderabad
Hyderabad
TELANGANA |
9398027898
gvinilmarwel1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ESIC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T424||Poisoning by, adverse effect of and underdosing of benzodiazepines, (2) ICD-10 Condition: T36||Poisoning by, adverse effect of and underdosing of systemic antibiotics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketamine |
0.5mg/kg infusion over 40 min only once |
| Comparator Agent |
saline |
infusion over 40 minutes only once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 18-60 years who attempted suicide and come to ESIC hospital emergency department.
2) Patients who has MADRS Score : < 20
3) Patients who has SSI score : < 15
4) Patients who has BIS-11 score > 65
5) Subjects who are co-operative and willing to give written informed consent for participation in the study.
|
|
| ExclusionCriteria |
| Details |
1) Patients with other active psychiatric disorders diagnosed according to ICD-10.
2)Patients who has MADRS Score : > 20
3) Patients who has SSI score : > 15
4) Patients who has BIS-11 score < 65
5) History of any cardiovascular disease.
6) Any significant neurological disorder or insult.
7) Patients with acute physical illness.
8) Known or suspected pregnancy or lactation.
9) Patients with intra-cranial implants, pacemakers, cochlear implants, implantation of medication pumps.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Objectives : To assess the impact of Ketamine augmented Pharmacotherapy in decreasing Impulsivity. |
baseline, 24 hours, and 1 week,2 weeks, 12 weeks, 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Objectives :
i) To study the prevalence of impulsive suicides among the suicidal attempts
ii) To study Age, gender and education patterns in suicide attempts
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="6"
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
|
An intervental study with research titile"Ketamine infusion therapy for rapid and sustained response in Acute Suicidality: A double blind, randomised placebo controlled trial ", planned with the purpose to evaluate the impact of Ketamine augmented Pharmacotherapy in achieving acute and sustained response of acute suicidal behaviour. Objectives: Primary Objectives : To assess the impact of Ketamine augmented pharmacotherapy in decreasing Impulsivity as in acute and sustained manner . Secondary Objectives : i) To study the prevalence of impulsive suicides among the suicidal attempts ii) To study Age, gender and education patterns in suicide attempts Study universe: Department of Psychiatry, ESIC Medical college and Hospital. Study period: 18 months eligibility criteria:
Inclusion Criteria: 1) Age: 18-60 years who attempted suicide and come to ESIC hospital emergency department. 2) Patients who has MADRS Score : < 20 3) Patients who has SSI score : < 15 4) Patients who has BIS-11 score > 65 5) Subjects who are co-operative and willing to give written informed consent for participation in the study. Exclusion Criteria: 1) Patients with other active psychiatric disorders diagnosed according to ICD-10. 2)Patients who has MADRS Score : > 20 3) Patients who has SSI score : > 15 4) Patients who has BIS-11 score < 65 5) History of any cardiovascular disease. 6) Any significant neurological disorder or insult. 7) Patients with acute physical illness. 8) Known or suspected pregnancy or lactation. 9) Patients with intra-cranial implants, pacemakers, cochlear implants, implantation of medication pumps.
Procedure: a. Participants meeting the inclusion and exclusion criteria will be randomized into one of two groups: ketamine infusion or placebo infusion. b. The ketamine infusion group will receive a bolus dose of 0.5mg/kg ketamine over 40 minutes. c. The placebo group will receive a saline infusion over the same duration and volume as the ketamine infusion. d. Assessments of suicidal ideation, Impulsivity and depression severity will be conducted at baseline, 24 hours, and 2 weeks, 12 weeks, 24 weeks after the infusion using the Barratt Impulsiveness Scale(BIS-11), MADRS-S scale and the Beck Scale for Suicide Ideation (BSS). |