| CTRI Number |
CTRI/2024/10/075361 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Intravenous versus oral Ketamine treatment for suicidality in patients with severe depression |
|
Scientific Title of Study
|
Effect of ketamine treatment on suicidality among severely depressed patients at high risk of suicide |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swarndeep Singh |
| Designation |
Assistant Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Psychiatry
VMMC and Safdarjung Hospital
Delhi
South West
DELHI
110029
India |
| Phone |
9650757749 |
| Fax |
|
| Email |
sevisingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swarndeep Singh |
| Designation |
Assistant Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Psychiatry
VMMC and Safdarjung Hospital
Delhi
DELHI
110029
India |
| Phone |
9650757749 |
| Fax |
|
| Email |
sevisingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swarndeep Singh |
| Designation |
Assistant Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Psychiatry
VMMC and Safdarjung Hospital
Delhi
DELHI
110029
India |
| Phone |
9650757749 |
| Fax |
|
| Email |
sevisingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, Delhi-110029. |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital,
Delhi, India-110029 |
| 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 Swarndeep Singh |
VMMC and SJH |
Room Number-331, Department of Psychiatry, VMMC and Safdarjung Hospital,
Delhi-110029
South West
DELHI |
9650757749
sevisingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of VMMC and SJH |
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: F322||Major depressive disorder, singleepisode, severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IV Ketamine infusion |
Slow IV ketamine infusion dose of 0.5 to 1.0 mg/kg body weight over 40 minutes duration depending upon patients’ tolerability and response. A total of six sessions of alternate-day ketamine treatment over two weeks will be given under close medical supervision and vitals monitoring. |
| Intervention |
Oral Ketamine |
Oral ketamine at a dose of 150 to 300 mg per session depending upon patients’ tolerability and response. A total of six sessions of alternate-day ketamine treatment over two weeks will be given under close medical supervision and vitals monitoring. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Month(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 to 45 years
2. Clinically significant depressive episode as per the DSM 5 criteria (HDRS-17 total score of more than 16)
3. Moderate to High Suicidal Risk (Baseline HDRS-17 Suicide Item score of more than 2)
4. No psychotic symptoms present in the current depressive episode
5. No comorbid psychiatric disorder
6. No substance use disorder except nicotine and caffeine during past one year
7. No known or suspected contraindication to ketamine treatment |
|
| ExclusionCriteria |
| Details |
1. Uncontrolled medical condition (hypertension, cardiovascular disease, cerebrovascular disease, chronic liver disease, active infections)
2. Pregnant and lactating females
3. History of receiving any neuromodulation therapy (e.g., ECT, rTMS, tDCS) within the last three months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the change in suicidal ideation severity with oral and intravenous ketamine treatment in patients with depression |
Assessment of study outcomes (HDRS-17, MSSI, HAM-A, VAS for pain, KSET) will be done at baseline, 1, 2, 4, and 6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| a)To assess and compare the change in severity of depressive symptoms, anxiety symptoms, and pain symptom with oral and intravenous ketamine treatment in patients with depression |
Baseline, 1, 2, 4, and 6 weeks. |
| b)To assess and compare the frequency of adverse effects with oral and intravenous ketamine treatment in patients with depression |
Baseline, 1, 2, 4, and 6 weeks. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/10/2024 |
| 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
|
Till date, several congeners of ketamine and routes of administration has been tried for treatment of depression with variable success. Esketamine (S-enantiomer of ketamine) nasal spray has also received US Food and Drug Administration (FDA) approval for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression) in the year 2018. While intravenous (IV) administration of ketamine has been widely regarded as the gold-standard treatment route, oral ketamine is preferred by many researchers over IV ketamine due to its better safety profile, enhanced accessibility and scalability. However, a group of researchers have also expressed concerns regarding reduced or loss of efficacy of ketamine via the oral route vis-a-vis the intravenous route. Bulk of this scientific literature (barring few case reports or small case series) is from western countries that might not be generalizable to the Indian population due to differences in the genetic makeup, ethnicity, and prevailing socio-cultural norms shown to influence depression symptom severity and response to treatment. This assumes even more importance, when dosing related decisions and the safety profile of a treatment needs to be determined. Thus, we plan to conduct this study to assess and compare the tolerability and effectiveness of oral and IV ketamine for treatment of suicidal ideation among patients with severe depression. |