| CTRI Number |
CTRI/2022/04/042071 [Registered on: 22/04/2022] Trial Registered Prospectively |
| Last Modified On: |
19/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Ketamine as an adjuvant for the treatment of first episode depression |
|
Scientific Title of Study
|
Clinical utility of adjuvant ketamine in first episode depression- a double blind, placebo controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikhram Ramasubramanian |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Ahana hospitals, LLP |
| Address |
Ahana hospitals, Department of psychiatry Research Division. 2nd floor, No.11.Subburam Street, Gandhi Nagar, Madurai.
Madurai
TAMIL NADU
625020
India |
| Phone |
9443772233 |
| Fax |
|
| Email |
vikhram@ahanahospitals.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vikhram Ramasubramanian |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Ahana hospitals, LLP |
| Address |
Ahana hospitals, Department of psychiatry Research Division. 2nd floor, No.11.Subburam Street, Gandhi Nagar, Madurai.
Madurai
TAMIL NADU
625020
India |
| Phone |
9443772233 |
| Fax |
|
| Email |
vikhram@ahanahospitals.in |
|
Details of Contact Person
Public Query
|
| Name |
Vikhram Ramasubramanian |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Ahana hospitals, LLP |
| Address |
Ahana hospitals, Department of psychiatry Research Division. 2nd floor, No.11.Subburam Street, Gandhi Nagar, Madurai.
Madurai
TAMIL NADU
625020
India |
| Phone |
9443772233 |
| Fax |
|
| Email |
vikhram@ahanahospitals.in |
|
|
Source of Monetary or Material Support
|
| Ahana Hospitals LLP, No.11.Subburam Street, Gandhi Nagar, Madurai-625020, Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Ahana Hospitals LLP |
| Address |
Ahana Hospitals LLP
11,subburam street, Madurai |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| vikhram ramasubramanian |
Ahana hospitals LLP |
Department of Psychiatry, Research division,
No 11, subburaman street,
Madurai
Madurai
TAMIL NADU |
9443772233
vikhram@ahanahospitals.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Radianz Healthcare and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, (2) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketamine Adjuvant |
This arm will receive three infusions of ketamine at 0.5mg/kg dosage on alternate days, in addition to SSRI (escitalopram 10 mg) |
| Comparator Agent |
Midazolam (active control) |
This arm will receive three infusion of midazolam at 0.045mg/kg dosage on alternate days, in addition to SSRI (escitalopram 10 mg) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants willing to sign a written informed consent document;
Participants must fulfill ICD criteria for Depressive episode , with the severity being moderate to severe
Participants must be medically and neurologically healthy.
|
|
| ExclusionCriteria |
| Details |
Those who have neurological disorders, severe medical illness, mental retardation and co-morbid psychiatric diagnoses
Women who are pregnancy or breastfeeding
Those who are allergic to ketamine |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hamilton Depression rating scale (HAM-D) to assess severity of depression |
baseline, day 2, day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Beck Scale for Suicidal Ideation (BSSI) to assess the level of suicidal ideation |
baseline, day 2 and day 14 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/04/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Ketamine has been widely explored for its therapeutic effects on various psychiatric illnesses. Many studies have brought to light its role in treatment-resistant depression. Though ketamine is found to have rapid antidepressant activity, no study has explored its use as an add-on in the first episode depression. A quick relief from one of the most disabling disorders enables an individual to get back to his/her daily activities as early as possible and also significantly reduces the distress associated with it. |