| CTRI Number |
CTRI/2021/10/037627 [Registered on: 27/10/2021] Trial Registered Prospectively |
| Last Modified On: |
23/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study the efficacy and safety of Ketamine on patient with Severe depression. |
|
Scientific Title of Study
|
Efficacy and safety of ADD-ON intravenous Ketamine in DSM-V diagnosed severe depressive disorder;a double blind controlled trial. |
| Trial Acronym |
DEPKET |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anand Prakash |
| Designation |
Post Graduate Resident |
| Affiliation |
KIMS and PBMH,Bhubaneshwar |
| Address |
Department of Psychiatry
KIMS and PBMH
Bhubaneshwar
Khordha
ORISSA
751024
India |
| Phone |
7667683640 |
| Fax |
|
| Email |
dr.anandprakash24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudipta kumar das |
| Designation |
Associate Professor |
| Affiliation |
KIMS and PBMH,Bhubaneshwar |
| Address |
Department of Psychiatry
KIMS and PBMH
Bhubaneshwar
Khordha
ORISSA
751024
India |
| Phone |
9439728347 |
| Fax |
|
| Email |
linksudipta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Prakash |
| Designation |
Post Graduate Resident |
| Affiliation |
KIMS and PBMH,Bhubaneshwar |
| Address |
Department of Psychiatry
KIMS and PBMH
Bhubaneshwar
Khordha
ORISSA
751024
India |
| Phone |
7667683640 |
| Fax |
|
| Email |
dr.anandprakash24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical sciences,bhubaneswar |
|
|
Primary Sponsor
|
| Name |
KIMS |
| Address |
Kalinga Institute of Medical sciences,bhubaneswar |
| Type of Sponsor |
Private 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 Anand Prakash |
Kalinga institute of medical sciences |
Room no 3, Department of Psychiatry,OPD Division
Khordha
ORISSA |
7667683640
dr.anandprakash24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS Ethics Committee |
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, (3) ICD-10 Condition: F323||Major depressive disorder, singleepisode, severe with psychotic features, (4) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, (5) ICD-10 Condition: F333||Major depressive disorder, recurrent, severe with psychotic symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ketamine
|
1.Dose-0.5mg/kg diluted in 50ml normal saline over 40mins
2.Frequency-In every 72hours in two weeks
3.Route of Administration- Interavenous
4.Duration of therapy- 2 weeks |
| Comparator Agent |
Normal saline |
1.Dose-50ml normal saline over 40mins
2.Frequency-In every 72hours in two weeks
3.Route of Administration- Interavenous
4.Duration of therapy- 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with severe depression according to the DSM-5 guidelines and ham-d score suggesting Depression.
Patients who give their consent
|
|
| ExclusionCriteria |
| Details |
1.Patients with present diagnosis or antecedents of clinically relevant cardiovascular disorder such as stroke, heart attack,etc
2.Patients with present or past diagnosis of glaucoma, intracranial hypertension
3.Patients with current diagnosis of schizophrenia and related disorder
4.Significant ECG abnormalities
5.History of neurological disease or prior head trauma with evidence of cognitive impairment
6.Known hypersensitivity to ketamine
7.Patients who donot give their informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome of treatment will be measured in terms of reduction of the HAM-D score by more than 50%
|
by at the end of two weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in the score of suicidal risk
Improvement in the global functioning
Persistance of response to as shown by the reduction of HAM-D score for 4 weeks following the discontinuation of ketamine
|
Reduction of HAM-D score for 4 weeks following the discontinuation of ketamine |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
01/11/2021 |
| 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 Applicable |
| 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
|
This is Randomised controlled trial studing safety and efficacy of add on Ketamine in patient of severe Depression. |