| CTRI Number |
CTRI/2024/09/073722 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the anti-depressant effects of Shock therapy (ECT) using Ketamine(New drug) and Thiopentone(Routine Drug) in Severely depressed patients. |
|
Scientific Title of Study
|
Comparison of the rapid anti-depressant effects of Ketamine vs Thiopentone assisted Modified Electro Convulsive Therapy in patients with Severe Depression-A hospital based Randomised Control 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 |
Dr Jaya Rama Rao Ponnamanda |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical college |
| Address |
Department of Psychiatry,Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9392589961 |
| Fax |
|
| Email |
jayram7337@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SS Chate |
| Designation |
Professor and Head, Department of Psychiatry,JNMC |
| Affiliation |
Jawaharlal Nehru Medical college |
| Address |
Department of Psychiatry,Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9880733499 |
| Fax |
|
| Email |
drchate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaya Rama Rao Ponnamanda |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical college |
| Address |
Department of Psychiatry,Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9392589961 |
| Fax |
|
| Email |
jayram7337@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi Karnataka,590010, India |
|
|
Primary Sponsor
|
| Name |
Dr Jaya Rama Rao Ponnamanda |
| Address |
Department of Psychiatry,Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi 590010, Karnataka, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Jaya Rama Rao Ponnamanda |
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre |
Department of Psychiatry Psychiatry ward, Sharavati floor, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA |
9392589961
jayram7337@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F314||Bipolar disorder, current episodedepressed, severe, without psychotic features, (2) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, (3) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, (4) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketamine assisted Modified Electroconvulsive Therapy. |
Electroconvulsive therapy is administered using Ultra Brief pulse stimulation with Intravenous Ketamine as the Anaesthetic agent at a dose of 2-3mg/kg three times a week for 2 weeks. |
| Comparator Agent |
Thiopentone assisted Modified Electroconvulsive Therapy. |
Electroconvulsive therapy is administered using Ultra Brief pulse stimulation with Intravenous Thiopentone as the Anaesthetic agent at a dose of 3-5mg/kg three times a week for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Single Episode Depressive disorder, severe, without psychotic symptoms.
- Recurrent depressive disorder, current episode severe, without psychotic symptoms.
- Bipolar Type I disorder, current episode depressive,severe without psychotic symptoms.
- Bipolar Type II disorder, current episode depressive, severe without psychotic symptoms. |
|
| ExclusionCriteria |
| Details |
- Severe depression with presence of psychotic symptoms
-Primary psychotic disorder
- Mixed episode
- Pregnant and Lactating females
- Severe medical conditions such as Renal failure, Hypertension, IHD |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the rapid anti-depressant effects of Ketamine assisted vs thiopentone assisted modified ECT |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the cognitive effects in patients who have reveived Modified ECT under Ketamine and Modified ECT under Thiopentone |
1 year |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 |
|
Date of First Enrollment (India)
|
20/09/2024 |
| 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="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
|
This study aims to compare the rapid anti depressant effects and Cognitive effects of Ketamine Vs Thiopentone assisted modified Electro Convulsive therapy(ECT) in patients with Severe Depression. Thiopentone is the routinely used drug for induction in Modified ECT. Ketamine is a newer drug which is widely known for it rapid antidepressant properties. This study will use Ketamine as an induction agent in one arm and compare the antidepressant effects and effect in cognitive decline compared to Thiopentone which will be used in the other arm. |