| CTRI Number |
CTRI/2020/08/027340 [Registered on: 24/08/2020] Trial Registered Prospectively |
| Last Modified On: |
19/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A comparative study on the effectiveness of Electroconvulsive therapy and ketamine in person suffering from depressive disorder not responding to medications |
|
Scientific Title of Study
|
a comparative study on the effectiveness of electroconvulsive therapy and ketamine in person suffering from treatment resistant depressive disorder |
| 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 |
| Address |
Ahana Hospitals
No 11 Subburam Street, Gandhi Nagar,
Madurai-625020,
Tamilnadu,
India
Madurai
TAMIL NADU
625020
India |
| Phone |
9443772233 |
| Fax |
|
| Email |
vikhram@ahanahospitals.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVikhram Ramasubramanian |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Ahana hospitals |
| Address |
Ahana Hospitals
No 11 Subburam Street, Gandhi Nagar,
Madurai-625020,
Tamilnadu,
India
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 |
| Address |
Ahana Hospitals
No 11 Subburam Street, Gandhi Nagar,
Madurai-625020,
Tamilnadu,
India
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 |
No.11.Subburam Street, Gandhi Nagar, Madurai-625020, Tamilnadu, India |
| 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 |
| drvikhram ramasubramanian |
Ahana hospitals , |
ahana hospitals
Department of psychiatry
Research Division. 2nd floor
No.11.Subburam Street, Gandhi Nagar, Madurai-625020, Tamilnadu, India
Madurai
TAMIL NADU |
9443772233
vikhram@ahanahospitals.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Radianz Healthcare and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, treatment resistant depression, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Electroconvulsive therapy(ECT) |
ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.Treatments will be given 3 times a week up to a total of 6 treatments over 2-3 weeks |
| Comparator Agent |
Ketamine infusion |
Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.Treatments will be given 3-4 times a week up to a total of 6 treatment over 2-3 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age range 18-60 years
2.Male and Female
3.Written informed consent.
4.Presence of Major Depressive Disorder as per DSM V guidelines
5.Refractory to at least two anti-depressant medications |
|
| ExclusionCriteria |
| Details |
1. Co-morbid psychiatric diagnoses such
as psychosis, bipolar disorder, substance dependence (including nicotine dependence)
2. Mental retardation, neurological disorders and severe medical illness
3. pregnancy or breast feeding
4.Diagnosis of major depressive disorder with psychotic features during the current depressive episode
5.allergy to ketamine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 2-3 weeks ]
Response is defined as at least a 50% improvement in Baseline QIDS-SR-16 score at End of Treatment Visit. The End of Treatment Visit will occur 3-5 weeks after the Baseline Visit.
|
baseline and 2-3 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
clinician reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks ]
Number of patients with an improvement in their Baseline MADRS score at the End of Treatment Visit. The End of Treatment Visit will occur 2-3 weeks after the Baseline Visit.
|
baseline and 2-3 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2020 |
| Date of Study Completion (India) |
31/05/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
depression is known to mankind since years.The world health organization has listed depression as fourth most important health problems worldwide. depression has been projected to be the second largest killer after heart disease by the year 2020 patients with major depression respond to antidepressant treatment, but 10-30 percent of them do not improve or show a partial response coupled with functional impairment, poor quality of life,suicide ideation and attempts,self-injurious behavior and a high relapse rate. treatment resistant depression, a complex clinical problem caused by multiple risk factors, is targeted by integrated therapeutic strategies, which include optimization of medications,a combination of antidepressants,switching of antidepressants amd augmentation with non-antidepressants,psychosocial and cultural therapies,somatic therapies including electroconvulsive therapy,repetitive transcranial magnetic stimulation,magnetic seizure therapy,deep brain stimulation,transcranial direct current stimulation. this study aims at comparing the efficacy of ECT and ketamine infusion in treatment resistant depression.although the efficacy of ECT and ketamine infusion has been well established however a comparative study has never been done |