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CTRI Number  CTRI/2024/01/061652 [Registered on: 19/01/2024] Trial Registered Prospectively
Last Modified On: 16/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To Compare Side Effects Of ECT Vs Ketamine 
Scientific Title of Study   A Study Of Neurocognitive Side Effects Of Ketamine Versus Electroconvulsive Therapy In Patients With Major Depressive Disorder- A Comparative Study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Heli Yogesh Shah 
Designation  Junior Resident  
Affiliation  Lokmanya Tilak Municipal Medical College And General Hospital 
Address  Department Of Psychiatry, OPD 21,2nd Floor, New Opd Building, Near gate no 7, Sion hospital, Sion

Mumbai (Suburban)
MAHARASHTRA
400022
India 
Phone  9833788036  
Fax    
Email  shahheli98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nilesh Shah 
Designation  Professor And Head Of Department 
Affiliation  Lokmanya Tilak Municipal Medical College And General Hospital 
Address  Department Of Psychiatry, OPD 21, 2nd Floor, New OPD Building, Sion Hospital, Sion

Mumbai (Suburban)
MAHARASHTRA
400022
India 
Phone  9821788658  
Fax    
Email  drnilshah@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Heli Yogesh Shah 
Designation  Junior Resident  
Affiliation  Lokmanya Tilak Municipal Medical College And General Hospital 
Address  Department Of Psychiatry, OPD 21, 2nd Floor, New Opd Building, Sion Hospital, Sion

Mumbai (Suburban)
MAHARASHTRA
400022
India 
Phone  9833788036  
Fax    
Email  shahheli98@gmail.com  
 
Source of Monetary or Material Support  
Department Of Psychiatry OPD 21,2nd Floor, New Opd Building, Sion Hospital, Sion 
 
Primary Sponsor  
Name  Department of Psychiatry Sion hospital 
Address  OPD 21, 2nd Floor, New Opd Building, Sion Hospital, Sion 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Heli Shah  Lokmanya Tilak Municipal Medical College And General Hospital  OPD21, 2nd Floor, New Opd Building, Sion Hospital, Sion
Mumbai (Suburban)
MAHARASHTRA 
9833788036

shahheli98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Human Research Lokmanya Tilak Municipal Medical College & General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Electroconvulsive Therapy  Total 12 ECT Sessions 6 ECTs - Twice A Week Rest ECTs - Once A Week With Prescribed Medications As Advised 
Comparator Agent  Oral Ketamine  125 - 175 Mg Over 12-15 Mins Duration Total 12 Sessions 6 Sessions - Twice A Week Rest Sessions - Once A Week With Prescribed Medications As Advised 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patients above 18 years of age.
Patients diagnosed with MDD and not better with medications.
Patients requiring ECT. 
 
ExclusionCriteria 
Details  Patient not willing to give consent.
Pregnant and Lactating woman.
Patients having contraindications for ECT and Ketamine.
Patients with comorbid substance use except Nicotine.
Patients who have received either ECT or ketamine during the past 6 months.
Patients with a history of non-responsiveness to ECT or ketamine.
Patients with any condition that is known to be associated with cognitive
impairment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
ECT Has More Neurocognitive Side Effects Than Ketamine   Baseline, 1 Week Post Treatment Endpoint, 1 Month Post Treatment Endpoint 
 
Secondary Outcome  
Outcome  TimePoints 
To Check How Much Less Neurocognitive Side Effects Does Ketamine Have As Compared To ECT  Baseline, 1 Week Post Treatment Endpoint, 1 Month Post Treatment Endpoint  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   24/01/2024 
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  

ECT in depression –

Currently, there are two main treatments to fight depression, antidepressants and psychotherapy, while a third approach, electroconvulsive therapy (ECT), is regarded as a second- or third-line therapy that is usually resorted to in cases where medication and psychotherapy have failed (Kellner et al., 2016b; Karayagmurlu et al., 2019). However, most patients who were resistant to antidepressant or psychotherapy showed improvement after ECT was introduced. In other words, ECT may have a greater effect than the two routinely used methods in fighting depression

Cognitive decline was noted in some depressed patients who received ECT (Brus et al., 2017), and recovery from this declination was suggested to take half a year (Nuninga et al., 2018). However, whether ECT contributed more memory loss than pharmaceutical treatment is still in dispute, but the majority support the view of no additional cognitive damage ascribable to ECT than antidepressants (Husain et al., 2004; Kellner et al., 2016a, b; Bjoerke-Bertheussen et al., 2018). Nonetheless, some studies found no dementia in individuals who underwent ECT (Osler et al., 2018), and in geriatric depressed patients, ECT even improved cognitive function (Socci et al., 2018).

With respect to other common side effects that occurred during ECT treatment, headache and nausea/vomiting are believed to be the most common complaints (Kellner et al., 2006; Karayagmurlu et al., 2019). Thankfully, in the view of severity and prevalence, the ECT recipients reported less headache and nausea/vomiting in recent studies (Husain et al., 2004; McCall et al., 2018; Socci et al., 2018).

Ketamine in depression –

Recent studies are accepting the role of glutamate in depression, in particular NMDA receptors along with serotonin receptors. While conventional pharmacotherapy usually takes several weeks (usually 4-12 weeks) to improve symptoms, Ketamine is an N-methyl-D aspartate receptor antagonist having rapid action on depressive symptoms.

Regardless of the ketamine form, patients commonly experience dissociative adverse effects, such as psychosis-like conditions. In addition to the dissociative side effects of ketamine therapy, there are also physiological effects. For example, roughly 40% of people given a single dose of IV ketamine have increased heart rate and blood pressure for a limited time after treatment. Patients have also experienced symptoms including anxiety, blurred vision, dizziness, headache, nausea, or vomiting with the use of ketamine.

Eriksson notes that the peak concentration of oral ketamine is much lower than that of IV ketamine. Since ketamine’s action on NMDA receptors causes dissociative side effects, clinicians believe a lower peak dosage has improved tolerability.


 
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