| 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
|
|
|
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
|
|
|
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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