| CTRI Number |
CTRI/2018/06/014545 [Registered on: 18/06/2018] Trial Registered Prospectively |
| Last Modified On: |
19/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
to study the effectiveness of ECT and tDCS in depression patients not responding to drugs |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of ECT and tDCS in treatment resistant depression |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVikhram Ramasubramanian |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Ahana Hospitals |
| Address |
No 11 Subburam Street,
Gandhi Nagar,
Madurai-625020,
Tamilnadu,
India
Madurai
TAMIL NADU
625020
India |
| Phone |
9443772233 |
| Fax |
|
| Email |
vikharm@ahanahospitals.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVikhram Ramasubramanian |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Ahana Hospitals |
| Address |
No 11 Subburam Street,
Gandhi Nagar,
Madurai-625020,
Tamilnadu,
India
Madurai
TAMIL NADU
625020
India |
| Phone |
9443772233 |
| Fax |
|
| Email |
vikharm@ahanahospitals.in |
|
Details of Contact Person
Public Query
|
| Name |
DrVikhram Ramasubramanian |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Ahana Hospitals |
| Address |
No 11 Subburam Street,
Gandhi Nagar,
Madurai-625020,
Tamilnadu,
India
Madurai
TAMIL NADU
625020
India |
| Phone |
9443772233 |
| Fax |
|
| Email |
vikharm@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 LLP |
Department of Psychiatry,
Research Division,
No.11.Subburam Street,
Gandhi Nagar,
Madurai-625020
Madurai
TAMIL NADU |
9443772233
vikharm@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, Treatment resistant depression, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Electro Convulsive Therapy |
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 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion |
| Comparator Agent |
Trans-cranial Direct Current Stimulation(tDCS) |
Is a non-invasive neuromodulatory brain stimulation technique that delivers low intensity,direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity. tDCS application as follows-R tDCS procedures will be done as per established guidelines with stringent safety standards. The anodal stimulation site (left DLPFC) will be localized (10-20 system) ;cathode would be placed over the right DLPFC. The stimulation would be done with 2mA 20-minute twice daily sessions separated by atleast 3-hours for 5 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 2 weeks ]
Response is defined as at least a 50% improvement in Baseline BDI score at End of Treatment Visit. The End of Treatment Visit will occur 2 weeks after the Baseline Visit
|
Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 2 weeks ]
Response is defined as at least a 50% improvement in Baseline BDI score at End of Treatment Visit. The End of Treatment Visit will occur 2 weeks after the Baseline Visit
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinician reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 2 weeks ]
Number of patients with an improvement in their Baseline HAM-D score at the End of Treatment Visit. The End of Treatment Visit will occur 2 weeks after the Baseline Visit.
|
Baseline and 2 weeks after the baseline visit |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/06/2018 |
| Date of Study Completion (India) |
31/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Depression is known to mankind since years.The World Health Organization (WHO) has listed depression as fourth most urgent 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% 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, and augmentation with non-antidepressants, psychosocial and cultural therapies, and somatic therapies including electroconvulsive therapy, repetitive transcranial magnetic stimulation, magnetic seizure therapy, deep brain stimulation, transcranial direct current stimulation, and vagus nerve stimulation. This study aims at comparing the efficacy of ECT and tDCS in treatment resistant depression. Although the efficacy of ECT and tDCS in treatment resistant depression has been well established however a comparative study has never been done. |