| CTRI Number |
CTRI/2025/03/083323 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Transcranial Direct Current Stimulation (tDCS) as an Adjuvant Therapy in Patients with Late-Life Depression (LLD): A Single-Blind, Randomized, Sham-Controlled Trial |
|
Scientific Title of Study
|
Transcranial Direct Current Stimulation (tDCS) as an Adjuvant Therapy in Patients with Late-Life Depression (LLD): A Single-Blind, Randomized, Sham-Controlled 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 |
Jahanvi Zandawala |
| Designation |
Junior Resident |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of Psychiatry, Jawaharlal Nehru Medical College, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9429927525 |
| Fax |
|
| Email |
medicojan1997@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, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9880733499 |
| Fax |
|
| Email |
sschate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jahanvi Zandawala |
| Designation |
Junior rResident |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of Psychiatry, Jawaharlal Nehru Medical College, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9880733499 |
| Fax |
|
| Email |
medicojan1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs DR PRABHAKAR KORE HOSPITAL ADN MEDICAL RESEARCH CENTRE , NEHRU NAGAR, BELGAVI, KARNAKTAKA, 590010 |
|
|
Primary Sponsor
|
| Name |
Jahanvi Zandawala |
| Address |
Department of Psychiatry, Jawaharlal Nehru Medical College, Belagavi |
| 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 Jahanvi Zandawala |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi, Karnataka, 590010 |
Department of Psychiatry, Psychiatry Ward and OPD, Jawaharlal Nehru Medical College, Belagavi
Belgaum
KARNATAKA |
9429927525
medicojan1997@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: F328||Other depressive episodes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transcranial Direct Current Stimulation |
tDCS will be applied for 30 minutes, twice a day, for 5 days for patients diagnosed with late-life depression |
| Comparator Agent |
Transcranial Direct Current Stimulation – Sham-Controlled |
Sham tDCS will also be applied for 30 minutes, twice a day, for 5 days in patients diagnosed with late-life depression |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.60 years of age or older and diagnosed with Late Life Depression.
2. All patients who give valid consent
|
|
| ExclusionCriteria |
| Details |
1 Patients who are less than 60 years of age.
2. Other psychiatric comorbidities except mild anxiety.
3. Substance use disorder except tobacco.
4. High risk for suicide.
5. Serious brain diseases or unstable medical conditions that impairs decision taking
capacity.
6. Any other significant communication barrier.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of efficacy of tDCS as an adjuvant to anti depressants in patients
diagnosed with late life depression in comparison with sham controlled tDCS.
|
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To assess for rapid antidepressant effect of tDCS as an adjuvant to antidepressants in patients diagnosed with Late Life Depression.
2. To assess for the effect of tDCS on cognitive functions in patients diagnosed with Late Life Depression |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
15/04/2025 |
| 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
|
Late-life depression (LLD) affects individuals aged 60 and older, often complicating treatment due to comorbid conditions and lower efficacy of standard treatments like antidepressants and psychotherapy, tDCS is a non-invasive technique that uses mild electric currents through scalp electrodes to modulate brain activity, enhance synaptic release, and improve neural plasticity. It addresses hypoactivity and low serotonin levels in the dorsolateral prefrontal cortex (DLPFC), a key area affected in depression. Unlike traditional antidepressants, which take time to show effects, and electroconvulsive therapy (ECT), which is invasive, tDCS offers a quicker, non-invasive alternative.This study aims to assess the effects of transcranial direct current stimulation (tDCS) as an adjuvant to antidepressants in patients with late-life depression, as well as its impact on cognitive functions, by comparing it to a sham tDCS group.
|