| CTRI Number |
CTRI/2025/07/090531 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| 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
|
Can tDCS Help as an Add On Treatment for Bipolar Depression A Randomized Controlled Trial |
|
Scientific Title of Study
|
THE EFFECTIVENESS AND SAFETY OF TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS) AS AN ADJUVANT TREATMENT FOR PATIENTS WITH BIPOLAR DEPRESSION - A RANDOMIZED SHAM CONTROLLED TRIAL. |
| Trial Acronym |
ETAB BD Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayalakshmi M K |
| Designation |
post graduate student department of psychiatry |
| Affiliation |
Dharwad institute of mental health and neurosciences |
| Address |
Department of psychiatry, Dharwad Institute Of Mental Health And Neurosciences (DIMAHNS), Room No.2, DIMHANS Campus, Dharwad
Dharwad KARNATAKA 580008 India |
| Phone |
9481787932 |
| Fax |
|
| Email |
jayalakshmimk3@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manjunath R Bajantri |
| Designation |
Associate Professor Department of Psychiatry |
| Affiliation |
Dharwad institute of mental health and neurosciences |
| Address |
Department of psychiatry, Dharwad Institute Of Mental Health And Neurosciences (DIMAHNS), Room No.2, DIMHANS Campus, Dharwad
Dharwad KARNATAKA 580008 India |
| Phone |
98807721102 |
| Fax |
|
| Email |
rbmanjunath@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Manjunath R Bajantri |
| Designation |
Associate Professor Department of Psychiatry |
| Affiliation |
Dharwad institute of mental health and neurosciences |
| Address |
Department of psychiatry, Dharwad Institute Of Mental Health And Neurosciences (DIMAHNS), Room No.2, DIMHANS Campus, Dharwad
Dharwad KARNATAKA 580008 India |
| Phone |
98807721102 |
| Fax |
|
| Email |
rbmanjunath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No.2,Department of psychiatry, Dharwad Institute Of Mental Health And Neurosciences (DIMAHNS), DIMHANS Campus, Dharwad, Karnataka, India 580008 |
|
|
Primary Sponsor
|
| Name |
Dharwad Institute Of Mental Health And Neurosciences |
| Address |
Room No.2,Department of psychiatry, Dharwad Institute Of Mental Health And Neurosciences (DIMAHNS), DIMHANS Campus, Dharwad, Karnataka, India 580008 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Jayalakshmi M K |
Dharwad Institute of Mental Health and Neurosciences |
Room No.2,Department of psychiatry, Dharwad Institute Of Mental Health And Neurosciences (DIMAHNS), DIMHANS Campus, Dharwad, Karnataka, India 580008 Dharwad KARNATAKA |
9481787932
jayalakshmimk3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee DIMHANS Dharwad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F313||Bipolar disorder, current episodedepressed, mild or moderate severity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transcranial direct current stimulation |
protocol involved 20 minutes of active tDCS with anode at left DLPFC F3 and cathode at right supraorbital Fp1 in active group minimum of 7 sessions is required stimulation is set at 2 mA for 20 minutes during which the current is increased linearly over 15 sec from 0.5 to 2 mA and also at the end of each session the current is decreased gradually over a 15sec ramp down period
total duration of the procedure is 20 minutes |
| Comparator Agent |
Transcranial direct current stimulation SHAM |
In the sham group participants receive 7 sessions During each session stimulation is applied at 2 mA for the initial 1 minute the current is ramped up from 0.5 mA to 2 mA over the first 15 seconds held briefly and then ramped down over the final 15 seconds For the remaining 18 minutes no current is delivered
total duration of the procedure is 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Adult aged 18 to 60 years
2 Any gender
3 Diagnosis of bipolar disorder depressive episodes as per ICD 1 1 criteria
4 Currently experiencing a moderate to severe depressive episode as per BDI score more than 19
5 Able to provide informed written consent
|
|
| ExclusionCriteria |
| Details |
1 History of seizures
2 Presence of metal implants pacemakers or other electronic medical devices
3 Pregnancy or breast feeding mother
4 Substance use disorder except nicotine use
5 Use of other neuro modulator treatment in the present admission
6 With active suicide ideations
7 Uncontrolled co morbidities or any neurological disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate effectiveness and safety of tDCS in bipolar depression improvement as measured by
BDI scores
|
baseline, 2 weeks, one month post intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor and document any adverse effects, including mood switching using YMRS and tDCS side effects checklist (example hypomania or mania)
Cognitive functioning and evaluation
To measure overall improvement in Quality of life
|
baseline, 2 weeks, one month post intervention |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
01/08/2025 |
| 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 Applicable |
| 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
|
This study aims to evaluate the effectiveness and safety of Transcranial Direct Current Stimulation that is tDCS as an adjunctive treatment for patients with bipolar depression. Bipolar depression, the more disabling phase of bipolar disorder, is associated with a high risk of suicide, longer illness duration, and poorer response to traditional treatments. While pharmacological and psychotherapeutic approaches remain the standard, many patients do not achieve complete remission, highlighting the need for alternative strategies. tDCS is a non-invasive, affordable, and safe neuromodulation technique that uses low-intensity electrical currents to stimulate targeted brain regions, particularly the left dorsolateral prefrontal cortex, which is often underactive in depression. This randomized, single-blind, sham-controlled trial will be conducted at DIMHANS, Dharwad, with adult patients aged 18 to 60 who meet ICD 11 criteria for bipolar depression and have a BDI score above 19. Participants will receive either active tDCS or sham stimulation over a minimum of 7 sessions. Depression severity will be assessed using the Beck Depression Inventory, and secondary outcomes will include monitoring for side effects, mood switching checked with YMRS, cognitive function by MoCA, and quality of life WHOQOL BREF. The study is expected to recruit 88 participants, accounting for dropout, and statistical analysis will be performed using SPSS software. By generating local data, the study aims to fill a gap in Indian research on tDCS and explore its potential as a safe and effective adjuvant therapy in managing bipolar depression. |