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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  
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 
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  
Status 
Not Applicable 
 
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.

 
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