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CTRI Number  CTRI/2026/02/103109 [Registered on: 05/02/2026] Trial Registered Prospectively
Last Modified On: 04/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Combining High-Definition Transcranial Direct Current Stimulation and Intermittent Theta Burst Stimulation in Treating Major Depressive Disorder: A Randomized Sham-Controlled Study 
Scientific Title of Study   Efficacy of combined high-definition transcranial direct current stimulation with intermittent theta burst stimualtion in treatment of major depressive disorder: a 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  Dr Shobit Garg 
Designation  Professor 
Affiliation  Sri Guru Ram Rai Institute of medical and health sciences 
Address  Room no. 92, South Block, Department of Psychiatry, Sri Guru Ram Rai Institute of medical and health sciences, Patel Nagar, Dehradun, Uttarakhand 248001 India

Dehradun
UTTARANCHAL
248001
India 
Phone  8958534261  
Fax    
Email  shobit.garg@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shobit Garg 
Designation  Professor 
Affiliation  Sri Guru Ram Rai Institute of medical and health sciences 
Address  Room no. 92, South Block, Department of Psychiatry, Sri Guru Ram Rai Institute of medical and health sciences, Patel Nagar, Dehradun, Uttarakhand 248001 India


UTTARANCHAL
248001
India 
Phone  8958534261  
Fax    
Email  shobit.garg@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kirat Kaur 
Designation  Junior Resident 
Affiliation  Sri Guru Ram Rai Institute of medical and health sciences 
Address  room no 304, third floor, shiva apartments, patel nagar, dehradun, 248001, India

Dehradun
UTTARANCHAL
248001
India 
Phone  8427600013  
Fax    
Email  kiratkaur1329@gmail.com  
 
Source of Monetary or Material Support  
Sri Guru Ram Rai Institute of medical and health sciences, Patel Nagar, Dehradun, Uttarakhand, 248001 India 
 
Primary Sponsor  
Name  Sri Guru Ram Rai Institute of medical and health sciences 
Address  SGRRIMHS(Sri Guru Ram Rai Institute of medical and health sciences), Patel Nagar, Dehradun, 248001 
Type of Sponsor  Private 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 
Dr Kirat Kaur  Shri Mahant Indiresh Hospital  Department of Psychiatry, Sri Guru Ram Rai Institute of medical and health sciences, patel nagar, dehradun, uttarakhand, India
Dehradun
UTTARANCHAL 
8427600013

kiratkaur1329@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  high definition transcranial direct current stimulation with intermittent theta burst stimulation in active patients  Patient will be given HDtDCS by placing anode at the left dorsolateral pre frontal cortex (see figure 1). 3cm x3cm sized electrodes will be used. The active HDtDCS group will receive 5 sessions (one per day) in one week. A total of 10 sessions in 2 weeks will be given. 2mA current and for 20 minutes. The HDtDCS session will be applied 30 minutes prior to rTMS session. For the tDCS procedure, the patient would sit on the chair assigned. Then preparation of cap, tDCS machine setup and electrode placement will be done. Anodal stimulation will be done for 20 minutes. 4 returning electrodes will be placed surrounding the side of anodal stimulation. In the sham tDCS group all parameters will be the same except the intensity of the current being 0.2mA. tDCS side effect check list shall be applied every each session. 
Comparator Agent  high definition transcranial direct current stimulation with intermittent theta burst stimulation in sham patients  Patient will be given HDtDCS by placing anode at the left dorsolateral pre frontal cortex (see figure 1). 3cm x3cm sized electrodes will be used. The active HDtDCS group will receive 5 sessions (one per day) in one week. A total of 10 sessions in 2 weeks will be given. 2mA current and for 20 minutes. The HDtDCS session will be applied 30 minutes prior to rTMS session. For the tDCS procedure, the patient would sit on the chair assigned. Then preparation of cap, tDCS machine setup and electrode placement will be done. Anodal stimulation will be done for 20 minutes. 4 returning electrodes will be placed surrounding the side of anodal stimulation. In the sham tDCS group all parameters will be the same except the intensity of the current being 0.2mA. tDCS side effect check list shall be applied every each session. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  1.Patient with a diagnosis of Major Depressive Disorder based on diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition

2.Patients aged between 18 to 59 years

3.Right handed patients

4.Illness severity with HAM D score more than 20 
 
ExclusionCriteria 
Details  1.Any other major mental disorders.
2.Any other Substane use disorder except nicotine and caffeine.
3.Patient is uncooperative for the procedure.
4.Patients with neurological disorders with history of epilepsy, organic brain damage or any neurological procedures
5.Patients with implanted metallic devices
6.Patients receiving ECT in past 6 months.
7.Patients with significant unstable medical conditions like uncontrolled hypertension, complicated diabetes mellitus, organic failures, etc.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
• To compare the quantitative change in depressive symptoms in patients suffering from Major Depressive disorder following high definition transcranial direct current stimulation with intermittent theta burst stimulation, compared to combined sham stimulation.  day 0, day 15, day 30 
 
Secondary Outcome  
Outcome  TimePoints 
•To compare the change of quality of life following high definition transcranial direct current stimulation with intermittent theta burst stimulation, compared to combined sham stimulation in patients suffering from Major Depressive disorder.  day 0, day 15, day 30 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   16/02/2026 
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="6"
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  
Major Depressive Disorder MDD is a debilitating mood disorder characterized by persistent low mood and loss of interest for two weeks or more accompanied by sleep and appetite changes fatigue impaired concentration and suicidal thoughts. It severely impacts social occupational and personal functioning. MDD is more common in women with onset typically in early adulthood. The development of MDD is influenced by a complex interplay of genetic and environmental factors with heritability estimated at around thirty five percent. It is linked to brain abnormalities particularly in the hippocampus and networks involved in emotion regulation and cognitive control.

The National Mental Health Survey conducted during 2015 to 2016 across twelve states with thirty four thousand eight hundred and two adults found a lifetime prevalence of depressive disorders of five point two five percent. Diagnosed MDD frequently goes untreated in India. A 2024 study showed that among middle aged and older adults with depression ninety seven percent remained undiagnosed and seventy seven percent untreated with rural areas being particularly underserved.

Diagnostic criteria include the presence of at least five symptoms out of nine including either depressed mood or anhedonia. These symptoms are depressed mood either subjective or observed anhedonia or loss of interest or pleasure weight or appetite changes insomnia or hypersomnia psychomotor agitation or retardation fatigue feelings of worthlessness or excessive guilt impaired concentration and suicidal ideation. Symptoms must cause significant distress or functional impairment. The condition should not be attributable to substances or medical conditions such as hyperthyroidism. Psychotic disorders and bipolar disorder must be ruled out with no history of mania or hypomania. Specifiers include severity mild or severe presence of psychotic features melancholic or atypical features and peripartum or seasonal onset.

Non invasive brain stimulation therapies include repetitive Transcranial Magnetic Stimulation rTMS which is a non invasive brain stimulation technique using magnetic pulses. Types include single pulse paired pulse or repetitive stimulation. Theta burst stimulation involves high frequency bursts delivered at lower frequency and can be intermittent or continuous. Transcranial Direct Current Stimulation tDCS uses a weak electrical current to modulate neuronal activity through anode and cathode electrodes. Subthreshold effects alter resting membrane potentials influencing spontaneous neuronal firing and can induce lasting cortical changes beyond the stimulation period.
 
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