| 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
|
|
|
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
|
|
|
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. |