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CTRI Number  CTRI/2024/11/076657 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 10/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Adjunctive accelerated intermittent theta burst stimulation and depression: comparison of three days vs five days protocol.  
Scientific Title of Study   Effect of three days vs five days adjunctive accelerated intermittent theta burst stimulation (aiTBS) on outcomes in patients with depression a randomized Controlled Open Label Interventional Trial  
Trial Acronym  D-iTBS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Surobhi Chatterjee  
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences, Mangalagiri.  
Address  Department of Psychiatry Ayush block All India Institute of Medical sciences Mangalagiri, Andra Pradesh, India

Guntur
ANDHRA PRADESH
522503
India 
Phone  9653035143  
Fax    
Email  surochat98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vijay Chandra Reddy Avula  
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences, Mangalagiri.  
Address  Department of Psychiatry Ayush block All India Institute of Medical sciences Mangalagiri, Andra Pradesh, India

Guntur
ANDHRA PRADESH
522503
India 
Phone  9492860420  
Fax    
Email  dean.sw@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Public Query
 
Name  Surobhi Chatterjee  
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences, Mangalagiri.  
Address  Department of Psychiatry Ayush block All India Institute of Medical sciences Mangalagiri, Andra Pradesh, India

Guntur
ANDHRA PRADESH
522503
India 
Phone  9653035143  
Fax    
Email  surochat98@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Dr Surobhi Chatterjee 
Address  Department of Psychiatry Al India Institute of Medical sciences, Mangalagiri, Andra Pradesh, Pin- 522503 
Type of Sponsor  Other [Primary Investigator- Dr Surobhi Chatterjee] 
 
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 Surobhi Chatterjee  All India Institute of Medical Sciences  Near Old TB Sanatorium, AIIMS Mangalagiri, Andhra Pradesh, 522503 Pin- 522503
Krishna
ANDHRA PRADESH 
9653035143

surochat98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of AIIMS Mangalagiri   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  3 days accelerated intermittent theta burst stimulation (iTBS)  15 sessions or 3 days of adjuvant iTBS(27000 pulses) 
Comparator Agent  5 days accelerated intermittent theta burst stimulation (aiTBS)  5 days or 25 sessions of adjuvant iTBS(45000 pulses) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. A diagnosis of Depressive Disorder or Bipolar depression type 1 or type 2 according to the International Classification of Diseases (ICD-11) which is assessed by at least one professional psychiatrist.

2. For Single Depressive disorder, moderate or severe, or Bipolar mood disorder, current episode depressive - clinically inadequate or non-responders to standard clinical treatment will be involved. Partial or complete non- responders to at least one (i.e., poor response) or more (i.e., treatment resistance) antidepressant treatment (given at therapeutic doses for at least 8 weeks) or people on recommended dosing of lithium and mood stabilisers will be considered during the current episode.

3. Age ≥18 years

4. Informed consent to participate in the study.

5. HAMD-17 score ≥ 17

6. Willing to remain on maintenance pharmacotherapy for at least 2 weeks before the stimulation initiation and during the total stimulation period.
 
 
ExclusionCriteria 
Details  2 EXCLUSION CRITERIA-
1. Absence of neurological disorders like epilepsy or a family history of epilepsy, previous notable head injuries, brain surgery, and periods of unconsciousness lasting at least 15 minutes.
2.Presence of current psychosis as diagnosed
by the ICD-11; or a history of a non-mood psychotic disorder.
3. Pregnancy or breastfeeding
4. Undergoing or having undergone modified
electroconvulsive therapy (MECT) or
repetitive transcranial magnetic stimulation
(rTMS) within the last month;
5. The existence of a pacemaker or any other
electrical stimulation device, metallic
clips.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
compare the clinical efficacy of accelerated intermittent theta burst stimulation repetitive transcranial magnetic stimulation in patients with depression using Hamiliton Depression severity (HAM-D) score.
 
1. Baseline - before commencing iTBS
2. After 15/25 sessions (3/5 days) of iTBS- completion of all sessions.
3. 8 weeks - follow up  
 
Secondary Outcome  
Outcome  TimePoints 
A. Columbia Suicide Severity Score and Severe Cognitive Impairment in Psychiatry SCIP scale.

B. BDNF levels
C. Heart Rate Variability  
A. 1. Baseline - before commencing iTBS
2. After 15/25 sessions (3/5 days) of iTBS- completion of
all sessions.
3. 8 weeks - follow up
B. BDNF levels
1. Baseline - before commencing iTBS
2. 8 weeks - follow up

C. Heart rate variability
1. Baseline - before commencing iTBS
2. After 15/25 sessions (3/5 days) of iTBS- 1 day after completion of all sessions.
 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   21/11/2024 
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)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

India reportedly has the highest prevalence of suicide in Southeast Asia with a reported prevalence of 11.3 per 100,000 population in 2020, much higher than the global average (Menon et al, 2023). Emerging evidence suggests that iTBS exhibits superior clinical efficacy in managing major depressive disorder (MDD) when contrasted with traditional rTMS approaches (Di Lazzaro et al., 2011; Chung et al., 2015; Prasser et al., 2015). A notable advantage of TBS is its reduced administration duration relative to conventional rTMS procedures. The rTMS applied to bilateral right-sided cTBS and left-sided iTBS of the DLPFC in major unipolar depression is regarded as a probable, Level B recommendation whereas unilateral right-sided cTBS is possibly ineffective Level C. Research has explored the potential therapeutic benefits of modulating Brain-Derived Neurotrophic Factor (BDNF) levels through Repetitive Transcranial Magnetic Stimulation (rTMS) in the context of depression (Chen et al,2017, Numbero et al, 2021). HR variability is proposed as a novel cardiovascular biomarker. (Sheen et al, 2022). Previous studies have compared High-frequency rTMS vs Low-frequency rTMS for assessing neurocognitive decline, clinical improvement, and suicide risk. One study has evaluated the levels of BDNF in augmented repetitive transcranial magnetic stimulation using high-frequency rTMS (4).

However, as per our analysis, most reported studies have only followed antidepressant effects for 4 weeks (18). Ours will have an 8-week follow-up period and attempt to assess the response to an aITBS session. This will help identify response rates and frequency intervals for aiTBS sessions. There have been limited reported studies comparing the clinical efficacy of two different protocols of accelerated iTBS and a few ongoing trials that are using both - heart rate variability and serum BDNF levels in patients diagnosed with depression and their potential role as biomarkers in indication treatment response.

 

 

 
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