| 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
|
|
|
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
|
|
|
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
|
|
|
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. |