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A study evaluating the predictors of response to iTBS in patients with treatment resistant depression

Predictors of response to intermittent theta burst stimulation(iTBS) in Treatment Resistant Depression(TRD) patients using 18F-FDG PET Scan: An Open Label Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032678
Enrollment
30
Registered
2021-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F341- Dysthymic disorder Health Condition 2: F332- Major depressive disorder, recurrent severe without psychotic features Health Condition 3: F331- Major depressive disorder, recurrent, moderate Health Condition 4: F333- Major depressive disorder, recurrent, severe with psychotic symptoms Health Condition 5: F321- Major depressive disorder, singleepisode, moderate Health Condition 6: F323- Major depressive disorder, singleepisode, severe with psychotic features Health Conditi

Interventions

Intervention1: intermittent theta burst stimulation(iTBS): iTBS will be delivered at 50hz at 80% of resting motor threshold for a train duration of 2 secs using a figure-of-eight air-film coil. Each s

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Right-handed 2.Willing to give written informed consent 3.Meeting DSM5 criteria for Major Depressive Disorder(MDD) 4.Suffering from TRD i.e. failed to response to at least 2 antidepressant medication trials given for at least 6-8 weeks at adequate dose 5.Hamilton Depression Rating Scale score >17 (moderate to severe depression)

Exclusion criteria

Exclusion criteria: 1.Suffering from any other psychiatric disorder or substance use disorder(except caffeine or nicotine) through MINI 7.0 screening 2.History of epileptic seizures 3.Pregnancy/Lactation 4.History of neurological disorders or substantial brain damage 5.Any present uncontrolled medical condition 6.Contraindication to magnetic fields, according to established safety criteria as per Rossi et al 2009 study

Design outcomes

Primary

MeasureTime frame
Changes in PET/CT scanTimepoint: Assessment will be done at baseline, at 1 week after 5th session of rTMS and at 3 weeks after last session

Secondary

MeasureTime frame
Change in HAMD scoreTimepoint: Assessment will be done at baseline, at 1 week after 5th session of rTMS and at 3 weeks after last session

Countries

India

Contacts

Public ContactDr Nidhisha Bajaj

AIIMS New Delhi

nandkm2001@gmail.com9899943146

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026