Health Condition 1: F321- Major depressive disorder, singleepisode, moderate
Conditions
Interventions
Intervention1: 3 days accelerated intermittent theta burst stimulation (iTBS): 15 sessions or 3 days of adjuvant iTBS(27000 pulses)
Control Intervention1: 5 days accelerated intermittent theta burst s
Sponsors
Dr Surobhi Chatterjee
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 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
| Measure | Time frame |
|---|---|
| A. Columbia Suicide Severity Score and Severe Cognitive Impairment in Psychiatry SCIP scale. B. BDNF levels C. Heart Rate VariabilityTimepoint: 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. | — |
Countries
India
Contacts
Public ContactSurobhi Chatterjee
All India Institute of Medical Sciences, Mangalagiri.
Outcome results
None listed