Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic features Health Condition 2: F331- Major depressive disorder, recurrent, moderate Health Condition 3: F333- Major depressive disorder, recurrent, severe with psychotic symptoms Health Condition 4: F321- Major depressive disorder, singleepisode, moderate Health Condition 5: F323- Major depressive disorder, singleepisode, severe with psychotic features Health Condition 6: F322- Major depressive disorder, single
Conditions
Interventions
Intervention1: Intermittent theta burst stimulation: iTBS will be delivered at 50 Hz at 80% of resting motor threshold for a train duration of 2secs using a figure-of-eight air-film coil.Each session
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1-Right handed. 2-Willing to give written informed consent. 3-Meeting DSM5 criteria for Major depressive disorder. 4-HAMD score more than 17. 5-Suffering from treatment resistant depression that is failed to respond to at least two antidepressant medication trial given for at least 6to8 weeks at adequate doses.
Exclusion criteria
Exclusion criteria: 1.Suffering from any other psychiatric disorder or substance use disorder (except caffeine and nicotine) through MINI 7.0 screening, Persistent mood disorder (dysthymia) and other and unspecified depression based on DSM5.2-History of seizures.3-Pregnancy/ lactation. 4-Unstable medical illness. 5-History suggestive of space occupying brain lesion or cerebrovascular accidents. 6-Patient having implanted device or metal in brain/ head or cardiac pacemaker.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HAMD ScoreTimepoint: Baseline assessment will be done within a week prior to initiating iTBS. Assessment will be repeated within 24 hours at end of 5th session and within 24 hours of last session i.e. 15th session. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-Change in Serum BDNF level. 2-Change in CGI AND MOCA scores.Timepoint: 1- 2 ml Blood would be taken within a week prior to initiating iTBS and serum would be separated for measurement of serum BDNF level and it would be repeated within a week of completion of 15th session. 2-Baseline assessment will be done within a week prior to initiating iTBS. Assessment will be repeated within 24 hours at end of 5th session and within 24 hours of last session i.e. 15th session. | — |
Countries
India
Contacts
Public ContactDr Nand kumar
All India Institute of Medical Sciences
Outcome results
None listed