A study evaluating the effect of iTBS in patient with treatment resistant depressio
- Registration Number
- CTRI/2019/04/018367
- Lead Sponsor
- All India Institute of Medical Sciences New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1-Change in Serum BDNF level. <br/ ><br>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.