Effect of Theta Burst Stimulation on depressive symptoms and craving in Alcohol Dependence with co-morbid Depressio
- Conditions
- Health Condition 1: F102- Alcohol dependenceHealth Condition 2: F341- Dysthymic disorderHealth Condition 3: F33- Major depressive disorder, recurrentHealth Condition 4: F32- Major depressive disorder, singleepisode
- Registration Number
- CTRI/2023/12/060572
- Lead Sponsor
- Central Institute of Psychiatry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients diagnosed with Mental and Behavioral disorders due to use of alcohol, dependence syndrome, currently using the substance-active dependence (F10.24), along with, Depressive episode (F32) or Recurrent depressive disorder (F33) or Dysthymia (F34.1) according to ICD-10.
2.Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) score <10
3.Ready to give informed consent
4.Right-handed
1.Any other co-morbid substance abuse except Nicotine and Caffeine.
2.Any co-morbid psychiatric disorders except the ones mentioned in Inclusion criteria 1.
3.Patients having metallic implant.
4.Patients having known contra-indications to undergoing Theta Burst Stimulation or fMRI.
5.History of Electro-convulsive therapy or other Neuromodulation techniques within last 3 weeks.
6.Patient on any anti-craving medication during study period and preceding 4 weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change in the score of Alcohol Craving Questionnaire (ACQ-NOW) from baseline to end of last cTBS session and after 14 days from last cTBS session. <br/ ><br>2.Change in the score of obsessive-compulsive drinking scale (OCDS) from baseline to the end of last cTBS session and 14 days from last cTBS session. <br/ ><br>3.Change in HAM-D scores from baseline to end of last cTBS session and 14 days from last cTBS session. <br/ ><br>4.Change in MADRS scores from baseline to end of last cTBS session and 14 days from last cTBS session. <br/ ><br>5.Change in HAM-A scores from baseline to end of last cTBS session and 14 days from last cTBS session.Timepoint: Baseline, Day 8, Day 21
- Secondary Outcome Measures
Name Time Method 1.Change in resting state functional connectivity of the Ventral Salience network and Default mode network from baseline to end of last cTBS session. <br/ ><br>2.Change in cue-related functional connectivity of the Ventral Salience network from baseline to end of last cTBS session. <br/ ><br>3.Changes in CGI-I scores from baselineTimepoint: Baseline, Day 8