Effect of Theta Burst Stimulation on depressive symptoms and craving in Alcohol Dependence with co-morbid Depression

Effect of adjunctive accelerated Theta Burst Stimulation at medial Prefrontal cortex on depressive symptoms and craving in Alcohol Dependence with comorbid Depression: an fMRI based randomized sham-controlled study - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060572

Enrollment

Registered

2023-12-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: F102- Alcohol dependence Health Condition 2: F341- Dysthymic disorder Health Condition 3: F33- Major depressive disorder, recurrent Health Condition 4: F32- Major depressive disorder, singleepisode

Interventions

Intervention1: THETA BURST STIMULATION: FP1 position of each participant will be localized using 10-20 EEG system. Resting motor threshold of right abductor pollicis brevis will be measured. The parti

Eligibility

Inclusion criteria

Inclusion criteria: 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 3.Ready to give informed consent 4.Right-handed

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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. 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. 3.Change in HAM-D scores from baseline to end of last cTBS session and 14 days from last cTBS session. 4.Change in MADRS scores from baseline to end of last cTBS session and 14 days from last cTBS session. 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	—

Measure

Time frame

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. 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. 3.Change in HAM-D scores from baseline to end of last cTBS session and 14 days from last cTBS session. 4.Change in MADRS scores from baseline to end of last cTBS session and 14 days from last cTBS session. 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

Measure	Time frame
1.Change in resting state functional connectivity of the Ventral Salience network and Default mode network from baseline to end of last cTBS session. 2.Change in cue-related functional connectivity of the Ventral Salience network from baseline to end of last cTBS session. 3.Changes in CGI-I scores from baselineTimepoint: Baseline, Day 8	—

Countries

India

Contacts

Public ContactDr Sourav Khanra

Central Institute of Psychiatry

basudebdas@cipranchi.nic.in09431108544

Outcome results

None listed

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