aTBS for Treatment of Depression in AUD

NCT03981185 | Withdrawn

• 1 other identifier: 47388
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for improvement of depressive symptoms and drinking behavior in individuals with alcohol dependence. In this open label study, all participants will receive accelerated theta-burst stimulation.

Conditions

Alcohol Use Disorder; Depression

Keywords

depression; TMS; transcranial magnetic stimulation; theta burst; alcohol use disorder; alcohol addiction

Outcome Measures

Primary Outcomes (2)

• Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)

  A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS uses a 0 to 6 severity scale, scored following the interview. Scoring/Interpretation: Higher scores indicate increasing depressive symptoms. ... Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.

  Baseline and immediate post-stimulation

• Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)

  A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS uses a 0 to 6 severity scale, scored following the interview. Scoring/Interpretation: Higher scores indicate increasing depressive symptoms. ... Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.

  Baseline and 1 month post-stimulation

Secondary Outcomes (5)

• Change in functional connectivity from baseline as measured by MR imaging

  Baseline and immediate post-stimulation

• Change in functional connectivity from baseline as measured by MR imaging

  Baseline and 1 month post-stimulation

• Change in alcohol craving and consumption measured by Obsessive Compulsive Drinking Scale (OCDS)

  Baseline and immediate post-stimulation

• Change in alcohol craving and consumption measured by Obsessive Compulsive Drinking Scale (OCDS)

  Baseline and 1 month post-stimulation

• Change in heart rate variability

  At the beginning and end of each stimulation day

Other Outcomes (8)

• Change from baseline in the Delis Kaplan Executive Function System (D-KEFS): Trail Making Test

  Baseline and immediate post-stimulation

• Change from baseline in the Delis Kaplan Executive Function System (D-KEFS): Trail Making Test

  Baseline and 1 month post-stimulation

• Change from baseline in the Hopkins Verbal Learning Test- Revised (HVLT-R)

  Baseline and immediate post-stimulation

Study Arms (1)

Accelerated theta burst treatment

EXPERIMENTAL

All participants will receive theta-burst TMS.

Device: Accelerated theta burst treatment

Interventions

Accelerated theta burst treatment DEVICE

All participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 80% of resting motor threshold adjust to the skull to cortical surface distance. Stimulation will be delivered to L-DLPFC using the MagPRo stimulator.

Accelerated theta burst treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

1. Participant aged 18-65 years old with diagnosis of alcohol use disorder. 2. Participant may also choose to or not to take pharmacotherapy during the study period. 3. Participant has tried at least one medication in the past that has not helped the alcohol use disorder. If participants are taking medication, they must be on stable psychotropic medication or psychotherapy for at least 6 weeks prior to the study with plans to continue throughout study enrollment. 4. Participant needs to be at least one week after last alcohol/ substance use and had the last drink within one year of the beginning of the study participation. 5. Participant endorses depressive symptom(s), indicated by a MARDS score \>= 20. 6. All participants must be assigned to a psychiatrist and agree to continue to be assigned to a psychiatrist throughout study enrollment. 7. Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Alcoholism; Depression

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Nolan Williams, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 12, 2019
• First Posted: June 10, 2019
• Study Start: January 1, 2024
• Primary Completion: July 11, 2024
• Study Completion: July 11, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share