Conditions

Alcohol Use Disorder Depression

Keywords

depressionTMStranscranial magnetic stimulationtheta burstalcohol use disorderalcohol 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
+5 more other outcomes

Study Arms (1)

Accelerated theta burst treatment

EXPERIMENTAL

All participants will receive theta-burst TMS.

Device: Accelerated theta burst treatment

Interventions

Accelerated theta burst treatmentDevice

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Stanford University
Otherlead

MeSH Terms

Conditions

AlcoholismDepression

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

Nolan Williams, MD
Stanford University
PRINCIPAL INVESTIGATOR

Study Stopped

aTBS for Treatment of Depression in AUD

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Other Outcomes (8)

Study Arms (1)

Accelerated theta burst treatment

Interventions

Eligibility Criteria

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Other Outcomes (8)

Study Arms (1)

Accelerated theta burst treatment

Interventions

Eligibility Criteria

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record