Exploring new treatment for depression and alcohol use disorders

Assessing the Role of Repetitive Transcranial Magnetic Stimulation on Aberrant Executive Function in the Context of Major Depressive Disorder in Adult Outpatients Seeking Treatment for Alcohol Use Disorder

This study is testing a new brain stimulation treatment for people with depression and alcohol problems to see if it can help improve their thinking and mood.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 59 Years
• Sex: All
• Sponsor: Centre for Addiction and Mental Health (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06299787 on ClinicalTrials.gov

What this trial studies

This study investigates the use of intermittent theta burst stimulation (TBS) as a novel intervention for individuals suffering from both major depressive disorder (MDD) and alcohol use disorder (AUD). By targeting the prefrontal cortex, which is implicated in cognitive dysfunction associated with these conditions, the study aims to enhance treatment outcomes. Participants will undergo TBS while their neurophysiological responses are monitored using integrated TMS-EEG to identify specific targets for intervention. The goal is to improve cognitive and psychological processes disrupted in these disorders.

Who should consider this trial

Good fit: Ideal candidates are outpatients aged 18 to 59 with a diagnosis of alcohol use disorder and major depressive episodes, who are stable on their current medications.

Not a fit: Patients with unstable medical conditions, pregnant individuals, or those with dementia may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could provide a new therapeutic option for patients struggling with both depression and alcohol use disorders.

How similar studies have performed: While the approach of using TBS for AUD is relatively novel, previous studies have shown promise in using TMS for treating depression, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. are outpatients;
2. are voluntary and competent to consent to treatment;
3. have a Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) diagnosis of AUD based on the MINI;
4. do not exhibit problematic use of any substances (excluding nicotine and caffeine), including alcohol, for \>1 month;
5. are male or female between the ages of 18 - 59;
6. screened positive for an MDE based on the MINI without psychotic symptoms
7. are agreeable to keeping their current antidepressant medications and medications for alcohol use disorder constant during the study;
8. are reliably taking SUD agonist therapies if appropriate and managed by their clinical team;
9. are able to adhere to the study schedule;
10. meet the TMS safety criteria.

Exclusion Criteria:

1. have a concomitant major unstable medical illness;
2. are pregnant or intend to get pregnant during the study;
3. have possible or probable dementia (based on the Informant Questionnaire on Cognitive Decline in the Elderly that will be administered to any participant with a baseline total score of \< 26 on the Montreal Cognitive Assessment (MoCA);
4. have failed a course of ECT, due to the lower likelihood of response to rTMS;
5. have any significant neurological disorder (e.g., a space occupying brain lesion, a history of stroke, a cerebral aneurysm, a seizure disorder, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant history of head trauma with radiological evidence of intracranial trauma at the time of injury due to risk of possible seizure foci from prior intracranial lesions.
6. present with a medical condition, a medication, or a laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, Cushing's disease);
7. have an intracranial implant (e.g., aneurysm clips, shunts, cochlear implants) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
8. require a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or higher or any anticonvulsant due to the potential of these medications to limit the efficacy of rTMS \[79\];
9. have an inability to communicate in English fluently enough to complete the clinical assessments.
10. have a MINI diagnosis or active symptoms of Bipolar Disorder

Where this trial is running

Toronto, Ontario

• Centre for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Daphne Voineskos, MD

Conditions Major Depressive Disorder; Alcohol Use Disorder