Innovative electrical stimulation for treatment-resistant depression

Dose-Optimized and Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression

This study is testing a new type of electrical stimulation treatment for people with depression who haven't found relief from other therapies to see if it can help improve their symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University of California, San Diego (other)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT06730841 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility, safety, and tolerability of a novel approach called Dose-Optimized and Spaced Transcranial Direct Current Stimulation (DOS-tDCS) for treating Major Depressive Disorder (MDD) in patients who have not responded to traditional therapies. It is a 3-arm randomized controlled trial comparing the effects of DOS-tDCS, spaced tDCS, and sham tDCS on depressive symptoms. Participants will receive low-intensity electrical currents applied through the scalp, with the aim of achieving a significant reduction in depressive symptoms. The study will assess the antidepressant effects of this innovative protocol in individuals diagnosed with treatment-resistant depression.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 85 diagnosed with Major Depressive Disorder who have a history of moderate treatment resistance.

Not a fit: Patients who do not have Major Depressive Disorder or those who are not treatment-resistant may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new effective treatment option for patients suffering from treatment-resistant depression.

How similar studies have performed: While this approach is innovative, similar studies using transcranial direct current stimulation have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. People between the ages of 18 and 85 at the time of screening.
2. Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
3. Currently diagnosed with Major Depressive Disorder (MDD) and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).
4. Medical records confirming a history of at least moderate treatment-resistance as defined an Antidepressant Treatment History Form (ATHF) score for that antidepressant trial of \> 2 in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF score of 1 or 2 on those 2 separate antidepressants) OR have a combination of one failed trial and one not tolerated trial, per the definitions above.
5. MADRS score of ≥20 at screening (Visit 1).
6. Existing relationship with mental health provider and access to ongoing psychiatric care before and after completion of the study.
7. Must be on a stable antidepressant therapeutic regimen, or not receiving treatment for 4 weeks prior to study enrollment and agree to continue this regimen throughout the study period.
8. In good general health, as evidenced by medical history.
9. For persons of child-bearing potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
10. Agreement to adhere to Lifestyle Considerations (i.e. must continue with any existing treatments) throughout study duration.
11. For persons of child-bearing potential: must take a pregnancy test at the screening visit, with results confirmed as negative by study staff.

Exclusion Criteria:

An individual will be excluded from participation in this study if they meet any of the following criteria, as determined from a review of medical records prior to screening or at the screening visit:

1. Pregnancy;
2. History of psychotic or bipolar disorder or depression with psychotic features;
3. Significant borderline personality disorder;
4. Significant comorbid obsessive-compulsive or post-traumatic stress disorder;
5. Previously diagnosed Intellectual Disability or Autism Spectrum Disorder;
6. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal;
7. Clinically significant suicidality;
8. Any history of tDCS;
9. Any history of ECT;
10. History of TMS (greater than 15 sessions) without a clinically meaningful response.
11. History of ketamine (greater than 4 sessions) without a clinically meaningful response;
12. Chronic depression (defined as of over 5 years duration);
13. History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent symptoms;
14. Untreated or insufficiently treated endocrine disorder;
15. Contraindication to receiving tDCS (e.g., ferromagnetic implant, history of seizure, known brain lesion);
16. Treatment with an investigational drug or other intervention within the study period;
17. Unstable symptoms between screening and baseline as defined by a ≥ 30% change in MADRS score;
18. Require a benzodiazepine with a dose \> lorazepam 2 mg/day
19. Has started a new psychotherapeutic process in the past 3 months from screening;
20. Use of potentially irritant topical treatments (ex: retinoids, alpha hydroxy acids)
21. Aesthetic procedure the area of the forehead directly below the stimulation area within the last 6 months (laser, fillers, surgery, etc.)
22. Any active dermatological condition on face or scalp that would in the opinion of the PI represent a contraindication to the treatment.

Where this trial is running

San Diego, California

• UCSD Interventional Psychiatry — San Diego, California, United States (RECRUITING)

Study contacts

• Study coordinator: Interventional Psychiatry

Conditions: Treatment Resistant Depression, Major Depressive Disorder