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

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Dec 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people with Major Depressive Disorder (MDD) who have not found relief from traditional therapies. The researchers are testing a method called Dose-Optimized and Spaced Transcranial Direct Current Stimulation (DOS-tDCS), which involves applying low-level electrical currents to the scalp. This innovative approach is expected to help reduce depressive symptoms more effectively than standard treatments. Participants will be randomly assigned to one of three groups: one receiving the new DOS-tDCS treatment, another getting a different version of tDCS, and a control group receiving a placebo treatment. The study will last for six weeks.

To be eligible for this trial, participants need to be between 18 and 85 years old, currently diagnosed with MDD, and have a history of not responding well to at least two different antidepressant treatments. They should be in good overall health and have a stable relationship with a mental health provider. Participants can expect to attend sessions where they will receive treatment and complete questionnaires about their mood and well-being. It's important to note that certain medical conditions and treatments may exclude individuals from participating, so potential volunteers should discuss their medical history with the study team. This trial aims to provide a new option for those struggling with treatment-resistant depression.

Gender

ALL

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.