RECRUITING

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

Conditions

Treatment Resistant Depression Major Depressive Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to evaluate the feasibility, safety, and tolerability of an innovative approach to treating Major Depressive Disorder (MDD), particularly in cases where patients have not responded well to traditional therapies. Specifically, the objective is to evaluate the antidepressant effects of a Dose-Optimized and Spaced Transcranial Direct Current Stimulation (DOS-tDCS) protocol in participants with treatment-resistant depression (TRD) compared to spaced tDCS only and sham tDCS in a 3-arm randomized controlled trial (RCT). The proposed method involves applying low-intensity electrical currents through the scalp in a manner that is both more intense and more frequently spaced than standard treatments. This approach is hypothesized to lead to a significant reduction in depressive symptoms. Participants in the study will be randomly assigned to one of three groups: the experimental group receiving the DOS-tDCS treatment, a group receiving spaced tDCS only, or a control group receiving a sham (placebo) treatment. Outcomes will be measured over a period of six weeks. The study's goal is to offer a potentially more accessible and effective treatment option for individuals who have not benefited from existing MDD therapies.

Official Title

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

Quick Facts

Study Start:2024-09-26

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06730841

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Interventional Psychiatry

CONTACT

858-966-5832

iptrials@health.ucsd.edu

Study Locations (Sites)

UCSD Interventional Psychiatry

San Diego, California, 92127

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-26

Study Completion Date2027-09

Study Record Updates

Study Start Date2024-09-26

Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

Treatment Resistant Depression
Major Depressive Disorder