RecruitingNot applicable

Home-Based tDCS Treatment Of Major Depressive Disorder

Safety And Efficacy of Remotely Supervised Home-Based tDCS Treatment Of Major Depressive Disorder

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 weeks
  • Procedures mentioned: Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The participants are assessed with video interviews and self-reports during the study, which lasts for 10 weeks followed by an optional continuation period."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether Sooma tDCS, a brain stimulation treatment used at home, is safe and helps adults with major depression. It compares real treatment with a placebo treatment. The study lasts 10 weeks, with video interviews, self-reports, and an optional period to keep going.

The REACH-tDCS study will evaluate the safety and efficacy of a noninvasive, at-home self-administered Sooma tDCS brain stimulation treatment for Major Depressive Disorder. The study uses randomized, blinded, placebo controlled design. The participants are assessed with video interviews and self-reports during the study, which lasts for 10 weeks followed by an optional continuation period.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 22 to 70 years old and have major depressive disorder.
  • Have scores of at least 12 on the PHQ-9 and 20 on the MADRS, two depression rating tools.
  • Be taking an antidepressant. If you get talk therapy, it must be stable.
  • Have a smartphone or other device with Android 7.0 or newer, or iOS 13 or newer.
  • Be under the care of a psychiatrist or primary care doctor. Allow study staff to contact current and recent health care providers.
  • Give contact details for two adults who live within a 60-minute drive of your home.
  • Be able to understand, speak, and read enough English to complete study checks.
  • Sign a consent form, follow all study steps, and keep meeting the study's entry rules.

Who can't join

  • Depression that has not responded to treatment; other depression treatments beyond allowed medicines or talk therapy; or any past brain stimulation or ketamine/esketamine treatment for depression.
  • Current or past mania (an unusually high or irritable mood), psychosis (trouble knowing what is real), bipolar disorder, or obsessive-compulsive disorder. Autism, dementia, and certain other mental health conditions also exclude people.
  • Moderate or higher suicide risk, any past suicide attempt or hospital stay for suicidal behavior, or a stay over 24 hours in a psychiatric ward for depression.
  • Seizures, certain brain or skull problems, metal in the head, brain or skull implants, or powered medical implants such as a pacemaker.
  • Certain sleep problems, heart problems, hard-to-treat migraines, or vitamin or hormone shortages that may look like a mood disorder.
  • An alcohol or drug use disorder in the past year, ongoing nicotine use, or medicines that affect how easily brain cells become active.
  • Pregnancy, breastfeeding, plans for either during the study, or no medically accepted birth control if able to become pregnant.
  • Being in prison or jail; another clinical study within 90 days or during this study; trouble completing study forms; or hair that keeps the treatment cap from fitting closely.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

In short, Inclusion Criteria: * 22 - 70 years of age * Diagnosis of Unipolar MDD (DSM-V) * PHQ-9 score of ≥12 AND MADRS score of ≥ 20 at baseline * Antidepressant medication ongoing * If in psychotherapy, have maintained stable psychotherapy * Have access to a smartphone or other device running Android 7.0+ or iPhone Operating System (iOS) 13+ * Be under the care of a psychiatrist or a primary care physician * Allow communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two years * Provide the name and contact of at least two adult persons who reside within a 60-minute drive of the patient's residence. * Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study * Be willing and able to comply with all study procedures * Agree to meet all of the inclusion criteria throughout their participation in the study. Otherwise, the subject will be discontinued from the study * Be able to understand, speak, and read English sufficient for the completion of trial assessments Exclusion Criteria: * Current state of mania or psychosis, or have a history of mania or psychosis. * Treatment resistant depression. * Are diagnosed with vitamin or hormonal deficiencies that may mimic mood disorders, as determined by the investigator. * Be currently receiving any other interventional therapy for MDD other than a stable regimen of antidepressants or psychotherapy as defined in the inclusion criteria or have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain stimulation. * Have moderate or greater suicidality risk, or an attempt of suicide during lifetime or any previous hospitalization for suicidal behavior. * Diagnosis of sleep apnea with prescribed treatment (unless they are on CPAP treatment and are compliant with treatment) or a diagnosis of insomnia that is unrelated to depression, as determined by the investigator. * Have any structural lesion or any neurocranial defect or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results, as determined by the investigator. * Have any implant in the brain (e.g., DBS) or neurocranium, or any other active implantable medical device anywhere in the body (e.g. pacemaker, insulin pump). * Have a history of epilepsy or seizures. * Have shrapnel or any ferromagnetic material in the head. * Have any disorder that would impair the ability to complete the study questionnaires. * Have been diagnosed with autism spectrum disorder. * Have an alcohol use disorder or substance use disorder (past 12 months). * Have a cognitive impairment (including dementia). * medications that affect cortical excitability, as determined by the investigator. * Have ever taken esketamine / ketamine for treatment of depression. * Are currently admitted or have ever been admitted to a dedicated psychiatric ward for depression for a period of more than 24 hours. * Have ever been diagnosed with obsessive-compulsive disorder (OCD) or bipolar type 1 or 2 disorder. * Be diagnosed with PTSD, agoraphobia, anorexia or bulimia, panic or personality disorder, with active symptoms, based on the investigator's judgment. * Have any history of myocardial infarction, coronary artery bypass graft (CABG), coronary heart failure (CHF), or history of other cardiac issues. * Be currently experiencing or have a history of intractable migraines. * Be a chronic nicotine user. * Be currently pregnant or breastfeeding or planning to become pregnant or breastfeed any time during the study, or lack a medically acceptable method of contraception in females with child-bearing potential. * Be currently incarcerated. * Be participating concurrently in another clinical investigation or have participated in a clinical investigation within the last 90 days or intend to participate in another clinical investigation during the study. * Have a hairstyle or hair type, such as very thick hair or voluminous hairstyle, that would prevent wearing of the treatment cap tightly enough on the head that the electrodes are held close to the scalp.

Study sites (1)

MA