Home-Based tDCS Treatment Of Major Depressive Disorder

Inclusion Criteria:

• 22 - 70 years of age

• Diagnosis of Unipolar MDD (DSM-V)

• PHQ-9 score of ≥13 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 OperatingSystem (iOS) 13+

• Be under the care of a psychiatrist or a primary care physician

• Allow communication between the investigators/study staff and any healthcareprovider who currently provides and/or has provided service to the patient/subjectwithin 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 signedan 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 thestudy. Otherwise, the subject will be discontinued from the study

• Be able to understand, speak, and read English sufficient for the completion oftrial 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 stableregimen of antidepressants or psychotherapy as defined in the inclusion criteria orhave a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct currentstimulation (tDCS), deep brain stimulation (DBS), or other brain stimulation.

• Have moderate or greater suicidality risk, or an attempt of suicide during lifetimeor any previous hospitalization for suicidal behavior.

• Have sleep apnea (unless they are on CPAP treatment and are compliant withtreatment) or a diagnosis of insomnia that is unrelated to depression, as determinedby the investigator.

• Have any structural lesion or any neurocranial defect or any other clinicallysignificant abnormality that might affect safety, study participation, or confoundinterpretation of study results, as determined by the investigator.

• Have any implant in the brain (e.g., DBS) or neurocranium, or any other activeimplantable 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 studyquestionnaires.

• 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 the hospital for depression.

• Have ever been diagnosed with obsessive-compulsive disorder (OCD) or bipolar type 1or 2 disorder.

• Be diagnosed with an active primary anxiety disorder, or PTSD, agoraphobia, anorexiaor bulimia, panic or personality disorder with active symptoms, based on theinvestigator'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 tobacco smoker.

• Be currently pregnant or breastfeeding or planning to become pregnant or breastfeedany time during the study, or lack a medically acceptable method of contraception inprovider 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.
 

• Have sleep apnea (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 the hospital for depression.
 

• Have ever been diagnosed with obsessive-compulsive disorder (OCD) or bipolar type 1
or 2 disorder.
 

• Be diagnosed with an active primary anxiety disorder, or 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 tobacco smoker.
 

• 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 participatedin a clinical investigation within the last 90 days or intend to participate inanother clinical investigation during the study.

• Have a hairstyle or hair type, such as very thick hair or voluminous hairstyle, thatwould prevent wearing of the treatment cap tightly enough on the head that theelectrodes are held close to the scalp.