Major Depressive Disorder (MDD)
Conditions
Keywords
Depression, Brain stimulation, Brain, Sooma, tDCS, tES
Brief summary
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.
Detailed description
The study stages include: screening, eligibility evaluation, randomization to active or sham arm (1:1), the first treatment period (weeks 1-10) with sham-control and the optional open-label phase (weeks 11-20) where all treatments will be in active mode.
Interventions
DEVICETranscranial direct current stimulation
In tDCS treatment session electrical current (2 mA) is applied for 30 minutes through two electrodes placed on top of scalp to modulate neural activity.
DEVICESham transcranial direct current stimulation
Sham treatment mimics the active device use and the experiences from the active stimulation while minimizing active effects.
Sponsors
Sooma Medical Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 70 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MADRS: change from baseline | 10 weeks from treatment initiation. | Mean change in depressive symptoms, measured by the Montgomery-Asberg Depression Rating Scale (MADRS) total score, from baseline to week 10. MADRS ranges from 0 to 60, with higher scores indicating more severe depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MADRS: rate of response | 10 weeks from treatment initiation. | Rate of response defined as the percent of subjects achieving at least 50% reduction from baseline in their MADRS at week 10. |
| MADRS: rate of remission | 10 weeks from treatment initiation. | Rate of remission remission defined as the percent of subjects with MADRS score ≤ 10 at week 10. |
| HAM-D17: change form baseline | 10 weeks from treatment initiation. | Mean change in depressive symptoms, measured by Hamilton Depression Rating Scale (17-items) (HAM-D17), from baseline to week 10. HAM-D17 ranges from 0 to 52, with higher scores indicating more severe depression. |
| HAM-D17: rate of response | 10 weeks from treatment initiation. | Rate of response defined as the percent of subjects achieving at least 50% reduction from baseline in their HAM-D17 at week 10. |
| HAM-D17: rate of remission | 10 weeks from treatment initiation. | Rate of remission defined as the percent of subjects with HAM-D17 score ≤ 7 at week 10. |
| PHQ-9: change from baseline | 10 weeks from treatment initiation. | Mean change in depressive symptoms, measured by Patient Health Questionnaire-9 (PHQ-9) total score, from baseline to week 10. PHQ-9 ranges from 0 to 27, with higher scores indicating more severe depression. |
| PHQ-9: rate of response | 10 weeks from treatment initiation. | Rate of response defined as the percent of subjects achieving at least 50% reduction from baseline in their PHQ-9 at week 10. |
| PHQ-9: rate of remission | 10 weeks from treatment initiation. | Rate of remission, defined as the percent of subjects with PHQ-9 score ≤ 4 at week 10. |
| CGI-I | 10 weeks from treatment initiation. | The clinical global impression - improvement scale (CGI-I) is a 7-point scale allowing the clinical rater to assess how much the patient's overall condition has improved or worsened since starting the intervention (1. very much improved, 2. much improved, 3. minimally improved, 4. no change, 5. minimally worse, 6. much worse, 7. very much worse). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristopher Reist, M.D.
Outcome results
None listed