NCT06976697

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

May 7, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 27, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2026

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

May 7, 2025

Last Update Submit

March 20, 2026

Conditions

Major Depressive Disorder (MDD)

Keywords

DepressionBrain stimulationBrainSoomatDCStES

Outcome Measures

Primary Outcomes (1)

  • MADRS: change from baseline

    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.

    10 weeks from treatment initiation.

Secondary Outcomes (9)

  • MADRS: rate of response

    10 weeks from treatment initiation.

  • MADRS: rate of remission

    10 weeks from treatment initiation.

  • HAM-D17: change form baseline

    10 weeks from treatment initiation.

  • HAM-D17: rate of response

    10 weeks from treatment initiation.

  • HAM-D17: rate of remission

    10 weeks from treatment initiation.

  • +4 more secondary outcomes

Study Arms (2)

Active treatment

EXPERIMENTAL
Device: Transcranial direct current stimulation

Sham treatment

SHAM COMPARATOR
Device: Sham transcranial direct current stimulation

Interventions

Transcranial direct current stimulationDEVICE

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.

Active treatment
Sham transcranial direct current stimulationDEVICE

Sham treatment mimics the active device use and the experiences from the active stimulation while minimizing active effects.

Sham treatment

Eligibility Criteria

Age22 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Be able to understand, speak, and read English sufficient for the completion of trial assessments

You may not qualify if:

  • 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.
  • 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.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lindus Health (virtual study site)

Boston, Massachusetts, 02111, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Christopher Reist, M.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2025

First Posted

May 16, 2025

Study Start

June 27, 2025

Primary Completion (Estimated)

October 10, 2026

Study Completion (Estimated)

December 23, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

The IPD used in the results of the publication will be shared.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
Beginning 1 year and ending 3 years after the publication of results.
Access Criteria
The deidentified IPD and the data dictionary will be provided for non-commercial use, via a data request, once an appropriate analysis plan has been provided and it has been approved by independent review and the study sponsor and a data sharing agreement has been signed. Data sharing will abide by the rules and policies defined by the sponsor, and relevant institutional review boards, as well as local, state and federal laws and regulations. Rights and privacy of individuals participating in the research will be protected at all times.

Locations

US(1)