RECRUITING

Transcranial Direct Current Stimulation for Depression

Description

This study will test the efficacy of transcranial direct current stimulation (tDCS) combined with mindfulness, remotely-delivered using a telemedicine protocol in 25 adults with unipolar depression.

Conditions

Unipolar Depression
Talk to us

Related Conditions:

Unipolar Depression

Study Overview

On this page

Study Details

Study overview

This study will test the efficacy of transcranial direct current stimulation (tDCS) combined with mindfulness, remotely-delivered using a telemedicine protocol in 25 adults with unipolar depression.

A Randomized, Double-blind, Parallel-arm, Sham-controlled Trial of ElectraRx Mindfulness Transcranial Direct Current Treatment System (Elect-MDS) for Adults With Major Depressive Disorder

Transcranial Direct Current Stimulation for Depression

Condition
Unipolar Depression
Intervention / Treatment

-

Contacts and Locations

Woodbridge

Soterix Medical, Inc., Woodbridge, New Jersey, United States, 07095

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Clinically stable patients that meet criteria for diagnosis of MDD according to DSM-V-TR and confirmed with the Mini International Neuropsychiatric interview
  • * Currently experiencing a major depressive episode of at least 4 week's duration as part of a unipolar depression
  • * QIDS-SR score \>11 on all three days of screening week (Days 1,3, 7)
  • * Scored at least 17 (inclusive) on the HDRS-17 at trial entry
  • * Any antidepressant medication is stable ≥ 30 days prior to HDRS-17 screening
  • * Female patients are allowed if not pregnant and using a medically acceptable method of contraception, if of childbearing potential.
  • * Current DSM-V-TR psychotic disorder
  • * Drug or alcohol abuse or dependence in the preceding 3 months
  • * Concurrent benzodiazepine medication
  • * High suicide risk assessed during clinician screening at baseline interview.
  • * Failure to respond to ECT treatment in this or any previous episode.
  • * Failure to respond to rTMS therapy in this or any previous episode.
  • * History of clinically defined neurological disorder or insult that may impact participation in this study as determined by study physician
  • * Metal in the cranium or skull defects
  • * Implanted pump, neurostimulator, cardiac pacemaker or defibrillator
  • * Skin lesions on scalp at the proposed electrode sites
  • * Pregnancy

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Soterix Medical,

Study Record Dates

2027-07-01