RECRUITING

Transcranial Direct Current Stimulation for Depression

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Conditions

Unipolar DepressiontDCSmindulnesstESelectrotherapydepression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-07-01
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07042217

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.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinically stable patients that meet criteria for diagnosis of MDD according to DSM-V-TR and confirmed with the Mini International Neuropsychiatric interview
  2. * Currently experiencing a major depressive episode of at least 4 week's duration as part of a unipolar depression
  3. * QIDS-SR score \>11 on all three days of screening week (Days 1,3, 7)
  4. * Scored at least 17 (inclusive) on the HDRS-17 at trial entry
  5. * Any antidepressant medication is stable ≥ 30 days prior to HDRS-17 screening
  6. * Female patients are allowed if not pregnant and using a medically acceptable method of contraception, if of childbearing potential.
  1. * Current DSM-V-TR psychotic disorder
  2. * Drug or alcohol abuse or dependence in the preceding 3 months
  3. * Concurrent benzodiazepine medication
  4. * High suicide risk assessed during clinician screening at baseline interview.
  5. * Failure to respond to ECT treatment in this or any previous episode.
  6. * Failure to respond to rTMS therapy in this or any previous episode.
  7. * History of clinically defined neurological disorder or insult that may impact participation in this study as determined by study physician
  8. * Metal in the cranium or skull defects
  9. * Implanted pump, neurostimulator, cardiac pacemaker or defibrillator
  10. * Skin lesions on scalp at the proposed electrode sites
  11. * Pregnancy

Contacts and Locations

Study Contact

Paul Thomas R&D Engineer
CONTACT
18889908327
trials@soterixmedical.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Soterix Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2025-07-01
Study Completion Date2027-07-01

Terms related to this study

Keywords Provided by Researchers

  • tDCS
  • mindulness
  • tES
  • electrotherapy
  • depression

Additional Relevant MeSH Terms

  • Unipolar Depression