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Transcranial Direct Current Stimulation for 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests tDCS, a treatment that uses a weak electrical current to stimulate the brain, along with mindfulness. It is for 25 adults with unipolar depression, which means depression without manic episodes. Treatment is provided remotely through telemedicine.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have major depressive disorder confirmed by a clinical interview, and be medically stable.
  • Have a current episode of unipolar depression lasting at least 4 weeks.
  • Score above 11 on the QIDS-SR depression survey on screening days 1, 3, and 7.
  • Score at least 17 on the HDRS-17 depression rating scale when entering the study.
  • If taking antidepressant medicine, have no changes for at least 30 days before the HDRS-17 screening.
  • If able to become pregnant, not be pregnant and use a medically accepted birth control method.

Who can't join

  • Have tried at least 2 antidepressant medicines that did not help.
  • Have had drug or alcohol abuse or dependence in the past 3 months, or currently take a benzodiazepine medicine.
  • Be at high risk of suicide, as judged by a clinician during screening.
  • Have had ECT (electrical brain treatment) or rTMS (magnetic brain stimulation) that did not help during any depression episode.
  • Currently have a psychotic disorder, which can affect what you believe or perceive as real.
  • Have a past brain or nerve disorder or injury that the study doctor thinks may affect participation.
  • Have metal in the skull, a skull defect, or an implanted pump, nerve stimulator, pacemaker, or defibrillator.
  • Have damaged skin on the scalp where the electrodes would go, or be pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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. Exclusion Criteria: * Failure to respond to at least 2 antidepressant medications * 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 or rTMS treatment in this or any previous episode. * Current DSM-V-TR psychotic disorder * 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

Study sites (1)

NJ