Transcranial Direct Current Stimulation for 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

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.

Interventions

• Device transcranial direct current stimulation (tDCS) and mindfulness instruction
  tDCS together with audio providing mindfulness instruction and music
• Device Sham tDCS and Mindfulness
  Placebo electrical sitmulation and audio-guided mindfulness instruction

Primary outcome measures

• Hamilton Depression Rating Scale (HDRS) [Time frame: Week 4 and Week 7]
• Blinding Integrity [Time frame: Week 7]

Secondary outcome measures (6)

• Response and Remission rates defined by HDRS [Time frame: Week4, Week 7, Week 10, and Week 13]
• Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) [Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13]
• Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF [Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13]
• Clinical Global Impression severity (CGI-S) and improvement (CGI-I) subscales [Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13]
• Sheehan Disability Scale (SDS) [Time frame: Baseline, Week 7, and Week 13]
• Montgomery-Asburg Depression Rating Scale (MADRS) [Time frame: Baseline, Week 7 and Week 13]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Soterix Medical, Inc. — Woodbridge

Identifiers

NCT: NCT07042217 · ELECTMDS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗