Transcranial Direct Current Stimulation for Depression

Soterix Medical

Status: Enrolling

Conditions: Unipolar Depression

Treatments: Device: transcranial direct current stimulation (tDCS) and mindfulness instruction; Device: Sham tDCS and Mindfulness

Study type: Interventional

Funder types: Industry

Identifiers

NCT07042217

ELECTMDS

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups

Active tDCS and Mindfulness

Experimental group

Description:

Application of electrical stimulation to the brain non-invasively combined with mindfulness

Treatment:

Device: transcranial direct current stimulation (tDCS) and mindfulness instruction

Sham tDCS and Mindfulness

Sham Comparator group

Description:

Sham electrical stimulation and mindfulness

Treatment:

Device: Sham tDCS and Mindfulness