Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2025-07-01
2026-09-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active tDCS and Mindfulness
Application of electrical stimulation to the brain non-invasively combined with mindfulness
transcranial direct current stimulation (tDCS) and mindfulness instruction
tDCS together with audio providing mindfulness instruction and music
Sham tDCS and Mindfulness
Sham electrical stimulation and mindfulness
Sham tDCS and Mindfulness
Placebo electrical sitmulation and audio-guided mindfulness instruction
Interventions
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transcranial direct current stimulation (tDCS) and mindfulness instruction
tDCS together with audio providing mindfulness instruction and music
Sham tDCS and Mindfulness
Placebo electrical sitmulation and audio-guided mindfulness instruction
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
ALL
No
Sponsors
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Soterix Medical
INDUSTRY
Responsible Party
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Locations
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Soterix Medical, Inc.
Woodbridge, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Paul Thomas
Role: primary
Related Links
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Sponsor's webpage with information about the study
Other Identifiers
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ELECTMDS
Identifier Type: -
Identifier Source: org_study_id