Status:
COMPLETED
Home-administered tDCS for Treatment of Depression
Lead Sponsor:
Soterix Medical
Collaborating Sponsors:
NYU Langone Health
Conditions:
Unipolar Depression
Treatment Resistant Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will determine the safety and efficacy of home administered tDCS in adults with unipolar depression. The device used to administer tDCS will be the Soterix Medical 1X1 mini-CT. 32 tDCS sess...
Detailed Description
The Soterix Medical 1X1 mini-CT will be used to determine the safety and efficacy of home-based transcranial direct current stimulation (tDCS) in treating unipolar depression. Specifically efficacy wi...
Eligibility Criteria
Inclusion
- 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
- Scored at least 20 on the MADRS at trial entry
- Patient's antidepressant medication is stable for at least 30 days prior to MADRS screening
- Female patients are allowed if not pregnant and are using a medically acceptable method of contraception, if of childbearing potential
Exclusion
- DSM-V-TR psychotic disorder
- Drug or alcohol abuse or dependence in the preceding 3 months
- Concurrent benzodiazepine medication
- High suicide risk
- History of clinically defined neurological disorder or insult
- Metal in the cranium or skull defects
- Subjects with an implanted pump, neurostimulator, cardiac pacemaker or defibrillator
- Skin lesions on scalp at the proposed electrode sites
- Pregnancy
Key Trial Info
Start Date :
February 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04781127
Start Date
February 10 2021
End Date
August 10 2022
Last Update
January 30 2023
Active Locations (1)
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1
New York University
New York, New York, United States, 10011