Home-administered tDCS for Treatment of Depression

Soterix Medical

Status and phase

Completed

Phase 1

Conditions

Treatment Resistant Depression

Unipolar Depression

Treatments

Device: Soterix Medical mini-CT tDCS stimulator

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04781127

SMI-F10

Details and patient eligibility

About

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 sessions of 30 minutes each will be delivered over 10 weeks.

Full 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 will be determined by change in MADRS score from baseline to the 10 week follow-up. Feasibility and compliance will be determined by low drop out rate and percentage of scheduled sessions completed. Self-reported mood scores will be evaluated using the Quick Inventory of Depressive Symptomatology (QIDS-SR) and Quality of Life enjoyment and Satisfaction Questionnaire Form (Q-LES-Q-SF). All visits will be performed via telephone or video conference. Subjects will be taught to operate the tDCS system and complete a tolerability check. The treatment course will consist of an acute phase of 28 tDCS sessions conducted Monday - Friday over 6 weeks. This is followed by a taper of 4 tDCS sessions spaced 1 week apart. Patients who meet criteria for clinical response (>=50% improvement in MADRS) may continue with maintenance treatments of once a week for 2 months and once every 2 weeks for the remaining 3 months. Mood assessments will be conducted at baseline, 2 weeks, 4 weeks and 6 weeks in the acute treatment phase. In the taper phase, assessments wil be conducted at 1 month (end of taper), 3 and 6 months following completion of the acute phase. All assessments in the acute treatment phase and the taper phase will have a +/- 1 week collection window.

Enrollment

50 patients

Sex

All

Ages

18+ 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
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 criteria

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