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Completed

NCT Number: NCT04781127

Home-administered tDCS for Treatment of Depression

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.

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Key information

Conditions

Unipolar Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders Treatment Resistant Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New York University

New York, 10011, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soterix Medical mini-CT tDCS stimulator

Device

Stimulation will last 30 minutes per day, 5 days per week, for 5 weeks, then 3 days per week for 1 week and then 1 day per week for 4 weeks.

Other names: Soterix Medical ElectraRx, Soterix Medical SNAPpad

Primary outcomes

  1. Change in Mood

    Time frame: Baseline, at the end of Weeks 2, 4 ,6 during the acute phase, at completion of taper phase (end of Week 10) and during the Follow-up period (end of Weeks 18 and 30)

    Mood will be assessed with the Montgomery Asberg Depression Rating Scale (MADRS). 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.

Secondary outcomes

  1. Self-Reported Mood Score

    Time frame: Weeks 1-10. Patients who receive maintenance sessions will also report before sessions 33-46 (Weeks 11-30)

    Patients will enter daily mood scores before each treatment session on a scale of 0-10 (0= feeling normal and not depressed at all and 10= feeling as depressed as possible) on the web interface.

  2. Quick Inventory of Depressive Symptomology (QIDS-SR)

    Time frame: Weeks 1-10. Patients who receive maintenance sessions will also report at the end of Weeks 11-18, 20, 22, 24, 26, 28, 30

    Patients will enter responses at the end of each week on the web interface. (16 question survey with higher score for more severe symptoms)

  3. Quality of Life Enjoyment and Satisfaction Questionnaire Form (Q-LES-Q-SF)

    Time frame: Weeks 1-10. Patients who receive maintenance sessions will also report at the end of Weeks 11-18, 20, 22, 24, 26, 28, 30

    Patients will enter responses at the end of each week on the web interface. (16 question survey with answers between 1-5 where higher score represents better outcomes)

  4. Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Baseline, at the end of Weeks 2, 4 ,6 during the acute phase, at completion of taper phase (end of Week 10) and during the Follow-up period (end of Weeks 18 and 30)

    Patients will respond to questions about suicidal ideation and behavior, where "yes" or "no" answers indicate level of risk (low, moderate or high). More "yes" answers indicate worse outcomes.

  5. Self-report Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Weeks 1-10

    Patients will enter scores before each treatment session on the web interface about suicidal ideation and behavior, where "yes" or "no" answers indicate level of risk (low, moderate or high). More "yes" answers indicate worse outcomes.

  6. Adverse Effects: Pain

    Time frame: Weeks 1-10

    Participants will enter any side effects experienced, their severity (mild, moderate, severe), pain scores based on the Wong-Baker pain scale and temporal relationship with the tDCS session (before, during, after).

  7. Adverse Effects: Suicidal Ideation

    Time frame: Weeks 1-10

    Participants will enter a score using item 9 of the Beck Depression Inventory (range from 0 = "I don't have any thoughts of killing myself." to 3 = "I would kill myself if I had the chance.")

Sponsors and collaborators

Lead sponsor

Soterix Medical

Industry

Collaborators

  • NYU Langone Health

Registry information

Official study title

An Open Label Home-administered Transcranial Direct Current Stimulation (tDCS) Clinical Trial of Unipolar Depression

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2021
Registry last updated
Jan 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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