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Unipolar DepressionPhase 1NCT04781127

Home-administered tDCS for Treatment of Depression

A Phase 1 study testing Soterix Medical mini-CT tDCS stimulator in people with Unipolar Depression and Treatment Resistant Depression, run by Soterix Medical at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 sessions of 30 minutes each will be delivered over 10 weeks. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Soterix Medical mini-CT tDCS stimulator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
10 Feb 2021to 10 Aug 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Subjects with an implanted pump, neurostimulator, cardiac pacemaker or defibrillator
  • Skin lesions on scalp at the proposed electrode sites
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York University

    New York, New York, 10011

Other trials in United States

About this study

Official title: An Open Label Home-administered Transcranial Direct Current Stimulation (tDCS) Clinical Trial of Unipolar 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.

Read the 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 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.

Being tested
Soterix Medical mini-CT tDCS stimulator
Keywords
tDCS
Medical subject headings
Depressive Disorder, Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Soterix Medical mini-CT tDCS stimulatorDevice

    Also called Soterix Medical ElectraRx, Soterix Medical SNAPpad

    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.

Study groups in NCT04781127
Study groupRoleWhat they receive
Active tDCSExperimentalActive Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator
Receives: Device: Soterix Medical mini-CT tDCS stimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Mood

    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.

    Measured: 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)

Secondary outcomes (7)

  1. Self-Reported Mood Score

    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.

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

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

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

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

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

    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)

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

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

    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.

    Measured: 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)

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

    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.

    Measured: Weeks 1-10

  6. Adverse Effects: Pain

    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).

    Measured: Weeks 1-10

  7. Adverse Effects: Suicidal Ideation

    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.")

    Measured: Weeks 1-10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2021
  2. Study start10 Feb 2021
  3. Primary completion10 Aug 2022
  4. Study completion10 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open Label
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04781127
Sponsor's protocol ID
SMI-F10
Status last verified
Jan 2023
First submitted
25 Feb 2021
Last updated
30 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Brunoni AR, Moffa AH, Sampaio-Junior B, Borrione L, Moreno ML, Fernandes RA, Veronezi BP, Nogueira BS, Aparicio LVM, Razza LB, Chamorro R, Tort LC, Fraguas R, Lotufo PA, Gattaz WF, Fregni F, Bensenor IM; ELECT-TDCS Investigators. Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression. N Engl J Med. 2017 Jun 29;376(26):2523-2533. doi: 10.1056/NEJMoa1612999.

    PubMed 28657871

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Soterix Medical mini-CT tDCS stimulator in people with Unipolar Depression and Treatment Resistant Depression, run by Soterix Medical at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04781127, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.

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