Major Depressive DisorderNCT04541563
Fisher Wallace Neurostimulation & Depression Study
A study testing Fisher Wallace Cranial Electrotherapy Stimulator Device in people with Major Depressive Disorder, run by ProofPilot at 1 site in United States.
Trial summary
Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device on Major Depressive Disorder using two 20-minute per day treatment sessions over eight weeks. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Fisher Wallace Cranial Electrotherapy Stimulator Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 21
- US resident
- Can receive packages to their home via UPS/Fedex/USPS
- Major Depressive Disorder
- PHQ-8 Score greater than 10 (show some signs of mild to moderate depression)
- PHQ-8 Score less than 20 (given remote study serious depressed should be excluded)
Show all 18Show fewer
- Read/write English
- have not contemplated suicide in the past year
- not been institutionalized for mental health issues.
- not currently experiencing problems with alcohol or drug abuse
- can commit to not drinking alcohol 4 hours before bedtime for the duration of the study
- can commit to two (2) 20 minute sessions per day for 8 weeks
- has not used a brain stimulation treatment in one year
- no suspected or known history of heart disease
- no pacemaker
- not under medical supervision for other serious medical condition
- not taking opioids
- is a resident of states in which we have licensed medical professionals
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
ProofPilot (Remote Virtual Trial)
New York, New York, 10003
About this study
Official title: Neurostimulation & Depression Study
Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device on Major Depressive Disorder using two 20-minute per day treatment sessions over eight weeks.
- Conditions
- Major Depressive Disorder
- Being tested
- Fisher Wallace Cranial Electrotherapy Stimulator Device
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fisher Wallace Cranial Electrotherapy Stimulator DeviceDevice
Fisher Wallace Stimulator®, a patented cranial electrotherapy stimulation device that was cleared by the FDA in 1991 for the treatment of depression, anxiety and insomnia.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment Arm | Experimental | The immediate treatment arm participants will be shipped an active Fisher Wallace device limited to Level 2 output even if a participant raises the dial beyond that. The participant will remain with the active device for the full 8 weeks. Receives: Device: Fisher Wallace Cranial Electrotherapy Stimulator Device |
| Delayed Treatment Arm | Sham comparator | In the delayed treatment arm, the participants will receive a sham device that looks exactly the same, but only provides treatment for 2 seconds. At week 4, sham arm participants will be unblinded and shipped an active device (limited to Level 2 output even if a participant raises the dial beyond that). The delayed arm participants will continue with active devices for the remaining 4 weeks of the trial. Receives: Device: Fisher Wallace Cranial Electrotherapy Stimulator Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Beck Depression Inventory Score Baseline vs week 4
Change in depression symptoms from baseline to treatment week 4 in immediate versus delayed arm. Lower scores show improvement in depression symptoms.
Measured: Week 4
Secondary outcomes (6)
Systematic Assessment for Treatment Emergent Events (SAFTEE) at week 8
assessment at week tolerability, safety and adherence at week 8
Measured: Week 8
Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 4
Change in self reported depression self assessed at baseline and week 4. Lower scores in the PHQ-8 show improvement in depression symptoms
Measured: Week 4
Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 2
Change in self reported depression self assessed at baseline and week 2. Lower scores in the PHQ-8 show improvement in depression symptoms.
Measured: Week 2
Change in Beck Depression Inventory Score Delay Arm Week 4 to Week 8
Participants will self assess at point of receiving active device at crossover for the remaining 4 weeks of the trial. Lower scores show improvement in depression symptoms.
Measured: Week 8
Change in Hamilton Depression Score Baseline vs week 4
Participants will be assessed by a tele-psychiatrist at baseline and week 4. Lower scores show improvement in depression symptoms.
Measured: Week 4
Change in Hamilton Depression Score Baseline vs week 2
Participants will be assessed by a tele-psychiatrist at baseline and week 2. Lower scores show improvement in depression symptoms.
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start24 Aug 2020
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a fully remote trial where participants engage at home in the study using the ProofPilot study platform. All potential participant enrollment data, including proof of identity via government ID will be reviewed by licensed medical professionals in the participant's state prior to their full enrollment. Participants will be randomized into an immediate or delayed treatment arm. The immediate treatment arm participants will be shipped an active Fisher Wallace device limited to Level 2 output even if a participant raises the dial beyond that. The participant will remain with the active device for the full 8 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProofPilot
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fisher Wallace
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541563
- Sponsor's protocol ID
- 2518
- Status last verified
- Feb 2021
- First submitted
- 14 Aug 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurostimulation & Depression Study
- ClinicalTrials.gov ID
- NCT04541563
- Acronym / sponsor ID
- 2518
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- ProofPilotIndustry (pharma, biotech, devices)
- Collaborators
- Fisher Wallace
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device on Major Depressive Disorder using two 20-minute per day treatment sessions over eight weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a fully remote trial where participants engage at home in the study using the ProofPilot study platform. All potential participant enrollment data, including proof of identity via government ID will be reviewed by licensed medical professionals in the participant's state prior to their full enrollment. Participants will be randomized into an immediate or delayed treatment arm. The immediate treatment arm participants will be shipped an active Fisher Wallace device limited to Level 2 output even if a participant raises the dial beyond that. The participant will remain with the active device for the full 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment Arm | Experimental | Device: Fisher Wallace Cranial Electrotherapy Stimulator DeviceThe immediate treatment arm participants will be shipped an active Fisher Wallace device limited to Level 2 output even if a participant raises the dial beyond that. The participant will remain with the active device for the full 8 weeks. |
| Delayed Treatment Arm | Sham comparator | Device: Fisher Wallace Cranial Electrotherapy Stimulator DeviceIn the delayed treatment arm, the participants will receive a sham device that looks exactly the same, but only provides treatment for 2 seconds. At week 4, sham arm participants will be unblinded and shipped an active device (limited to Level 2 output even if a participant raises the dial beyond that). The delayed arm participants will continue with active devices for the remaining 4 weeks of the trial. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age greater than or equal to 21
- US resident
- Can receive packages to their home via UPS/Fedex/USPS
- Major Depressive Disorder
- PHQ-8 Score greater than 10 (show some signs of mild to moderate depression)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator DeviceFisher Wallace Stimulator®, a patented cranial electrotherapy stimulation device that was cleared by the FDA in 1991 for the treatment of depression, anxiety and insomnia. | Device | Delayed Treatment Arm, Immediate Treatment Arm |
Primary outcome
Change in Beck Depression Inventory Score Baseline vs week 4
Time frame: Week 4
Change in depression symptoms from baseline to treatment week 4 in immediate versus delayed arm. Lower scores show improvement in depression symptoms.
6 secondary outcomes
Systematic Assessment for Treatment Emergent Events (SAFTEE) at week 8
Time frame: Week 8
Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 4
Time frame: Week 4
Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 2
Time frame: Week 2
Change in Beck Depression Inventory Score Delay Arm Week 4 to Week 8
Time frame: Week 8
Change in Hamilton Depression Score Baseline vs week 4
Time frame: Week 4
Change in Hamilton Depression Score Baseline vs week 2
Time frame: Week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fisher Wallace Cranial Electrotherapy Stimulator Device in people with Major Depressive Disorder, run by ProofPilot 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 18 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 Beck Depression Inventory Score Baseline vs week 4 (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2021.