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| Name | Class |
|---|---|
| Fisher Wallace | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator Device | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Systematic Assessment for Treatment Emergent Events (SAFTEE) at week 8 | assessment at week tolerability, safety and adherence at week 8 | Week 8 |
| Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 4 |
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Inclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProofPilot (Remote Virtual Trial) | New York | New York | 10003 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2020 | Sep 1, 2020 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 9, 2020 | Sep 1, 2020 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 29, 2022 | Aug 22, 2022 | 2 |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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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.
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This is a fully remote trial. Participants will be randomized in ProofPilot, and only the fulfillment center will know whether the participant is in the placebo or control arm.
Participants will be unblinded at week 4 at the crossover.
Change in self reported depression self assessed at baseline and week 4. Lower scores in the PHQ-8 show improvement in depression symptoms
| 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. | 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. | 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. | 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. | Week 2 |