| Primary | Change in the Beck Depression Inventory Second Edition (BDI-II) at Week Two Compared to Baseline. | The Beck Depression Inventory Second Edition (BDI-II) is a multiple-choice self-report inventory that assesses severity of depression. The BDI-II contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms. The candidate subject's BDI-II score must be within the range of 20 to 63 indicating moderate to severe Major Depressive Disorder. | Intent to Treat (ITT) population | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Change at week two compared to baseline. | | | | ID | Title | Description |
|---|
| OG000 | Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. Fisher Wallace Cranial Electrotherapy Stimulator (Active Device): The indicated use in adults (ages 21-65 years) is for 20 minutes twice daily, upon waking for the day and at bedtime. The treatment period of the intervention will have a duration of four weeks. | | OG001 | Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00016.65(14.691 to 18.610)
- OG00114.36(12.244 to 16.476)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Regression, Linear | | 0.056 | | | | | | | | | | | | | | Superiority | | |
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| Secondary | Change in the Beck Depression Inventory Second Edition (BDI-II) at Weeks One and Four Compared to Baseline. | The Beck Depression Inventory Second Edition (BDI-II) is a multiple-choice self-report inventory that assesses severity of depression. The BDI-II contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms. The candidate subject's BDI-II score must be within the range of 20 to 63 indicating moderate to severe Major Depressive Disorder. | Intent-to-treat (ITT) population | Posted | | Mean | Standard Deviation | units on a scale | | Change at weeks one and four compared to baseline. | | | | ID | Title | Description |
|---|
| OG000 | Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. Fisher Wallace Cranial Electrotherapy Stimulator (Active Device): The indicated use in adults (ages 21-65 years) is for 20 minutes twice daily, upon waking for the day and at bedtime. The treatment period of the intervention will have a duration of four weeks. | | OG001 | Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit. |
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| Secondary | Change in the Patient Health Questionnaire-9 (PHQ-9) at Weeks One, Two, and Four Compared to Baseline. | The Patient Health Questionnaire-9 (PHQ-9) is a 9-item scale covering the Diagnostic and Statistical Manual, 5th Edition (DSM-5) for Major Depressive Disorder, with a diagnostic algorithm and score-based assessment of presence and severity of depression. The minimum score is 0 and the maximum score is 27, with a higher score indicating more severe depressive symptoms. | Intent to Treat population | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Change at weeks one, two, and four compared to baseline. | | | | ID | Title | Description |
|---|
| OG000 | Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. Fisher Wallace Cranial Electrotherapy Stimulator (Active Device): The indicated use in adults (ages 21-65 years) is for 20 minutes twice daily, upon waking for the day and at bedtime. The treatment period of the intervention will have a duration of four weeks. | | OG001 | Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit. |
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| Secondary | Change in the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) at Weeks One, Two, and Four Compared to Baseline. | The Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) is a 16-item rating scale that assesses nine criterion symptom domains to diagnose a major depressive episode. The minimum score is 0 and the maximum score is 27, with a higher score indicating more severe depressive symptoms. | Intent to Treat population | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Change at weeks one, two, and four compared to baseline. | | | | ID | Title | Description |
|---|
| OG000 | Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. Fisher Wallace Cranial Electrotherapy Stimulator (Active Device): The indicated use in adults (ages 21-65 years) is for 20 minutes twice daily, upon waking for the day and at bedtime. The treatment period of the intervention will have a duration of four weeks. | | OG001 | Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit. |
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| Secondary | Beck Depression Inventory Second Edition (BDI-II) Responder Rate by Time Point (% of Subjects With a 50% or Better Improvement in Score From Baseline). | The Beck Depression Inventory Second Edition (BDI-II) is a multiple-choice self-report inventory that assesses severity of depression. The BDI-II contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms. The candidate subject's BDI-II score must be within the range of 20 to 63 indicating moderate to severe Major Depressive Disorder. | | Posted | | Count of Participants | | Participants | | Four weeks following baseline. | | | | ID | Title | Description |
|---|
| OG000 | Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. Fisher Wallace Cranial Electrotherapy Stimulator (Active Device): The indicated use in adults (ages 21-65 years) is for 20 minutes twice daily, upon waking for the day and at bedtime. The treatment period of the intervention will have a duration of four weeks. | | OG001 | Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit. |
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| Post-Hoc | Change in the Beck Depression Inventory Second Edition (BDI-II) at Weeks One and Four Compared to Baseline (Per Protocol). | The Beck Depression Inventory Second Edition (BDI-II) is a multiple-choice self-report inventory that assesses severity of depression. The BDI-II contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms. The candidate subject's BDI-II score must be within the range of 20 to 63 indicating moderate to severe Major Depressive Disorder. | | Posted | | Mean | Standard Deviation | units on a scale | | Change at weeks one and four compared to baseline. | | | | ID | Title | Description |
|---|
| OG000 | Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. Fisher Wallace Cranial Electrotherapy Stimulator (Active Device): The indicated use in adults (ages 21-65 years) is for 20 minutes twice daily, upon waking for the day and at bedtime. The treatment period of the intervention will have a duration of four weeks. | | OG001 | Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit. |
|
| Post-Hoc | Change in the Beck Depression Inventory Second Edition (BDI-II) at Week Two Compared to Baseline (Per Protocol). | The Beck Depression Inventory Second Edition (BDI-II) is a multiple-choice self-report inventory that assesses severity of depression. The BDI-II contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms. The candidate subject's BDI-II score must be within the range of 20 to 63 indicating moderate to severe Major Depressive Disorder. | Per protocol (PP) population | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Change at week two compared to baseline. | | | | ID | Title | Description |
|---|
| OG000 | Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. Fisher Wallace Cranial Electrotherapy Stimulator (Active Device): The indicated use in adults (ages 21-65 years) is for 20 minutes twice daily, upon waking for the day and at bedtime. The treatment period of the intervention will have a duration of four weeks. | | OG001 | Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit. |
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| Post-Hoc | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | The Beck Depression Inventory Second Edition (BDI-II) is a multiple-choice self-report inventory that assesses severity of depression. The BDI-II contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms. The candidate subject's BDI-II score must be within the range of 20 to 63 indicating moderate to severe Major Depressive Disorder. | Intent to Treat population (N = 255) | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Change at weeks 1, 2, and 4 compared to baseline | | | | ID | Title | Description |
|---|
| OG000 | Female (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. | | OG001 | Female (Placebo Device) | The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit. | | OG002 | Total (Female) | Total females across active and placebo arms |
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| Post-Hoc | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | The Beck Depression Inventory Second Edition (BDI-II) is a multiple-choice self-report inventory that assesses severity of depression. The BDI-II contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms. The candidate subject's BDI-II score must be within the range of 20 to 63 indicating moderate to severe Major Depressive Disorder. | | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Change at weeks 1, 2, and 4 compared to baseline | | | | ID | Title | Description |
|---|
| OG000 | Female (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. | | OG001 | Female (Placebo Device) | The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit. | | OG002 | Male (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. |
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| Post-Hoc | Change in PHQ-9 From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | The Patient Health Questionnaire-9 (PHQ-9) is a 9-item scale covering the Diagnostic and Statistical Manual, 5th Edition (DSM-5) for Major Depressive Disorder, with a diagnostic algorithm and score-based assessment of presence and severity of depression. The minimum score is 0 and the maximum score is 27, with a higher score indicating more severe depressive symptoms. | | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Change at weeks 1, 2, and 4 compared to baseline | | | | ID | Title | Description |
|---|
| OG000 | Female (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. | | OG001 | Female (Placebo Device) | The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit. | | OG002 | Male (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. |
|
| Post-Hoc | Change in QIDS From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | The Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) is a 16-item rating scale that assesses nine criterion symptom domains to diagnose a major depressive episode. The minimum score is 0 and the maximum score is 27, with a higher score indicating more severe depressive symptoms. | | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | Change at weeks 1, 2, and 4 compared to baseline | | | | ID | Title | Description |
|---|
| OG000 | Female (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. | | OG001 | Female (Placebo Device) | The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit. | | OG002 | Male (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. | | OG003 |
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| Post-Hoc | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses) | The Beck Depression Inventory Second Edition (BDI-II) is a multiple-choice self-report inventory that assesses severity of depression. The BDI-II contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms. The candidate subject's BDI-II score must be within the range of 20 to 63 indicating moderate to severe Major Depressive Disorder. | | Posted | | Count of Participants | | Participants | | Weeks 1, 2, and 4 following baseline | | | | ID | Title | Description |
|---|
| OG000 | Female (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. | | OG001 | Female (Placebo Device) | The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit. | | OG002 | Male (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. |
|
| Post-Hoc | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | The Beck Depression Inventory Second Edition (BDI-II) is a multiple-choice self-report inventory that assesses severity of depression. The BDI-II contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms. The candidate subject's BDI-II score must be within the range of 20 to 63 indicating moderate to severe Major Depressive Disorder. | | Posted | | Count of Participants | | Participants | | Weeks 1, 2, and 4 following baseline | | | | ID | Title | Description |
|---|
| OG000 | Female (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. | | OG001 | Female (Placebo Device) | The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit. | | OG002 | Male (Active Device) | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. |
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