Major Depressive Disorder
Conditions
Keywords
MDD, Depression, Depressive Disorder, Major Depressive Disorder, Cranial Electrotherapy Stimulation, FW-200
Brief summary
This study is designed to evaluate the safety and efficacy of the Fisher Wallace Stimulator FW-200 to deliver Cranial Electrotherapy Stimulation (CES) for the treatment of moderate to severe Major Depressive Disorder (MDD) in adults.
Detailed description
This prospective, fully remote, randomized, controlled, triple-blind (subject, Principal Investigator, Sponsor) pivotal study is designed to evaluate the safety and efficacy of the Fisher Wallace Stimulator FW-200 to deliver Cranial Electrotherapy Stimulation (CES) for the treatment of moderate to severe Major Depressive Disorder (MDD) in adults.
Interventions
DEVICEFisher 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.
DEVICEFisher 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.
Sponsors
NAMSA
Climb Technologies, Inc.
Fisher Wallace Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Remote, randomized, decentralized, controlled, triple-blind (subject, Principal Investigator, Sponsor) pivotal investigation.
Intervention model description
Pivotal Study
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 21-65 years and a resident of the United States of America 2. Meets DSM-5 diagnostic criteria for moderate to severe Major Depressive Disorder 3. Baseline BDI-II score between 20 and 63, inclusive (in moderate to severe range) 4. Able to receive packages to their home via United Parcel Service/Fedex/United States Postal Service or other delivery service 5. Willing and able to send and receive study related text messages on an internet capable mobile device throughout the duration of the study 6. Owns and uses a personal, verifiable email address 7. Able to commit to two (2) 20-minute treatment sessions per day for 4 weeks, one treatment upon waking for the day and one treatment before going to bed 8. Willing to abstain from use of recreational drugs, hypnotics, steroids, and/or marijuana products through study completion 9. Willingness to not initiate treatment for a mental health issue during the course of the study 10. Fluent in English 11. Sexually active females of childbearing potential willing to commit to practicing at least one or more of the following methods of contraception during the study: intrauterine device (IUD), barrier method in combination with a spermicide, oral/hormonal contraception, or abstinence 12. In the opinion of the investigator, able to comply with study requirements and complete the study
Exclusion criteria
1. History of suicide attempt or active suicidal ideation with plan or intent in the past 30 days. 2. In the opinion of the investigator, considered high risk of suicide 3. Previous hospitalization or institutionalization for mental health condition within one year of study entry 4. Underwent electronic brain stimulation or neuromodulation within the past one year, including CES, transcranial magnetic stimulation, electroconvulsive therapy, and deep brain stimulation 5. Modification of prescription medications that affect the nervous system (e.g., psychotropic medications) within 30 days of study entry 6. Use of recreational drugs, hypnotics, steroids, and/or marijuana products in the past 30 days 7. History of alcohol use disorder or other substance use disorder in the past 12 months 8. Females currently pregnant or planning to conceive during study participation, or unwilling to comply with birth control requirements 9. Known history of heart disease 10. Known history of trigeminal neuralgia 11. Implanted with an electronic device such as a defibrillator, deep brain stimulator, or pacemaker 12. Unstable medical condition including any condition requiring hospitalization or change in treatment in the prior 30 days 13. Legally blind and/or deaf and without in-home care service to assist with study participation 14. Meets M.I.N.I. assessment criteria for, or has been diagnosed with, any of the following: Bipolar I disorder, bipolar II disorder, other specified bipolar and related disorder, panic disorder, agoraphobia, social anxiety disorder (social phobia), obsessive-compulsive disorder, posttraumatic stress disorder, alcohol use disorder in the past 12 months, substance use disorder (non-alcohol) in the past 12 months, any psychotic disorder (e.g., schizophrenia, schizoaffective disorder), major depressive disorder with psychotic features, anorexia nervosa, bulimia nervosa, binge-eating disorder, generalized anxiety disorder, any cognitive or developmental disorder (e.g., autism, Down's Syndrome), any personality disorder or psychiatric disorder that may interfere with study participation 15. Current participation in another investigational study or participated in an investigational study within the past 30 days 16. In the opinion of the investigator, may not be able to comply with study requirements 17. Any employee, family member, or personal associate of the Sponsor or their designees conducting the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Beck Depression Inventory Second Edition (BDI-II) at Week Two Compared to Baseline. | Change 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Beck Depression Inventory Second Edition (BDI-II) at Weeks One and Four Compared to Baseline. | Change 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. |
| Change in the Patient Health Questionnaire-9 (PHQ-9) at Weeks One, Two, and Four Compared to Baseline. | Change 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. |
| Change in the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) at Weeks One, Two, and Four Compared to Baseline. | Change 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. |
| Beck Depression Inventory Second Edition (BDI-II) Responder Rate by Time Point (% of Subjects With a 50% or Better Improvement in Score From Baseline). | Four weeks following 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 126 |
| 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.
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. | 129 |
| Total | 255 |
Baseline characteristics
| Characteristic | Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Total |
|---|---|---|---|
| Age, Continuous | 39.6 years STANDARD_DEVIATION 10.04 | 40.1 years STANDARD_DEVIATION 10.9 | 39.8 years STANDARD_DEVIATION 10.47 |
| Baseline Clinical Characteristics Beck Depression Inventory-II (BDI-II) | 33 units on a scale | 33.9 units on a scale STANDARD_DEVIATION 8.99 | 34.0 units on a scale STANDARD_DEVIATION 8.92 |
| Baseline Clinical Characteristics Personal Health Questionnaire Depression Scale (PHQ-9) | 16.0 units on a scale STANDARD_DEVIATION 4.76 | 16 units on a scale | 16 units on a scale |
| Baseline Clinical Characteristics Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) | 16.0 units on a scale STANDARD_DEVIATION 3.91 | 16 units on a scale | 16.0 units on a scale STANDARD_DEVIATION 3.78 |
| Beck Depression Inventory-II (BDI-II) clinically based categories Mild (scores 14-19) | 0 Participants | 0 Participants | 0 Participants |
| Beck Depression Inventory-II (BDI-II) clinically based categories Minimal (scores 0-13) | 0 Participants | 0 Participants | 0 Participants |
| Beck Depression Inventory-II (BDI-II) clinically based categories Moderate (scores 20-28) | 44 Participants | 39 Participants | 83 Participants |
| Beck Depression Inventory-II (BDI-II) clinically based categories Severe (scores 29-63) | 82 Participants | 90 Participants | 172 Participants |
| BMI | 20.5 kg/m^2 STANDARD_DEVIATION 5.1 | 20.7 kg/m^2 STANDARD_DEVIATION 5.6 | 20.6 kg/m^2 STANDARD_DEVIATION 5.4 |
| Race/Ethnicity, Customized Asian | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 7 Participants | 16 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 9 Participants | 7 Participants | 16 Participants |
| Race/Ethnicity, Customized Other | 12 Participants | 11 Participants | 23 Participants |
| Race/Ethnicity, Customized White | 92 Participants | 99 Participants | 191 Participants |
| Region of Enrollment United States | 126 participants | 129 participants | 255 participants |
| Sex: Female, Male Female | 96 Participants | 89 Participants | 185 Participants |
| Sex: Female, Male Male | 30 Participants | 40 Participants | 70 Participants |
| Use of concurrent anti-depressant medication | 55 Participants | 47 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 126 | 0 / 129 |
| other Total, other adverse events | 19 / 126 | 10 / 129 |
| serious Total, serious adverse events | 0 / 126 | 0 / 129 |
Outcome results
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.
Time frame: Change at week two compared to baseline.
Population: Intent to Treat (ITT) population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in the Beck Depression Inventory Second Edition (BDI-II) at Week Two Compared to Baseline. | 16.65 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in the Beck Depression Inventory Second Edition (BDI-II) at Week Two Compared to Baseline. | 14.36 units on a scale |
Comparison: Intent to Treat analysesp-value: 0.056Regression, Linear
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.
Time frame: Four weeks following baseline.
Population: Intent-to-treat analysis
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Beck Depression Inventory Second Edition (BDI-II) Responder Rate by Time Point (% of Subjects With a 50% or Better Improvement in Score From Baseline). | Week 1 Response | Yes | 46 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Beck Depression Inventory Second Edition (BDI-II) Responder Rate by Time Point (% of Subjects With a 50% or Better Improvement in Score From Baseline). | Week 1 Response | No | 80 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Beck Depression Inventory Second Edition (BDI-II) Responder Rate by Time Point (% of Subjects With a 50% or Better Improvement in Score From Baseline). | Week 2 Response | Yes | 64 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Beck Depression Inventory Second Edition (BDI-II) Responder Rate by Time Point (% of Subjects With a 50% or Better Improvement in Score From Baseline). | Week 2 Response | No | 62 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Beck Depression Inventory Second Edition (BDI-II) Responder Rate by Time Point (% of Subjects With a 50% or Better Improvement in Score From Baseline). | Week 4 Response | Yes | 82 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Beck Depression Inventory Second Edition (BDI-II) Responder Rate by Time Point (% of Subjects With a 50% or Better Improvement in Score From Baseline). | Week 4 Response | No | 44 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Beck Depression Inventory Second Edition (BDI-II) Responder Rate by Time Point (% of Subjects With a 50% or Better Improvement in Score From Baseline). | Week 4 Response | Yes | 68 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Beck Depression Inventory Second Edition (BDI-II) Responder Rate by Time Point (% of Subjects With a 50% or Better Improvement in Score From Baseline). | Week 1 Response | Yes | 38 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Beck Depression Inventory Second Edition (BDI-II) Responder Rate by Time Point (% of Subjects With a 50% or Better Improvement in Score From Baseline). | Week 2 Response | No | 74 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Beck Depression Inventory Second Edition (BDI-II) Responder Rate by Time Point (% of Subjects With a 50% or Better Improvement in Score From Baseline). | Week 1 Response | No | 91 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Beck Depression Inventory Second Edition (BDI-II) Responder Rate by Time Point (% of Subjects With a 50% or Better Improvement in Score From Baseline). | Week 4 Response | No | 61 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Beck Depression Inventory Second Edition (BDI-II) Responder Rate by Time Point (% of Subjects With a 50% or Better Improvement in Score From Baseline). | Week 2 Response | Yes | 55 Participants |
Comparison: Difference (Active-Control) at Week 1p-value: 0.231Chi-squared
Comparison: Difference (Active-Control) at Week 2p-value: 0.192Chi-squared
Comparison: Difference (Active-Control) at Week 4p-value: 0.045Chi-squared
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.
Time frame: Change at weeks one and four compared to baseline.
Population: Intent-to-treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in the Beck Depression Inventory Second Edition (BDI-II) at Weeks One and Four Compared to Baseline. | Change in BDI-II at Week 1 (ITT analysis) | 14.1 units on a scale | Standard Deviation 9.93 |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in the Beck Depression Inventory Second Edition (BDI-II) at Weeks One and Four Compared to Baseline. | Change in BDI-II at Week 4 (ITT analysis) | 19.9 units on a scale | Standard Deviation 11.91 |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in the Beck Depression Inventory Second Edition (BDI-II) at Weeks One and Four Compared to Baseline. | Change in BDI-II at Week 1 (ITT analysis) | 11.5 units on a scale | Standard Deviation 10.68 |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in the Beck Depression Inventory Second Edition (BDI-II) at Weeks One and Four Compared to Baseline. | Change in BDI-II at Week 4 (ITT analysis) | 16.9 units on a scale | Standard Deviation 12.46 |
Comparison: Difference (Active - Control) at Week 1p-value: 0.048t-test, 2 sided
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.
Time frame: Change at weeks one, two, and four compared to baseline.
Population: Intent to Treat population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in the Patient Health Questionnaire-9 (PHQ-9) at Weeks One, Two, and Four Compared to Baseline. | Change in PHQ-9 at Week 1 | 5.27 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in the Patient Health Questionnaire-9 (PHQ-9) at Weeks One, Two, and Four Compared to Baseline. | Change in PHQ-9 at Week 2 | 7.46 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in the Patient Health Questionnaire-9 (PHQ-9) at Weeks One, Two, and Four Compared to Baseline. | Change in PHQ-9 at Week 4 | 8.88 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in the Patient Health Questionnaire-9 (PHQ-9) at Weeks One, Two, and Four Compared to Baseline. | Change in PHQ-9 at Week 1 | 4.50 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in the Patient Health Questionnaire-9 (PHQ-9) at Weeks One, Two, and Four Compared to Baseline. | Change in PHQ-9 at Week 2 | 6.29 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in the Patient Health Questionnaire-9 (PHQ-9) at Weeks One, Two, and Four Compared to Baseline. | Change in PHQ-9 at Week 4 | 7.72 units on a scale |
Comparison: Difference (Active-Control) at Week 1p-value: 0.2595t-test, 2 sided
Comparison: Difference (Active-Control) at Week 2p-value: 0.1286t-test, 2 sided
Comparison: Difference (Active-Control) at Week 4p-value: 0.1449t-test, 2 sided
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.
Time frame: Change at weeks one, two, and four compared to baseline.
Population: Intent to Treat population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) at Weeks One, Two, and Four Compared to Baseline. | Change in QIDS-SR at Week 1 | 5.53 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) at Weeks One, Two, and Four Compared to Baseline. | Change in QIDS-SR at Week 2 | 6.72 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) at Weeks One, Two, and Four Compared to Baseline. | Change in QIDS-SR at Week 4 | 7.99 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) at Weeks One, Two, and Four Compared to Baseline. | Change in QIDS-SR at Week 1 | 4.77 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) at Weeks One, Two, and Four Compared to Baseline. | Change in QIDS-SR at Week 2 | 5.71 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) at Weeks One, Two, and Four Compared to Baseline. | Change in QIDS-SR at Week 4 | 6.90 units on a scale |
Comparison: Difference (Active-Control) at Week 1p-value: 0.2065t-test, 2 sided
Comparison: Difference (Active-Control) at Week 2p-value: 0.1349t-test, 2 sided
Comparison: Difference (Active-Control) at Week 4p-value: 0.1142t-test, 2 sided
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.
Time frame: Change at weeks 1, 2, and 4 compared to baseline
Population: Intent to Treat population (N = 255)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 2 | 17.9 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 1 | 15 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 4 | 21.2 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 1 | 10.6 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 2 | 14.2 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 4 | 17.1 units on a scale |
| Total (Female) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 1 | 12.9 units on a scale |
| Total (Female) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 4 | 19.2 units on a scale |
| Total (Female) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 2 | 16.1 units on a scale |
| Male (Active Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 2 | 12.6 units on a scale |
| Male (Active Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 4 | 15.6 units on a scale |
| Male (Active Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 1 | 11.5 units on a scale |
| Male (Placebo Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 1 | 13.6 units on a scale |
| Male (Placebo Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 2 | 14.8 units on a scale |
| Male (Placebo Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 4 | 16.5 units on a scale |
| Total (Males) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 4 | 16.1 units on a scale |
| Total (Males) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 1 | 12.7 units on a scale |
| Total (Males) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis) | Week 2 | 13.9 units on a scale |
Comparison: Difference (Active-Control) at Week 1p-value: 0.0026Regression, Linear
Comparison: Difference (Active-Control) at Week 1p-value: 0.4706Regression, Linear
Comparison: Difference (Active-Control) at Week 2p-value: 0.0197Regression, Linear
Comparison: Difference (Active-Control) at Week 2p-value: 0.4858Regression, Linear
Comparison: Difference (Active-Control) at Week 4p-value: 0.0183Regression, Linear
Comparison: Difference (Active-Control) at Week 4p-value: 0.7885Regression, Linear
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.
Time frame: Change at weeks 1, 2, and 4 compared to baseline
Population: Per protocol population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 1 | -15.22 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 4 | -21.53 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 2 | -18.23 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 1 | -9.79 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 4 | -17.04 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 2 | -13.76 units on a scale |
| Total (Female) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 2 | -15.53 units on a scale |
| Total (Female) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 1 | -14.27 units on a scale |
| Total (Female) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 4 | -17.92 units on a scale |
| Male (Active Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 1 | -12.47 units on a scale |
| Male (Active Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 4 | -15.25 units on a scale |
| Male (Active Device) | Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 2 | -13.49 units on a scale |
Comparison: Difference (Active-Control) at Week 1p-value: <0.001Regression, Linear
Comparison: Difference (Active-Control) at Week 1p-value: 0.45Regression, Linear
Comparison: Difference (Active-Control) at Week 2p-value: 0.008Regression, Linear
Comparison: Difference (Active-Control) at Week 2p-value: 0.438Regression, Linear
Comparison: Difference (Active-Control) at Week 4p-value: 0.016Regression, Linear
Comparison: Difference (Active-Control) at Week 4p-value: 0.355Regression, Linear
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.
Time frame: Change at weeks 1, 2, and 4 compared to baseline
Population: Per protocol population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in PHQ-9 From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 1 | -5.42 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in PHQ-9 From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 4 | -9.48 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in PHQ-9 From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 2 | -7.84 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in PHQ-9 From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 1 | -3.82 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in PHQ-9 From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 4 | -8.32 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in PHQ-9 From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 2 | -6.12 units on a scale |
| Total (Female) | Change in PHQ-9 From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 2 | -8.00 units on a scale |
| Total (Female) | Change in PHQ-9 From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 1 | -6.13 units on a scale |
| Total (Female) | Change in PHQ-9 From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 4 | -8.80 units on a scale |
| Male (Active Device) | Change in PHQ-9 From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 1 | -4.97 units on a scale |
| Male (Active Device) | Change in PHQ-9 From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 4 | -6.77 units on a scale |
| Male (Active Device) | Change in PHQ-9 From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 2 | -5.85 units on a scale |
Comparison: Difference (Active-Control) at Week 1p-value: 0.046Regression, Linear
Comparison: Difference (Active-Control) at Week 1p-value: 0.351Regression, Linear
Comparison: Difference (Active-Control) at Week 2p-value: 0.053Regression, Linear
Comparison: Difference (Active-Control) at Week 2p-value: 0.12Regression, Linear
Comparison: Difference (Active-Control) at Week 4p-value: 0.17Regression, Linear
Comparison: Difference (Active-Control) at Week 4p-value: 0.122Regression, Linear
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.
Time frame: Change at weeks 1, 2, and 4 compared to baseline
Population: Per protocol population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in QIDS From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 1 | -5.79 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in QIDS From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 4 | -8.53 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in QIDS From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 2 | -7.46 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in QIDS From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 1 | -4.33 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in QIDS From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 4 | -7.45 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in QIDS From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 2 | -5.52 units on a scale |
| Total (Female) | Change in QIDS From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 2 | -6.52 units on a scale |
| Total (Female) | Change in QIDS From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 1 | -5.91 units on a scale |
| Total (Female) | Change in QIDS From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 4 | -8.21 units on a scale |
| Male (Active Device) | Change in QIDS From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 1 | -5.55 units on a scale |
| Male (Active Device) | Change in QIDS From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 4 | -6.40 units on a scale |
| Male (Active Device) | Change in QIDS From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis) | Week 2 | -5.31 units on a scale |
Comparison: Difference (Active-Control) at Week 4p-value: 0.173Regression, Linear
Comparison: Difference (Active-Control) at Week 1p-value: 0.044Regression, Linear
Comparison: Difference (Active-Control) at Week 1p-value: 0.751Regression, Linear
Comparison: Difference (Active-Control) at Week 2p-value: 0.013Regression, Linear
Comparison: Difference (Active-Control) at Week 2p-value: 0.318Regression, Linear
Comparison: Difference (Active-Control) at Week 4p-value: 0.142Regression, Linear
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.
Time frame: Change at weeks one and four compared to baseline.
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in the Beck Depression Inventory Second Edition (BDI-II) at Weeks One and Four Compared to Baseline (Per Protocol). | Change in BDI-II at Week 1 (Per protocol analysis) | 14.4 units on a scale | Standard Deviation 10.14 |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in the Beck Depression Inventory Second Edition (BDI-II) at Weeks One and Four Compared to Baseline (Per Protocol). | Change in BDI-II at Week 4 (Per protocol analysis) | 20.0 units on a scale | Standard Deviation 11.87 |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in the Beck Depression Inventory Second Edition (BDI-II) at Weeks One and Four Compared to Baseline (Per Protocol). | Change in BDI-II at Week 1 (Per protocol analysis) | 11.3 units on a scale | Standard Deviation 10.09 |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in the Beck Depression Inventory Second Edition (BDI-II) at Weeks One and Four Compared to Baseline (Per Protocol). | Change in BDI-II at Week 4 (Per protocol analysis) | 16.5 units on a scale | Standard Deviation 12.47 |
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.
Time frame: Change at week two compared to baseline.
Population: Per protocol (PP) population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Change in the Beck Depression Inventory Second Edition (BDI-II) at Week Two Compared to Baseline (Per Protocol). | 17.15 units on a scale |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Change in the Beck Depression Inventory Second Edition (BDI-II) at Week Two Compared to Baseline (Per Protocol). | 13.62 units on a scale |
p-value: 0.005Regression, Linear
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.
Time frame: Weeks 1, 2, and 4 following baseline
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses) | Week 1 | 37 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses) | Week 4 | 68 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses) | Week 2 | 52 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses) | Week 1 | 20 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses) | Week 4 | 47 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses) | Week 2 | 35 Participants |
| Total (Female) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses) | Week 2 | 12 Participants |
| Total (Female) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses) | Week 1 | 9 Participants |
| Total (Female) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses) | Week 4 | 14 Participants |
| Male (Active Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses) | Week 1 | 18 Participants |
| Male (Active Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses) | Week 4 | 21 Participants |
| Male (Active Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses) | Week 2 | 20 Participants |
Comparison: Difference (Active-Control) at Week 1p-value: 0.026Chi-squared
Comparison: Difference (Active-Control) at Week 1p-value: 0.241Chi-squared
Comparison: Difference (Active-Control) at Week 2p-value: 0.059Chi-squared
Comparison: Difference (Active-Control) at Week 2p-value: 0.478Chi-squared
Comparison: Difference (Active-Control) at Week 4p-value: 0.009Chi-squared
Comparison: Difference (Active-Control) at Week 4p-value: 0.729Chi-squared
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.
Time frame: Weeks 1, 2, and 4 following baseline
Population: Per protocol population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 2 | 41 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 1 | 30 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 4 | 56 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 2 | 24 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 1 | 12 Participants |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 4 | 36 Participants |
| Total (Female) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 2 | 11 Participants |
| Total (Female) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 1 | 9 Participants |
| Total (Female) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 4 | 12 Participants |
| Male (Active Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 2 | 17 Participants |
| Male (Active Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 1 | 15 Participants |
| Male (Active Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 4 | 18 Participants |
| Male (Placebo Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 2 | 52 Participants |
| Male (Placebo Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 1 | 39 Participants |
| Male (Placebo Device) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 4 | 68 Participants |
| Total (Males) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 1 | 27 Participants |
| Total (Males) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 4 | 54 Participants |
| Total (Males) | Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses) | Week 2 | 41 Participants |
Comparison: Difference (Active-Control) at Week 1p-value: 0.044Chi-squared
Comparison: Difference (Active-Control) at Week 2p-value: 0.067Chi-squared
Comparison: Difference (Active-Control) at Week 4p-value: 0.016Chi-squared
Comparison: Difference (Active-Control) at Week 1p-value: 0.006Chi-squared
Comparison: Difference (Active-Control) at Week 2p-value: 0.036Chi-squared
Comparison: Difference (Active-Control) at Week 4p-value: 0.016Chi-squared
Comparison: Difference (Active-Control) at Week 1p-value: 0.914Chi-squared
Comparison: Difference (Active-Control) at Week 2p-value: 0.887Chi-squared
Comparison: Difference (Active-Control) at Week 4p-value: 0.791Chi-squared