Trial Outcomes & Findings for Cranial Electrotherapy Stimulation for the Treatment of Major Depressive Disorder in Adults (NCT NCT05384041)
NCT ID: NCT05384041
Last Updated: 2024-03-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
255 participants
Primary outcome timeframe
Change at week two compared to baseline.
Results posted on
2024-03-12
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
129
|
|
Overall Study
COMPLETED
|
121
|
125
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cranial Electrotherapy Stimulation for the Treatment of Major Depressive Disorder in Adults
Baseline characteristics by cohort
| Measure |
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
n=129 Participants
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.
|
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
n=126 Participants
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.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 10.90 • n=107 Participants
|
39.6 years
STANDARD_DEVIATION 10.04 • n=99 Participants
|
39.8 years
STANDARD_DEVIATION 10.47 • n=206 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=107 Participants
|
96 Participants
n=99 Participants
|
185 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=107 Participants
|
30 Participants
n=99 Participants
|
70 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
99 Participants
n=107 Participants
|
92 Participants
n=99 Participants
|
191 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=107 Participants
|
4 Participants
n=99 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=107 Participants
|
9 Participants
n=99 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
7 Participants
n=107 Participants
|
9 Participants
n=99 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=107 Participants
|
12 Participants
n=99 Participants
|
23 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
129 participants
n=107 Participants
|
126 participants
n=99 Participants
|
255 participants
n=206 Participants
|
|
BMI
|
20.7 kg/m^2
STANDARD_DEVIATION 5.6 • n=107 Participants
|
20.5 kg/m^2
STANDARD_DEVIATION 5.1 • n=99 Participants
|
20.6 kg/m^2
STANDARD_DEVIATION 5.4 • n=206 Participants
|
|
Baseline Clinical Characteristics
Beck Depression Inventory-II (BDI-II)
|
33 units on a scale
n=107 Participants
|
33 units on a scale
n=99 Participants
|
33 units on a scale
n=206 Participants
|
|
Baseline Clinical Characteristics
Personal Health Questionnaire Depression Scale (PHQ-9)
|
16 units on a scale
n=107 Participants
|
16 units on a scale
n=99 Participants
|
16 units on a scale
n=206 Participants
|
|
Baseline Clinical Characteristics
Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR)
|
16 units on a scale
n=107 Participants
|
16 units on a scale
n=99 Participants
|
16 units on a scale
n=206 Participants
|
|
Beck Depression Inventory-II (BDI-II) clinically based categories
Minimal (scores 0-13)
|
0 Participants
n=107 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=206 Participants
|
|
Beck Depression Inventory-II (BDI-II) clinically based categories
Mild (scores 14-19)
|
0 Participants
n=107 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=206 Participants
|
|
Beck Depression Inventory-II (BDI-II) clinically based categories
Moderate (scores 20-28)
|
39 Participants
n=107 Participants
|
44 Participants
n=99 Participants
|
83 Participants
n=206 Participants
|
|
Beck Depression Inventory-II (BDI-II) clinically based categories
Severe (scores 29-63)
|
90 Participants
n=107 Participants
|
82 Participants
n=99 Participants
|
172 Participants
n=206 Participants
|
|
Use of concurrent anti-depressant medication
|
47 Participants
n=107 Participants
|
55 Participants
n=99 Participants
|
102 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change at week two compared to baseline.Population: Intent to Treat (ITT) population
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.
Outcome measures
| Measure |
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
n=126 Participants
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.
|
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
n=129 Participants
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.
|
Total (Female)
Total females across active and placebo arms
|
Male (Active Device)
The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device.
|
Male (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.
|
Total (Males)
Total males across active and placebo arms
|
|---|---|---|---|---|---|---|
|
Change in the Beck Depression Inventory Second Edition (BDI-II) at Week Two Compared to Baseline.
|
16.65 units on a scale
Interval 14.691 to 18.61
|
14.36 units on a scale
Interval 12.244 to 16.476
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Change at weeks one and four compared to baseline.Population: Intent-to-treat (ITT) population
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.
Outcome measures
| Measure |
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
n=126 Participants
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.
|
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
n=129 Participants
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.
|
Total (Female)
Total females across active and placebo arms
|
Male (Active Device)
The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device.
|
Male (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.
|
Total (Males)
Total males across active and placebo arms
|
|---|---|---|---|---|---|---|
|
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
|
11.5 units on a scale
Standard Deviation 10.68
|
—
|
—
|
—
|
—
|
|
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
|
16.9 units on a scale
Standard Deviation 12.46
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Change at weeks one, two, and four compared to baseline.Population: Intent to Treat population
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.
Outcome measures
| Measure |
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
n=126 Participants
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.
|
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
n=129 Participants
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.
|
Total (Female)
Total females across active and placebo arms
|
Male (Active Device)
The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device.
|
Male (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.
|
Total (Males)
Total males across active and placebo arms
|
|---|---|---|---|---|---|---|
|
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
Interval 4.338 to 6.211
|
4.50 units on a scale
Interval 3.533 to 5.475
|
—
|
—
|
—
|
—
|
|
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
Interval 7.823 to 9.946
|
7.72 units on a scale
Interval 6.559 to 8.881
|
—
|
—
|
—
|
—
|
|
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
Interval 6.457 to 8.47
|
6.29 units on a scale
Interval 5.144 to 7.432
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Change at weeks one, two, and four compared to baseline.Population: Intent to Treat population
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.
Outcome measures
| Measure |
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
n=126 Participants
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.
|
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
n=129 Participants
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.
|
Total (Female)
Total females across active and placebo arms
|
Male (Active Device)
The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device.
|
Male (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.
|
Total (Males)
Total males across active and placebo arms
|
|---|---|---|---|---|---|---|
|
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
Interval 4.688 to 6.377
|
4.77 units on a scale
Interval 3.923 to 5.613
|
—
|
—
|
—
|
—
|
|
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
Interval 5.842 to 7.589
|
5.71 units on a scale
Interval 4.719 to 6.705
|
—
|
—
|
—
|
—
|
|
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
Interval 7.038 to 8.946
|
6.90 units on a scale
Interval 5.938 to 7.87
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Four weeks following baseline.Population: Intent-to-treat 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.
Outcome measures
| Measure |
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
n=126 Participants
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.
|
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
n=129 Participants
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.
|
Total (Female)
Total females across active and placebo arms
|
Male (Active Device)
The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device.
|
Male (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.
|
Total (Males)
Total males across active and placebo arms
|
|---|---|---|---|---|---|---|
|
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
|
38 Participants
|
—
|
—
|
—
|
—
|
|
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
|
91 Participants
|
—
|
—
|
—
|
—
|
|
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
|
55 Participants
|
—
|
—
|
—
|
—
|
|
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
|
74 Participants
|
—
|
—
|
—
|
—
|
|
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
|
68 Participants
|
—
|
—
|
—
|
—
|
|
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
|
61 Participants
|
—
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: Change at weeks one and four compared to baseline.Population: Per protocol population
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.
Outcome measures
| Measure |
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
n=126 Participants
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.
|
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
n=129 Participants
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.
|
Total (Female)
Total females across active and placebo arms
|
Male (Active Device)
The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device.
|
Male (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.
|
Total (Males)
Total males across active and placebo arms
|
|---|---|---|---|---|---|---|
|
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
|
11.3 units on a scale
Standard Deviation 10.09
|
—
|
—
|
—
|
—
|
|
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
|
16.5 units on a scale
Standard Deviation 12.47
|
—
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: Change at week two compared to baseline.Population: Per protocol (PP) population
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.
Outcome measures
| Measure |
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
n=109 Participants
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.
|
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
n=108 Participants
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.
|
Total (Female)
Total females across active and placebo arms
|
Male (Active Device)
The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device.
|
Male (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.
|
Total (Males)
Total males across active and placebo arms
|
|---|---|---|---|---|---|---|
|
Change in the Beck Depression Inventory Second Edition (BDI-II) at Week Two Compared to Baseline (Per Protocol).
|
17.15 units on a scale
Interval 15.04 to 19.253
|
13.62 units on a scale
Interval 11.439 to 15.802
|
—
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: Change at weeks 1, 2, and 4 compared to baselinePopulation: Intent to Treat population (N = 255)
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.
Outcome measures
| Measure |
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
n=95 Participants
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.
|
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
n=85 Participants
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.
|
Total (Female)
n=180 Participants
Total females across active and placebo arms
|
Male (Active Device)
n=29 Participants
The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device.
|
Male (Placebo Device)
n=40 Participants
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.
|
Total (Males)
n=69 Participants
Total males across active and placebo arms
|
|---|---|---|---|---|---|---|
|
Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis)
Week 1
|
15 units on a scale
Interval 13.032 to 16.884
|
10.6 units on a scale
Interval 8.485 to 12.692
|
12.9 units on a scale
Interval 11.451 to 14.338
|
11.5 units on a scale
Interval 7.265 to 15.701
|
13.6 units on a scale
Interval 9.634 to 17.516
|
12.7 units on a scale
Interval 9.865 to 15.526
|
|
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
Interval 15.844 to 19.986
|
14.2 units on a scale
Interval 11.723 to 16.583
|
16.1 units on a scale
Interval 14.534 to 17.723
|
12.6 units on a scale
Interval 7.702 to 17.401
|
14.8 units on a scale
Interval 10.503 to 19.097
|
13.9 units on a scale
Interval 10.707 to 17.003
|
|
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
Interval 18.855 to 23.536
|
17.1 units on a scale
Interval 14.515 to 19.603
|
19.2 units on a scale
Interval 17.474 to 20.944
|
15.6 units on a scale
Interval 10.648 to 20.524
|
16.5 units on a scale
Interval 12.025 to 20.925
|
16.1 units on a scale
Interval 12.873 to 19.33
|
POST_HOC outcome
Timeframe: Change at weeks 1, 2, and 4 compared to baselinePopulation: Per protocol population
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.
Outcome measures
| Measure |
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
n=74 Participants
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.
|
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
n=64 Participants
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.
|
Total (Female)
n=23 Participants
Total females across active and placebo arms
|
Male (Active Device)
n=37 Participants
The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device.
|
Male (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.
|
Total (Males)
Total males across active and placebo arms
|
|---|---|---|---|---|---|---|
|
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
Interval -17.28 to -13.27
|
-9.79 units on a scale
Interval -12.0 to -7.59
|
-14.27 units on a scale
Interval -17.96 to -10.58
|
-12.47 units on a scale
Interval -15.37 to -9.57
|
—
|
—
|
|
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
Interval -20.49 to -15.97
|
-13.76 units on a scale
Interval -16.18 to -11.33
|
-15.53 units on a scale
Interval -19.6 to -11.47
|
-13.49 units on a scale
Interval -16.69 to -10.3
|
—
|
—
|
|
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
Interval -24.01 to -19.05
|
-17.04 units on a scale
Interval -19.7 to -14.38
|
-17.92 units on a scale
Interval -22.38 to -13.26
|
-15.25 units on a scale
Interval -18.76 to -11.75
|
—
|
—
|
POST_HOC outcome
Timeframe: Change at weeks 1, 2, and 4 compared to baselinePopulation: Per protocol population
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.
Outcome measures
| Measure |
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
n=74 Participants
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.
|
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
n=64 Participants
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.
|
Total (Female)
n=23 Participants
Total females across active and placebo arms
|
Male (Active Device)
n=37 Participants
The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device.
|
Male (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.
|
Total (Males)
Total males across active and placebo arms
|
|---|---|---|---|---|---|---|
|
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
Interval -6.49 to -4.35
|
-3.82 units on a scale
Interval -4.97 to -2.67
|
-6.13 units on a scale
Interval -8.05 to -4.21
|
-4.97 units on a scale
Interval -6.48 to -3.45
|
—
|
—
|
|
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
Interval -9.02 to -6.65
|
-6.12 units on a scale
Interval -7.39 to -4.85
|
-8.00 units on a scale
Interval -10.13 to -5.87
|
-5.85 units on a scale
Interval -7.53 to -4.17
|
—
|
—
|
|
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
Interval -10.61 to -8.35
|
-8.32 units on a scale
Interval -9.53 to -7.11
|
-8.80 units on a scale
Interval -10.82 to -6.77
|
-6.77 units on a scale
Interval -8.36 to -5.18
|
—
|
—
|
POST_HOC outcome
Timeframe: Change at weeks 1, 2, and 4 compared to baselinePopulation: Per protocol population
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.
Outcome measures
| Measure |
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
n=74 Participants
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.
|
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
n=64 Participants
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.
|
Total (Female)
n=23 Participants
Total females across active and placebo arms
|
Male (Active Device)
n=37 Participants
The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device.
|
Male (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.
|
Total (Males)
Total males across active and placebo arms
|
|---|---|---|---|---|---|---|
|
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
Interval -6.76 to -4.82
|
-4.33 units on a scale
Interval -5.37 to -3.29
|
-5.91 units on a scale
Interval -7.65 to -4.16
|
-5.55 units on a scale
Interval -6.92 to -4.18
|
—
|
—
|
|
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
Interval -8.49 to -6.42
|
-5.52 units on a scale
Interval -6.64 to -4.41
|
-6.52 units on a scale
Interval -8.38 to -4.65
|
-5.31 units on a scale
Interval -6.78 to -3.85
|
—
|
—
|
|
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
Interval -9.59 to -7.46
|
-7.45 units on a scale
Interval -8.59 to -6.3
|
-8.21 units on a scale
Interval -10.12 to -6.3
|
-6.40 units on a scale
Interval -7.9 to -4.9
|
—
|
—
|
POST_HOC outcome
Timeframe: Weeks 1, 2, and 4 following baselinePopulation: ITT population
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.
Outcome measures
| Measure |
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
n=95 Participants
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.
|
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
n=85 Participants
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.
|
Total (Female)
n=29 Participants
Total females across active and placebo arms
|
Male (Active Device)
n=40 Participants
The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device.
|
Male (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.
|
Total (Males)
Total males across active and placebo arms
|
|---|---|---|---|---|---|---|
|
Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses)
Week 1
|
37 Participants
|
20 Participants
|
9 Participants
|
18 Participants
|
—
|
—
|
|
Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses)
Week 2
|
52 Participants
|
35 Participants
|
12 Participants
|
20 Participants
|
—
|
—
|
|
Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses)
Week 4
|
68 Participants
|
47 Participants
|
14 Participants
|
21 Participants
|
—
|
—
|
POST_HOC outcome
Timeframe: Weeks 1, 2, and 4 following baselinePopulation: Per protocol population
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.
Outcome measures
| Measure |
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
n=74 Participants
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.
|
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
n=64 Participants
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.
|
Total (Female)
n=23 Participants
Total females across active and placebo arms
|
Male (Active Device)
n=37 Participants
The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device.
|
Male (Placebo Device)
n=97 Participants
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.
|
Total (Males)
n=101 Participants
Total males across active and placebo arms
|
|---|---|---|---|---|---|---|
|
Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses)
Week 1
|
30 Participants
|
12 Participants
|
9 Participants
|
15 Participants
|
39 Participants
|
27 Participants
|
|
Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses)
Week 2
|
41 Participants
|
24 Participants
|
11 Participants
|
17 Participants
|
52 Participants
|
41 Participants
|
|
Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (Per Protocol Analyses)
Week 4
|
56 Participants
|
36 Participants
|
12 Participants
|
18 Participants
|
68 Participants
|
54 Participants
|
Adverse Events
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
n=126 participants at risk
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.
|
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
n=129 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.78%
1/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
General disorders
Headache / Anxiety
|
0.79%
1/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
General disorders
Headache / Allergy
|
0.79%
1/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Nervous system disorders
Migraine
|
0.79%
1/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Nervous system disorders
Headache
|
6.3%
8/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
2.3%
3/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Gastrointestinal disorders
Decreased appetite
|
0.79%
1/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.78%
1/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
General disorders
Vision blurred / Allergy
|
0.00%
0/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.78%
1/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.79%
1/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
1.6%
2/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Infections and infestations
Sinusitis
|
1.6%
2/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.78%
1/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.79%
1/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.79%
1/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.79%
1/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Eye disorders
Photopsia
|
0.79%
1/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
General disorders
Photopsia / Skin discomfort
|
0.79%
1/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Skin and subcutaneous tissue disorders
Skin discomfort
|
0.79%
1/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.79%
1/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.78%
1/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Psychiatric disorders
Mood altered
|
2.4%
3/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Nervous system disorders
Dizziness
|
0.79%
1/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Gastrointestinal disorders
Nausea
|
0.79%
1/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
General disorders
Eye movement disorder / Skin discomfort
|
0.79%
1/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Eye disorders
Eye movement disorder
|
2.4%
3/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Nervous system disorders
Poor quality sleep
|
1.6%
2/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
1.6%
2/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Nervous system disorders
Abnormal dreams
|
0.00%
0/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.78%
1/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
|
Nervous system disorders
Hypersomnia
|
0.79%
1/126 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
0.00%
0/129 • Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant.
On each day of trial therapy through study completion, participants reported in ePRO whether or not they used the study device as instructed and if there had been a change to their health status or medications over the previous 24 hours. A free text form allowed participants to describe any changes to their health, including any adverse events, during trial therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place