Cranial Electrotherapy Stimulation for the Treatment of Major Depressive Disorder in Adults
CompletedNAResults postedLast updated 12 March 2024
What this trial tests
NA trial testing Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) in Major Depressive Disorder in 255 participants. Completed in 24 October 2022.
Adults 21 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in the Beck Depression Inventory Second Edition (BDI-II) at Week Two Compared to Baseline.Primary· 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.
Change in the Beck Depression Inventory Second Edition (BDI-II) at Weeks One and Four Compared to Baseline.Secondary· 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.Secondary· 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.Secondary· 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).Secondary· 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.
Change in the Beck Depression Inventory Second Edition (BDI-II) at Weeks One and Four Compared to Baseline (Per Protocol).Secondary· 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 BDI-II at Week 1 (Per protocol analysis)
Change in the Beck Depression Inventory Second Edition (BDI-II) at Week Two Compared to Baseline (Per Protocol).Secondary· 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.
Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (ITT Analysis)Secondary· Change at weeks 1, 2, and 4 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.
Week 1
Group
Value
95% CI
Female (Active Device)
15
13.032 – 16.884
Female (Placebo Device)
10.6
8.485 – 12.692
Total (Female)
12.9
11.451 – 14.338
Male (Active Device)
11.5
7.265 – 15.701
Male (Placebo Device)
13.6
9.634 – 17.516
Total (Males)
12.7
9.865 – 15.526
Week 2
Group
Value
95% CI
Female (Active Device)
17.9
15.844 – 19.986
Female (Placebo Device)
14.2
11.723 – 16.583
Total (Female)
16.1
14.534 – 17.723
Male (Active Device)
12.6
7.702 – 17.401
Male (Placebo Device)
14.8
10.503 – 19.097
Total (Males)
13.9
10.707 – 17.003
Week 4
Group
Value
95% CI
Female (Active Device)
21.2
18.855 – 23.536
Female (Placebo Device)
17.1
14.515 – 19.603
Total (Female)
19.2
17.474 – 20.944
Male (Active Device)
15.6
10.648 – 20.524
Male (Placebo Device)
16.5
12.025 – 20.925
Total (Males)
16.1
12.873 – 19.330
Change in BDI-II From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis)Secondary· Change at weeks 1, 2, and 4 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.
Week 1
Group
Value
95% CI
Female (Active Device)
-15.22
-17.28 – -13.27
Female (Placebo Device)
-9.79
-12.00 – -7.59
Male (Active Device)
-14.27
-17.96 – -10.58
Male (Placebo Device)
-12.47
-15.37 – -9.57
Week 2
Group
Value
95% CI
Female (Active Device)
-18.23
-20.49 – -15.97
Female (Placebo Device)
-13.76
-16.18 – -11.33
Male (Active Device)
-15.53
-19.60 – -11.47
Male (Placebo Device)
-13.49
-16.69 – -10.30
Week 4
Group
Value
95% CI
Female (Active Device)
-21.53
-24.01 – -19.05
Female (Placebo Device)
-17.04
-19.70 – -14.38
Male (Active Device)
-17.92
-22.38 – -13.26
Male (Placebo Device)
-15.25
-18.76 – -11.75
Change in PHQ-9 From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis)Secondary· Change at weeks 1, 2, and 4 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.
Week 1
Group
Value
95% CI
Female (Active Device)
-5.42
-6.49 – -4.35
Female (Placebo Device)
-3.82
-4.97 – -2.67
Male (Active Device)
-6.13
-8.05 – -4.21
Male (Placebo Device)
-4.97
-6.48 – -3.45
Week 2
Group
Value
95% CI
Female (Active Device)
-7.84
-9.02 – -6.65
Female (Placebo Device)
-6.12
-7.39 – -4.85
Male (Active Device)
-8.00
-10.13 – -5.87
Male (Placebo Device)
-5.85
-7.53 – -4.17
Week 4
Group
Value
95% CI
Female (Active Device)
-9.48
-10.61 – -8.35
Female (Placebo Device)
-8.32
-9.53 – -7.11
Male (Active Device)
-8.80
-10.82 – -6.77
Male (Placebo Device)
-6.77
-8.36 – -5.18
Change in QIDS From Baseline at Weeks 1, 2, and 4, Stratified by Gender (Per Protocol Analysis)Secondary· Change at weeks 1, 2, and 4 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.
Week 1
Group
Value
95% CI
Female (Active Device)
-5.79
-6.76 – -4.82
Female (Placebo Device)
-4.33
-5.37 – -3.29
Male (Active Device)
-5.91
-7.65 – -4.16
Male (Placebo Device)
-5.55
-6.92 – -4.18
Week 2
Group
Value
95% CI
Female (Active Device)
-7.46
-8.49 – -6.42
Female (Placebo Device)
-5.52
-6.64 – -4.41
Male (Active Device)
-6.52
-8.38 – -4.65
Male (Placebo Device)
-5.31
-6.78 – -3.85
Week 4
Group
Value
95% CI
Female (Active Device)
-8.53
-9.59 – -7.46
Female (Placebo Device)
-7.45
-8.59 – -6.30
Male (Active Device)
-8.21
-10.12 – -6.30
Male (Placebo Device)
-6.40
-7.90 – -4.90
Subgroup Analysis - Proportion of Subjects Achieving at Least 50% Improvement From Baseline in BDI-II (ITT Analyses)Secondary· Weeks 1, 2, and 4 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.
Week 1
Group
Value
95% CI
Female (Active Device)
37
Female (Placebo Device)
20
Male (Active Device)
9
Male (Placebo Device)
18
Week 2
Group
Value
95% CI
Female (Active Device)
52
Female (Placebo Device)
35
Male (Active Device)
12
Male (Placebo Device)
20
Week 4
Group
Value
95% CI
Female (Active Device)
68
Female (Placebo Device)
47
Male (Active Device)
14
Male (Placebo Device)
21
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected from the beginning through the end of the treatment period for a total of four weeks per trial participant..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Other Fisher Wallace Laboratories trials
Trials by the same sponsor.
NCT07093736 — A Study Comparing Immediate Treatment to Deferred Treatment With the Fisher Wallace (FW) Stimulator FW-200 Device for th
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fisher Wallace Laboratories
Last refreshed: 12 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05384041.