Major Depressive DisorderCES-MDDNCT05384041
Cranial Electrotherapy Stimulation for the Treatment of Major Depressive Disorder in Adults
A study testing Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) in people with Major Depressive Disorder, run by Fisher Wallace Laboratories at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2022to 24 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-65 years and a resident of the United States of America
- Meets DSM-5 diagnostic criteria for moderate to severe Major Depressive Disorder
- Baseline BDI-II score between 20 and 63, inclusive (in moderate to severe range)
- Able to receive packages to their home via United Parcel Service/Fedex/United States Postal Service or other delivery service
- Willing and able to send and receive study related text messages on an internet capable mobile device throughout the duration of the study
- Owns and uses a personal, verifiable email address
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- 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
- Willing to abstain from use of recreational drugs, hypnotics, steroids, and/or marijuana products through study completion
- Willingness to not initiate treatment for a mental health issue during the course of the study
- Fluent in English
- 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
- In the opinion of the investigator, able to comply with study requirements and complete the study
Who cannot join
- History of suicide attempt or active suicidal ideation with plan or intent in the past 30 days.
- In the opinion of the investigator, considered high risk of suicide
- Previous hospitalization or institutionalization for mental health condition within one year of study entry
- Underwent electronic brain stimulation or neuromodulation within the past one year, including CES, transcranial magnetic stimulation, electroconvulsive therapy, and deep brain stimulation
- Modification of prescription medications that affect the nervous system (e.g., psychotropic medications) within 30 days of study entry
- Use of recreational drugs, hypnotics, steroids, and/or marijuana products in the past 30 days
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- History of alcohol use disorder or other substance use disorder in the past 12 months
- Females currently pregnant or planning to conceive during study participation, or unwilling to comply with birth control requirements
- Known history of heart disease
- Known history of trigeminal neuralgia
- Implanted with an electronic device such as a defibrillator, deep brain stimulator, or pacemaker
- Unstable medical condition including any condition requiring hospitalization or change in treatment in the prior 30 days
- Legally blind and/or deaf and without in-home care service to assist with study participation
- 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
- Current participation in another investigational study or participated in an investigational study within the past 30 days
- In the opinion of the investigator, may not be able to comply with study requirements
- Any employee, family member, or personal associate of the Sponsor or their designees conducting the study
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Neuromodulation Medical, PLLC
New York, New York, 10023
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Fisher Wallace Cranial Electrotherapy Stimulator (Active Device), Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
- Keywords
- MDD, Depression, Depressive Disorder, Major Depressive Disorder, Cranial Electrotherapy Stimulation, FW-200
- Medical subject headings
- Depressive Disorder, Major, Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)Device
Also called Fisher Wallace Stimulator FW-200, FW-200
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)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.
| Study group | Role | What they receive |
|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Active comparator | The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device. Receives: Device: Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) |
| Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) | Placebo comparator | 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. Receives: Device: Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change at week two compared to baseline.
Secondary outcomes (4)
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.
Measured: Change at weeks one and four compared to baseline.
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.
Measured: Change at weeks one, two, and four compared to baseline.
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.
Measured: Change at weeks one, two, and four compared to baseline.
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.
Measured: Four weeks following baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start28 Apr 2022
- Primary completion30 Sep 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pivotal Study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher Wallace Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA, Climb Technologies, Inc.
- Responsible party
- Sponsor
- Investigators
- Kyle Lapidus, MD, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384041
- Sponsor's protocol ID
- FW-200-05
- Acronym
- CES-MDD
- Status last verified
- Feb 2024
- First submitted
- 12 May 2022
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Gehrman PR, Bartky EJ, Travers C, Lapidus K. A Fully Remote Randomized Trial of Transcranial Alternating Current Stimulation for the Acute Treatment of Major Depressive Disorder. J Clin Psychiatry. 2024 Apr 22;85(2):23m15078. doi: 10.4088/JCP.23m15078.
PubMed 38696220
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Electrotherapy Stimulation for the Treatment of Major Depressive Disorder in Adults
- ClinicalTrials.gov ID
- NCT05384041
- Acronym / sponsor ID
- CES-MDD / FW-200-05
- Conditions
- Major Depressive Disorder
- Keywords
- MDD, Depression, Depressive Disorder, Major Depressive Disorder, Cranial Electrotherapy Stimulation, FW-200
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Fisher Wallace LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA, Climb Technologies, Inc.
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Posted 25 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pivotal Study
| Arm | Type | Receives |
|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) | Active comparator | Device: 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 (Placebo Device) | Placebo comparator | Device: 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 21-65 years and a resident of the United States of America
- Meets DSM-5 diagnostic criteria for moderate to severe Major Depressive Disorder
- Baseline BDI-II score between 20 and 63, inclusive (in moderate to severe range)
- Able to receive packages to their home via United Parcel Service/Fedex/United States Postal Service or other delivery service
- Willing and able to send and receive study related text messages on an internet capable mobile device throughout the duration of the study
Key exclusion criteria (17 listed)
- History of suicide attempt or active suicidal ideation with plan or intent in the past 30 days.
- In the opinion of the investigator, considered high risk of suicide
- Previous hospitalization or institutionalization for mental health condition within one year of study entry
- Underwent electronic brain stimulation or neuromodulation within the past one year, including CES, transcranial magnetic stimulation, electroconvulsive therapy, and deep brain stimulation
- Modification of prescription medications that affect the nervous system (e.g., psychotropic medications) within 30 days of study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)Also: Fisher Wallace Stimulator FW-200, FW-200The 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. | Device | Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) |
| 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. | Device | Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) |
Primary outcome
Change in the Beck Depression Inventory Second Edition (BDI-II) at Week Two Compared to Baseline.
Time frame: 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.
4 secondary outcomes
Change in the Beck Depression Inventory Second Edition (BDI-II) at Weeks One and Four Compared to Baseline.
Time frame: Change at weeks one and four compared to baseline.
Change in the Patient Health Questionnaire-9 (PHQ-9) at Weeks One, Two, and Four Compared to Baseline.
Time frame: Change at weeks one, two, and four compared to baseline.
Change in the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) at Weeks One, Two, and Four Compared to Baseline.
Time frame: Change at weeks one, two, and four compared to baseline.
Beck Depression Inventory Second Edition (BDI-II) Responder Rate by Time Point (% of Subjects With a 50% or Better Improvement in Score From Baseline).
Time frame: Four weeks following baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38696220Gehrman PR, Bartky EJ, Travers C, Lapidus K. A Fully Remote Randomized Trial of Transcranial Alternating Current Stimulation for the Acute Treatment of Major Depressive Disorder. J Clin Psychiatry. 2024 Apr 22;85(2):23m15078. doi: 10.4088/JCP.23m15078.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Lapidus, MD, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) in people with Major Depressive Disorder, run by Fisher Wallace Laboratories at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Beck Depression Inventory Second Edition (BDI-II) at Week Two Compared to Baseline. (time frame: Change at week two compared to baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05384041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.