Depressive Disorder, MajorNCT04963907
Alpha-Stim AID and Major Depressive Disorder
A study testing Active Alpha-Stim CES in people with Depressive Disorder, Major, run by Electromedical Products International, Inc. at 1 site in United Kingdom.
Trial summary
The study will be a multi-centre parallel group, double blind, non-commercial, randomised controlled superiority trial. Study participants will be referred from Primary Care GP practices via their GP and randomised into active Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) or sham Alpha-Stim AID CES. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Active Alpha-Stim CES
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jan 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Aged 16 years and above. There is no maximum age limit.
- Diagnosis of current Major Depressive Episode (MDE). This will be confirmed using the research version of the Structured Clinical Interview for DSM-5 (SCID-5-RV) at baseline.
- A Score of ≥10 to 19 on 9-item self-rated Personal Health Questionnaire (PHQ-9).
- Have either been offered the option of antidepressant medication or have been prescribed antidepressant medication for a minimum of 6 weeks in the last 3 months.
- Capable of giving oral and written informed consent to the study.
- Agrees to return Alpha-Stim equipment at the end of the study and not to purchase this equipment privately during the study.
Who cannot join
- A score of ≥20 on the PHQ-9.
- Neurological conditions e.g. brain neoplasm, cerebrovascular events, epilepsy, neurodegenerative disorders, and prior brain surgery
- Requires urgent clinical care such as having persistent suicidal ideation, self-harm or suicidal intent.
- Known to be pregnant.
- Implantation with a pace maker, cochlear implant or an implantable cardioverter device (ICD).
- Major unstable medical illness requiring further investigation or treatment.
Show all 9Show fewer
- A diagnosis of current substance use disorder or dependence, dementia, eating disorder, bipolar disorder or non-affective psychosis because the use of CES treatment would otherwise require additional supervision or is associated with additional risk e.g. of mania in bipolar disorder. Determination of these conditions will be confirmed using a diagnostic clinical interview (SCID-5-RV).
- Completed and benefitted from/responded to psychological treatment for depression in the last 3 months or planning to commence psychological treatment in the next 6 months.
- Involved with any other clinical trial at the time of consent or 6 months prior.
Trial locations and contacts
1 site in 1 country.
Shireen Patel contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Nottingham
Nottingham
Shireen Patel, shireen.patel@nottingham.ac.uk
Catherine Kaylor-Hughes, catherine.kaylor-hughes@nottingham.ac.uk
About this study
Official title: Randomised Controlled Trial of the Clinical and Cost Effectiveness of Alpha-Stim AID Cranial Electrotherapy Stimulation (CES) in Treatment Seeking Patients With Moderate Severity Depressive Episodes in Primary Care
The study will be a multi-centre parallel group, double blind, non-commercial, randomised controlled superiority trial. Study participants will be referred from Primary Care GP practices via their GP and randomised into active Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) or sham Alpha-Stim AID CES.
- Conditions
- Depressive Disorder, Major
- Being tested
- Active Alpha-Stim CES, Sham Alpha-Stim CES
- Keywords
- Depression, Alpha-Stim, Cranial Electrotherapy Stimulation (CES)
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Alpha-Stim CESDevice
Active Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks.
Sham Alpha-Stim CESDevice
Sham Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active CES Therapy | Active comparator | Participants will be asked to use Alpha-Stim 60 minutes daily for 8 weeks. Active devices are programmed to emit a current intensity of 100 uA at 0.5 Hz and will be programmed to run for 60 minutes. Participants will not be able to adjust the settings on the devices. Receives: Device: Active Alpha-Stim CES |
| Sham CES Therapy | Sham comparator | Participants will be asked to use Alpha-Stim 60 minutes daily for 8 weeks. Sham devices are programmed to display a current intensity of 100 uA at 0.5 Hz and will be programmed to run for 60 minutes, but no current will be emitted from the device. Participants will not be able to adjust the settings on the devices. Receives: Device: Sham Alpha-Stim CES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression
Determine if there is a significant difference from baseline to 16 weeks on the Grid version of the Hamilton Depression Scale. The GRID-HAMD is a 17 item scale with scores ranging from 0-54. Higher scores indicate increased severity of depression. Scores of 0-7 is generally accepted to be within the normal range (clinical remission) and a score of 20 or above indicates moderate severity.
Measured: 16 weeks
Secondary outcomes (4)
Cost effectiveness
This will be analysed through the measurement of costs from personal, health and social care perspectives using Client Service Receipt inventory at 4, 8 and 16 weeks. The CSRI is a measure of the full health and social care cost and patient cost of treatment.
Measured: 16 weeks
Change in anxiety
Determine if there is a significant difference from baseline to 16 weeks on the Generalized Anxiety Disorder Scale. The GAD-7 is a 7-item self-rated measure of the severity of Generalized Anxiety Disorder. Scores range from 0-21. Scores of 5, 10, 15 and 20 represent cut off points for mild, moderate, moderately severe and severe anxiety.
Measured: 16 weeks
Change in quality of life - work and social functioning
Determine if there is a significant difference in quality of life related to work and social functioning from baseline to 16 weeks, as measured by the Work and Social Adjustment Scale. The WASA is a 5-item self-rated measure of work and social function. The maximum score of the WSAS is 40, lower scores indicate less impairment in functioning.
Measured: 16 weeks
Change in quality of life - health related
Determine if there is a significant difference in quality of life related to overall health using a standardized measure developed by the Euroqual group. EQ5D-5L is 5 item standardized instrument for measuring generic health status. It is used by NICE to generate quality adjusted life years for cost effectiveness assessments.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start5 Jan 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies 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
- The study is a multi-centre parallel group, double blind, non-commercial, randomised controlled trial (RCT).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Electromedical Products International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Nottingham
- Responsible party
- Sponsor
- Investigators
- Richard Morriss, MD, Principal investigator, University of Nottingham Research and Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963907
- Sponsor's protocol ID
- UK-MDDNHS
- Status last verified
- Jul 2021
- First submitted
- 25 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of the Clinical and Cost Effectiveness of Alpha-Stim AID Cranial Electrotherapy Stimulation (CES) in Treatment Seeking Patients With Moderate Severity Depressive Episodes in Primary Care
- ClinicalTrials.gov ID
- NCT04963907
- Acronym / sponsor ID
- UK-MDDNHS
- Conditions
- Depressive Disorder, Major
- Keywords
- Depression, Alpha-Stim, Cranial Electrotherapy Stimulation (CES)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Electromedical Products International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Nottingham
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be a multi-centre parallel group, double blind, non-commercial, randomised controlled superiority trial. Study participants will be referred from Primary Care GP practices via their GP and randomised into active Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) or sham Alpha-Stim AID CES.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study is a multi-centre parallel group, double blind, non-commercial, randomised controlled trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| Active CES Therapy | Active comparator | Device: Active Alpha-Stim CESParticipants will be asked to use Alpha-Stim 60 minutes daily for 8 weeks. Active devices are programmed to emit a current intensity of 100 uA at 0.5 Hz and will be programmed to run for 60 minutes. Participants will not be able to adjust the settings on the devices. |
| Sham CES Therapy | Sham comparator | Device: Sham Alpha-Stim CESParticipants will be asked to use Alpha-Stim 60 minutes daily for 8 weeks. Sham devices are programmed to display a current intensity of 100 uA at 0.5 Hz and will be programmed to run for 60 minutes, but no current will be emitted from the device. Participants will not be able to adjust the settings on the devices. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 16 years and above. There is no maximum age limit.
- Diagnosis of current Major Depressive Episode (MDE). This will be confirmed using the research version of the Structured Clinical Interview for DSM-5 (SCID-5-RV) at baseline.
- A Score of ≥10 to 19 on 9-item self-rated Personal Health Questionnaire (PHQ-9).
- Have either been offered the option of antidepressant medication or have been prescribed antidepressant medication for a minimum of 6 weeks in the last 3 months.
- Capable of giving oral and written informed consent to the study.
Key exclusion criteria (9 listed)
- A score of ≥20 on the PHQ-9.
- Neurological conditions e.g. brain neoplasm, cerebrovascular events, epilepsy, neurodegenerative disorders, and prior brain surgery
- Requires urgent clinical care such as having persistent suicidal ideation, self-harm or suicidal intent.
- Known to be pregnant.
- Implantation with a pace maker, cochlear implant or an implantable cardioverter device (ICD).
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 |
|---|---|---|
| Active Alpha-Stim CESActive Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks. | Device | Active CES Therapy |
| Sham Alpha-Stim CESSham Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks. | Device | Sham CES Therapy |
Primary outcome
Change in depression
Time frame: 16 weeks
Determine if there is a significant difference from baseline to 16 weeks on the Grid version of the Hamilton Depression Scale. The GRID-HAMD is a 17 item scale with scores ranging from 0-54. Higher scores indicate increased severity of depression. Scores of 0-7 is generally accepted to be within the normal range (clinical remission) and a score of 20 or above indicates moderate severity.
4 secondary outcomes
Cost effectiveness
Time frame: 16 weeks
Change in anxiety
Time frame: 16 weeks
Change in quality of life - work and social functioning
Time frame: 16 weeks
Change in quality of life - health related
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Depressive Disorder, Major
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Active, not recruiting
Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
Depression, MDD
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Digital Interventions for Relapse Prevention in Adolescence
Major Depression Disorder, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
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.
Shireen Patel contact
Richard Morriss, MD principal investigator
University of Nottingham Research and Innovation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Alpha-Stim CES in people with Depressive Disorder, Major, run by Electromedical Products International, Inc. at 1 site in United Kingdom.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 15 Jul 2021. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Morriss, MD (0115 8230427, richard.morriss@nottignham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2021.