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Alpha-Stim AID and Major Depressive Disorder

Primary Purpose

Depressive Disorder, Major

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Active Alpha-Stim CES
Sham Alpha-Stim CES
Sponsored by
Electromedical Products International, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Depression, Alpha-Stim, Cranial Electrotherapy Stimulation (CES)

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • University of NottinghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active CES Therapy

Sham CES Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
June 25, 2021
Last Updated
July 6, 2021
Sponsor
Electromedical Products International, Inc.
Collaborators
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT04963907
Brief Title
Alpha-Stim AID and Major Depressive Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Electromedical Products International, Inc.
Collaborators
University of Nottingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Depression, Alpha-Stim, Cranial Electrotherapy Stimulation (CES)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a multi-centre parallel group, double blind, non-commercial, randomised controlled trial (RCT).
Masking
ParticipantInvestigator
Masking Description
Devices are programmed by the manufacturer prior to shipping to investigator. Active devices are programmed at 100 uA for 60 minutes, which is subsensory. Sham devices will display 100 uA and count down from 60 minutes, but will not emit a current. Neither the investigators nor the participants will know which devices are active and which are sham.
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active CES Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham CES Therapy
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active Alpha-Stim CES
Intervention Description
Active Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks.
Intervention Type
Device
Intervention Name(s)
Sham Alpha-Stim CES
Intervention Description
Sham Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks.
Primary Outcome Measure Information:
Title
Change in depression
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Cost effectiveness
Description
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.
Time Frame
16 weeks
Title
Change in anxiety
Description
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.
Time Frame
16 weeks
Title
Change in quality of life - work and social functioning
Description
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.
Time Frame
16 weeks
Title
Change in quality of life - health related
Description
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.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Morriss, MD
Phone
0115 8230427
Email
richard.morriss@nottignham.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Shireen Patel
Email
shireen.patel@nottingham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Morriss, MD
Organizational Affiliation
University of Nottingham Research and Innovation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nottingham
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shireen Patel
Email
shireen.patel@nottingham.ac.uk
First Name & Middle Initial & Last Name & Degree
Catherine Kaylor-Hughes
Email
catherine.kaylor-hughes@nottingham.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Alpha-Stim AID and Major Depressive Disorder

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