Alpha-Stim AID and Major Depressive Disorder

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04963907
• Other study ID #: UK-MDDNHS
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Electromedical Products International, Inc.
• Contact: Richard Morriss, MD
• Phone: 0115 8230427
• Email: richard.morriss[@]nottignham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Device:
• Active Alpha-Stim CES
Active Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks.
• Sham Alpha-Stim CES
Sham Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks.

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Electromedical Products International, Inc.	University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks