Alpha-Stim AID and Major Depressive Disorder

Electromedical Products International

Status: Unknown

Conditions: Depressive Disorder, Major

Treatments: Device: Active Alpha-Stim CES; Device: Sham Alpha-Stim CES

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04963907

UK-MDDNHS

Details and patient eligibility

About

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.

Enrollment: 230 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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230 participants in 2 patient groups

Active CES Therapy

Active Comparator group

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.

Treatment:

Device: Active Alpha-Stim CES

Sham CES Therapy

Sham Comparator group

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.

Treatment:

Device: Sham Alpha-Stim CES