Alpha-Stim AID and Major Depressive Disorder

NCT04963907 | Unknown FDA Device

• 1 other identifier: UK-MDDNHS
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder, Major

Keywords

Depression; Alpha-Stim; Cranial Electrotherapy Stimulation (CES)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cost effectiveness

  16 weeks

• Change in anxiety

  16 weeks

• Change in quality of life - work and social functioning

  16 weeks

• Change in quality of life - health related

  16 weeks

Study Arms (2)

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.

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.

Device: Sham Alpha-Stim CES

Interventions

Active Alpha-Stim CES DEVICE

Active Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks.

Active CES Therapy

Sham Alpha-Stim CES DEVICE

Sham Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks.

Sham CES Therapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Electromedical Products International, Inc.: lead
• University of Nottingham: collaborator

Study Sites (1)

University of Nottingham

Nottingham, United Kingdom

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Richard Morriss, MD

  University of Nottingham Research and Innovation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Morriss, MD

CONTACT

0115 8230427; richard.morriss@nottignham.ac.uk

Shireen Patel

CONTACT

shireen.patel@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a multi-centre parallel group, double blind, non-commercial, randomised controlled trial (RCT).

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 15, 2021
• Study Start: January 5, 2021
• Primary Completion: March 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)