Trials / Unknown
UnknownNCT04963907
Alpha-Stim AID and Major Depressive Disorder
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- Sponsor
- Electromedical Products International, Inc. · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Active Alpha-Stim CES | Active Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks. |
| DEVICE | Sham Alpha-Stim CES | Sham Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks. |
Timeline
- Start date
- 2021-01-05
- Primary completion
- 2022-03-31
- Completion
- 2022-12-31
- First posted
- 2021-07-15
- Last updated
- 2021-07-15
Locations
1 site across 1 country: United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04963907. Inclusion in this directory is not an endorsement.