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Alpha-Stim AID and Major Depressive Disorder

NCT04963907 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2021-07-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Nottingham

    collaborator OTHER

  • Electromedical Products International, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Morriss, MD · University of Nottingham Research and Innovation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-05
Primary Completion
2022-03-31
Completion
2022-12-31
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04963907 on ClinicalTrials.gov