Alpha-Stim AID and Major Depressive Disorder

Last updated: July 6, 2021
Sponsor: Electromedical Products International, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Treatment

N/A

Clinical Study ID

NCT04963907
UK-MDDNHS
  • Ages > 16
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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 theresearch version of the Structured Clinical Interview for DSM-5 (SCID-5-RV) atbaseline.
  • 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 beenprescribed 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 thisequipment privately during the study.

Exclusion

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-harmor 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, eatingdisorder, bipolar disorder or non-affective psychosis because the use of CES treatmentwould otherwise require additional supervision or is associated with additional riske.g. of mania in bipolar disorder. Determination of these conditions will be confirmedusing a diagnostic clinical interview (SCID-5-RV).
  • Completed and benefitted from/responded to psychological treatment for depression inthe last 3 months or planning to commence psychological treatment in the next 6months.
  • Involved with any other clinical trial at the time of consent or 6 months prior.

Study Design

Total Participants: 230
Study Start date:
January 05, 2021
Estimated Completion Date:
December 31, 2022

Connect with a study center

  • University of Nottingham

    Nottingham,
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.