Last updated: July 6, 2021
Sponsor: Electromedical Products International, Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Depression
Treatment
N/AClinical Study ID
NCT04963907
UK-MDDNHS
Ages > 16 All Genders Accepts Healthy Volunteers
Study Summary
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 KingdomActive - 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.