Trial investigating the effectiveness of a medical device (Alpha-Stim AID) for the treatment of depressive symptoms for patients in primary care

Phase 3

Completed

• Conditions: Reduction of depressive symptoms for patients in primary care; Mental and Behavioural Disorders; Major depressive episode

• Registration Number: ISRCTN11853110
• Lead Sponsor: niversity of Nottingham

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35379314/ (added 05/10/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36724796/ (added 02/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-14
• Study Completion: 2022-05-31
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

1. Aged =16 years
2. Diagnosis of current Major Depressive Episode (MDE)
3. A Score of =10 or 9-item self-rated Personal Health Questionnaire (PHQ-9)
4. Have either been offered the option of anti-depressant medication or prescribed antidepressant medication for a minimum of 6 weeks in the last 3 months
5. Capable of giving oral and written informed consent to the study, and this consent is confirmed by the researcher at eligibility screening and baseline assessment
6. Agrees to return Alpha-Stim equipment at the end of the study and not to purchase this equipment privately during the study

Exclusion Criteria

1. A score of =20 on the PHQ-9
2) Neurological conditions e.g. brain neoplasm, cerebrovascular events, epilepsy, neurodegenerative disorders, and prior brain surgery
3. Requiring urgent clinical care such as having persistent suicidal ideation, self-harm or suicidal intent.
4. Known to be pregnant
5. Implantation with a pacemaker or an implantable cardioverter device (ICD)
6. Major unstable medical illness requiring further investigation or treatment
7. A diagnosis of current substance use disorder or dependence, dementia, eating disorder, bipolar disorder or nonaffective 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
8. 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
9. Involved with any other clinical trial at the time of consent or 6 months prior

Study & Design

• Study Type: Interventional
• Study Design: Not specified