Clinical trial NCT04963907: Alpha-Stim AID and Major Depressive Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Disorder, Major
Keywords: Depression
Alpha-Stim
Cranial Electrotherapy Stimulation (CES)
Lead sponsor: Electromedical Products International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Nottingham
First posted: 2021-07-15
Enrollment: 230
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a multi-centre parallel group, double blind, non-commercial, randomised controlled trial (RCT).
Primary purpose: TREATMENT

Brief 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 Criteria:

* Aged 16 years and above. There is no maximum age limit.
* Diagnosis of current Major Depressive Episode (MDE). This will be confirmed using the research version of the Structured Clinical Interview for DSM-5 (SCID-5-RV) at baseline.
* 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 been prescribed 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 this equipment privately during the study.

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-harm or 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, eating disorder, bipolar disorder or non-affective 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. Determination of these conditions will be confirmed using a diagnostic clinical interview (SCID-5-RV).
* 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.
* Involved with any other clinical trial at the time of consent or 6 months prior.

Primary outcomes:
measure: Change in depression
timeFrame: 16 weeks
Secondary outcomes:
measure: Cost effectiveness
timeFrame: 16 weeks
measure: Change in anxiety
timeFrame: 16 weeks
measure: Change in quality of life - work and social functioning
timeFrame: 16 weeks
measure: Change in quality of life - health related
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham Research and Innovation
name: Richard Morriss, MD
role: PRINCIPAL_INVESTIGATOR
References: