Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
230 participants
INTERVENTIONAL
2021-01-05
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active CES Therapy
Participants will be asked to use Alpha-Stim 60 minutes daily for 8 weeks. Active devices are programmed to emit a current intensity of 100 uA at 0.5 Hz and will be programmed to run for 60 minutes. Participants will not be able to adjust the settings on the devices.
Active Alpha-Stim CES
Active Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks.
Sham CES Therapy
Participants will be asked to use Alpha-Stim 60 minutes daily for 8 weeks. Sham devices are programmed to display a current intensity of 100 uA at 0.5 Hz and will be programmed to run for 60 minutes, but no current will be emitted from the device. Participants will not be able to adjust the settings on the devices.
Sham Alpha-Stim CES
Sham Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks.
Interventions
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Active Alpha-Stim CES
Active Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks.
Sham Alpha-Stim CES
Sham Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
16 Years
ALL
Yes
Sponsors
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University of Nottingham
OTHER
Electromedical Products International, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Morriss, MD
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham Research and Innovation
Locations
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University of Nottingham
Nottingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UK-MDDNHS
Identifier Type: -
Identifier Source: org_study_id
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