Depression Clinical Trial
Official title:
Understanding Neural Mechanisms Associated With Cranial Electrotherapy Stimulation in Depression
NCT number | NCT04587531 |
Other study ID # | UK-MDDEEG |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | July 5, 2021 |
Est. completion date | July 17, 2023 |
Verified date | November 2023 |
Source | Electromedical Products International, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will examine the effect of cranial electrotherapy stimulation (CES) treatment on adults with depression. Scalp based electroencephalogram (EEG) will be utilized to record the brain activity of participants whilst they perform computer based tasks. The aim is to understand if there would be changes in the neural signals following CES.
Status | Terminated |
Enrollment | 1 |
Est. completion date | July 17, 2023 |
Est. primary completion date | July 17, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Male or female subjects, 18 to 65 years of age. - Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document. - Subjects must fulfil ICD-10 criteria for Depressive Episode or Recurrent Depressive Disorders based on clinical assessment and confirmed by short a structured diagnostic interview, MINI. - Subjects must have an initial score of at least 14 on the BDI at screen and at baseline of study. - Current depressive episode of at least 4 weeks duration. Exclusion Criteria: - Current or past diagnosis of any other major mental disorders (e.g., schizophrenia, bipolar affective disorders) - Depression with psychotic symptoms - Dysthymia - Depression of organic origin - Substance misuse/ dependence - Subjects with one or more seizures without a clear and resolved etiology. - Female subjects who are pregnant. - Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Oxford Brooke University | Oxford |
Lead Sponsor | Collaborator |
---|---|
Electromedical Products International, Inc. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Electroencephalogram (EEG) pre-and post-treatment | Scalp based EEG to measure changes in neural signals | Pre-treatment; 1 month, 3 months, and 6 months post-treatment | |
Primary | Change in Beck Depression Inventory score | Self-report standardized measure of depression with scores ranging from 0-63 with higher scores indicating more severe depression. | Week 1 and Week 6 | |
Primary | Change in Hamilton Depression Rating Scale | Clinician rated standardized measure of depression with scores ranging from 0-50, with higher scores indicating more severe depression. | Week 1 and Week 6 |
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