Treatment-resistant Depression Clinical Trial
Official title:
Evaluation of the Effect of Ketamine on Neurological Activity as Measured by Quantitative EEG
NCT number | NCT05095792 |
Other study ID # | EBIQ-101 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 9, 2021 |
Est. completion date | October 21, 2022 |
Verified date | November 2022 |
Source | Entheon Biomedical Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This observational study will allow data to be collected to demonstrate changes in brain activity following administration of standard of care (SOC) Ketamine. By comparing genetic markers across participants, data on impact of genetic markers and response to Ketamine will also be analysed. This data will contribute to the design of future studies utilizing Ketamine for various psychiatric disorders. This study will focus on treatment-resistant Major Depressive Disorder (MDD).
Status | Completed |
Enrollment | 1 |
Est. completion date | October 21, 2022 |
Est. primary completion date | October 21, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Primary Diagnostic and Statistical Manuel of Mental Disorders 5 (DSM-V) diagnosis of treatment-resistant Major Depressive Disorder (may have secondary diagnoses of general anxiety, substance disorder) - Non-responders to at least 2 previous anti-depressant medications prescribed by a physician in the past five years - Score of =20 on Montgomery-Asberg Depression Rating Scale (MADRS) (i.e., moderate to severe depression) 2. All genders aged 21 to 60 years of age 3. Prescribed Ketamine or currently being treated with Ketamine for treatment-resistant Major Depressive Disorder 4. Willing to wear an Electroencephalogram (EEG) headset and an eye mask 5. Willing to listen to ambient sound 6. Willing to have a genetic cheek swab Exclusion Criteria: 1. Pregnancy 2. Traumatic Brain Injury within past 3 months 3. Body weight < 50 kg or > 120 kg 4. Coronary heart disease 5. Uncontrolled hypertension as defined in the American College of Cardiology/American Heart Association (ACC/AHA) Hypertension Guidelines 6. Previous contact with Ketamine (therapeutically or recreationally) outside of treatment at the study site 7. Primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder) 8. Bipolar disorder with current manic, hypomanic or mixed state 9. Post-traumatic stress disorder 10. Obsessive-compulsive disorder 11. Primary substance-use disorder 12. Alcohol consumption 24 hours prior and 48 hours subsequent to treatment 13. Currently using any of the following medications: - Benzodiazepines for 6 hours prior to treatment and 2 hours after treatment - Lamotrigine for 6 hours prior to treatment - Amphetamine-based stimulants for 6 hours prior to treatment - Monoamine Oxidase Inhibitors (MAO-Is) may be taken but blood pressure must be monitored |
Country | Name | City | State |
---|---|---|---|
United States | Heading Health | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Entheon Biomedical Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inter and intra patient variability in neurological activity. | Observation of the the inter and intra patient variability in neurological activity. | Up to 74 days | |
Secondary | Genetic markers on neurological phenotypes | Correlation of neurological phenotypes with genetic markers | Baseline | |
Secondary | CADSS-6 correlation with neurological phenotypes | Correlation of neurological phenotypes of Clinician Administered Dissociative Symptom Scale (CADSS-6). | Up to 67 days | |
Secondary | QIDS SR-16 correlation with neurological phenotypes | Correlation of neurological phenotypes of depressed patients with Quick Inventory of Depressive Symptomatology (QIDS SR-16) | Up to 67 days | |
Secondary | PMQ-SF correlation with neurological phenotypes | Correlation of neurological phenotypes Psychedelic Music Questionnaire Short Form (PMQ-SF) | Up to 67 days |
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