TerminatedN/Aketamine

Effect of Ketamine on Neurological Activity as Measured by Electroencephalogram (EEG)

Sponsored by Entheon Biomedical Corp.

NCT ID
NCT05095792
Target Enrollment
1 participants
Start Date
2021-11-09
Est. Completion
2022-10-21

About This Study

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).

Conditions Studied

Treatment-resistant Depression

Interventions

  • Observational - no intervention

Eligibility

Age:21 Years - 60 Years
Healthy Volunteers:No
View full eligibility criteria
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

Study Locations (1)

Heading Health
Austin, Texas, United States

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source