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

Stopped early

Conditions studied: Treatment-resistant Depression

In brief

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).

Key facts

Study ID

NCT05095792

Run by

Entheon Biomedical Corp.

People needed

1

Starts

2021-11-09

Expected to finish

2022-10-21

Last updated by the study team

2024-11-14

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• All genders aged 21 to 60 years of age
• Prescribed Ketamine or currently being treated with Ketamine for treatment-resistant Major Depressive Disorder
• Willing to wear an Electroencephalogram (EEG) headset and an eye mask
• Willing to listen to ambient sound
• Willing to have a genetic cheek swab

You may not qualify if…

• Pregnancy
• Traumatic Brain Injury within past 3 months
• Body weight < 50 kg or > 120 kg
• Coronary heart disease
• Uncontrolled hypertension as defined in the American College of Cardiology/American Heart Association (ACC/AHA) Hypertension Guidelines
• Previous contact with Ketamine (therapeutically or recreationally) outside of treatment at the study site
• Primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder)
• Bipolar disorder with current manic, hypomanic or mixed state
• Post-traumatic stress disorder
• Obsessive-compulsive disorder
• Primary substance-use disorder
• Alcohol consumption 24 hours prior and 48 hours subsequent to treatment
• 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

Where it is running

• Heading Health — Austin, Texas, United States

Full record on ClinicalTrials.gov

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