Effect of Ketamine on Neurological Activity as... — Clinical Trial Details

This prospective observational cohort (n=36) assesses brain activity via EEG before, during and after intramuscular ketamine administered as standard of care for treatment-resistant major depressive disorder; genetic markers will also be collected to explore associations with response.

Participants are patients aged 21–60 receiving IM ketamine at the study site (up to 10 sessions). EEG measurements, clinical rating scales (including MADRS), and a genetic cheek swab will be used to inform future ketamine study designs.

Inclusion Criteria:
1. DSM-5 diagnosis of treatment-resistant Major Depressive Disorder (may have secondary diagnoses of general anxiety or substance disorder).
2. Non-responders to at least 2 previous antidepressant medications prescribed by a physician in the past five years.
3. Score of ≥20 on the Montgomery–Åsberg Depression Rating Scale (MADRS).
4. All genders aged 21 to 60 years.
5. Prescribed or currently being treated with intramuscular ketamine for treatment-resistant MDD per site standard of care.
6. Willing to wear an EEG headset and an eye mask, listen to ambient sound, and provide a genetic cheek swab.

Exclusion Criteria:
1. Pregnancy.
2. Traumatic brain injury within the past 3 months.
3. Body weight < 50 kg or > 120 kg.
4. Coronary heart disease.
5. Uncontrolled hypertension as defined by ACC/AHA 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 within 24 hours prior to and 48 hours after treatment.
13. Current use of specified medications (benzodiazepines within 6 hours prior and 2 hours after treatment; lamotrigine within 6 hours prior; amphetamine-based stimulants within 6 hours prior; MAO-Is allowed with BP monitoring).

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

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Study Arms & Interventions

IM ketamine (SOC)

Interventions

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Inclusion Criteria

Exclusion Criteria

Study Details

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