Clinical TrialTreatment-Resistant Depression (TRD)KetamineTerminated

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

Open-label observational study (n=36) collecting EEG and genetic data from patients with treatment-resistant MDD receiving intramuscular ketamine as standard of care.

Target Enrollment
36 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

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.

Study Protocol

Preparation

sessions

Dosing

10 sessions

Integration

sessions

Study Arms & Interventions

IM ketamine (SOC)

experimental

Observational arm of patients receiving intramuscular ketamine per site standard of care.

Interventions

  • Ketamine
    via IM• up to 10 sessions• 10 doses total

    IM ketamine administered per site standard of care; EEG measured before, during and after dosing; genetic cheek swab performed.

Participants

Ages
21 – 60
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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).

Study Details

Locations

Heading Health — Austin, Texas, United States

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