EEG Biomarker Development for Ketamine Administration
Soterix Medical
Summary
We will be developing an EEG-based biomarker for the effects of ketamine infusion in patients with Depression. We will be analyzing the effects of ketamine infusion on Depression symptoms and EEG signals.
Description
This trial is a biomarker development study. We will be examining the effects of various doses of ketamine infusion on depressive symptoms and EEG signals in patients with unipolar depression.
Eligibility
- Age range
- 18–59 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Physically healthy patients who meet DMS-5 criteria for a major depressive episode (MDE) in the context of MDD and who score at least 22 on the Montgomery-Åsberg Depression Rating Scale (MADRS) * If taking antidepressants, dose is stable for at least 6 weeks. Exclusion Criteria: * Lifetime history of bipolar disorder, schizoaffective disorder, schizophrenia, or any other psychotic disorder, including MDD with psychotic features * A first-degree relative with bipolar disorder, schizoaffective disorder, or schizophrenia, with the potential participant younger than 33 yea…
Interventions
- DrugKetamine (0.25 mg/kg)
Low level ketamine infusion therapy.
- DrugKetamine (0.5 mg/kg)
Medium level ketamine infusion therapy.
- DrugKetamine (0.75 mg/kg)
High level ketamine infusion therapy.
Location
- Columbia University Irving Medical CenterNew York, New York