Ketamine Biomarker Validation
ConditionTreatment Resistant Depression (TRD)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-59
SponsorSoterix Medical
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 years (i.e., still at age of risk for a psychotic disorder)
Receipt of electroconvulsive therapy within 3 months of enrolling in the study
History of IV drug use
Trial design
Treatments tested in this trial
- Ketamine (0.25 mg/kg)
- Ketamine (0.5 mg/kg)
- Ketamine (0.75 mg/kg)
Treatment groups
20 Participants
are divided into 3 treatment groupsSponsors and collaborators
Soterix Medical
Lead sponsor
Columbia University
Collaborator
Source ClinicalTrials.gov