Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2025-12-20
2028-03-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Low level ketamine
0.25 mg/kg ketamine infusion
Ketamine (0.25 mg/kg)
Low level ketamine infusion therapy.
Medium level ketamine
0.5 mg/kg ketamine infusion
Ketamine (0.5 mg/kg)
Medium level ketamine infusion therapy.
High level ketamine
0.75 mg/kg ketamine infusion
Ketamine (0.75 mg/kg)
High level ketamine infusion therapy.
Interventions
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Ketamine (0.25 mg/kg)
Low level ketamine infusion therapy.
Ketamine (0.5 mg/kg)
Medium level ketamine infusion therapy.
Ketamine (0.75 mg/kg)
High level ketamine infusion therapy.
Eligibility Criteria
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Inclusion Criteria
* If taking antidepressants, dose is stable for at least 6 weeks.
Exclusion Criteria
* 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
* Nonresponse or intolerance to ketamine administered either clinically or as part of a prior research study
* Pregnancy, planning to conceive, or sexually active but not using adequate birth control.
* Actively suicidal (CSSRS≥3)
* No antipsychotics or medications (e.g. benzodiazepines, anti-epileptics) that are likely to interact with GABA or glutamate,
18 Years
59 Years
ALL
No
Sponsors
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Columbia University Irving Medical Center, New York, NY
UNKNOWN
Soterix Medical
INDUSTRY
Responsible Party
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Locations
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Columbia University Irving Medical Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Yishai Valter, MS
Role: primary
Other Identifiers
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KETAEEG
Identifier Type: -
Identifier Source: org_study_id