Status:
ACTIVE_NOT_RECRUITING
Single-dose Ketamine Treatment to Improve Depression in Mild Cognitive Impairment
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Depression
Mild Cognitive Impairment
Eligibility:
All Genders
50-90 years
Phase:
PHASE2
Brief Summary
Ketamine is a NMDA-receptor antagonist that promotes synapse formation and has been shown to rapidly improve symptoms in depression. Even a single dose of ketamine has been shown to improve depression...
Detailed Description
Ketamine is a rapid-acting antidepressant thought to work, at least in part, by the enhancement of neural plasticity and the growth of new synapses. A single dose of ketamine has been shown to improve...
Eligibility Criteria
Inclusion
- Age 50-90
- Able to give consent
- Montgomery Asberg Depression Rating Scale (MADRS) score of ≥20 consistent with at least "moderate depression"
- Clinical diagnosis of mild cognitive impairment or mild Alzheimer's Disease
Exclusion
- Serious unstable medical illness
- Uncontrolled hypertension
- Abnormal electrocardiogram
- Renal impairment defined as BUN 20 mg/dl and/or creatinine clearance \>1.3
- Current drug or alcohol use disorder
- History of seizures without a clear or resolved etiology
- Lifetime history of schizophrenia, schizoaffective disorder, or bipolar 1 or 2 disorder
- Montreal Cognitive Assessment (MoCA) score \<18
- Presence of psychotic symptoms or lifetime psychotic disorder
- Recreational ketamine or phencyclidine use in the last 2 years
- BMI\>40
- Serious or imminent suicidal or homicidal risk
- Systolic blood pressure \>165 or diastolic blood pressure \>95 on infusion day
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06069843
Start Date
November 1 2024
End Date
September 1 2025
Last Update
January 29 2025
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai (Depression and Anxiety Center)
New York, New York, United States, 10029