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Active, not recruitingPhase 2

Single-dose Ketamine Treatment to Improve Depression in Mild Cognitive Impairment

NCT06069843 · Icahn School of Medicine at Mount Sinai

Closed to entry
Status
Not accepting participants
Phase 2
Phase
15
Target enrolment
1
Study sites
1 US states

What it is testing

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 and cognition with short-term memory, inhibitory control, cognitive flexibility, and processing speed showing improvements within days of treatment. The mechanism behind ketamine's rapid action is not clear but some groups have speculated it may be related to enhanced neuroplasticity, particularly in the frontal areas and the hippocampus. If this mechanism is accurate, ketamine may be especially effective in treating mild cognitive impairment and depression (MCI-D) where changes in the hippocampus and frontal areas have been implicated. Although few studies have been published on the effects of ketamine in older adults, some small pilot studies suggest that ketamine treatment might be effective in improving depression in older adults and relatively safe. There are no studies looking at the effects of ketamine treatment in patients with MCI-D. The research team hypothesize that IV ketamine treatment will be well-tolerated and will improve depression and cognition in patients with MCI-D. The study team will explore the effects of brain imaging abnormalities and amyloid biomarker status on the responsiveness to ketamine. The study team will conduct an open-label pilot study designed to gather data to support an application for a larger NIH-funded study.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Number and severity of symptom events as assessed by the Patient Rated Inventory of Side Effects (PRISE)

    Measured over end of study, at 1 month

  • Severity of symptom events as assessed by the Patient Rated Inventory of Side Effects (PRISE)

    Measured over end of study, at 1 month

  • Frequency of symptoms measured using PRISE

    Measured over end of study, at 1 month

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

50 Years to 90 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * 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 Criteria: * 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

Where

1 study site

FacilityCityRegionCountry
Icahn School of Medicine at Mount Sinai (Depression and Anxiety Center)New YorkNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06069843 on ClinicalTrials.gov →

Last updated in the registry 2025-01-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits