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NCT06069843 · ClinicalTrials.gov registry record · Phase 2
Single-dose Ketamine Treatment to Improve Depression in Mild Cognitive Impairment
A Phase 2 study of Depression and Mild Cognitive Impairment, sponsored by Icahn School of Medicine at Mount Sinai.
- Active
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT06069843 is a Phase 2 study of Depression and Mild Cognitive Impairment that is active but no longer recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 15 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06069843, a Phase 2 study of Depression and Mild Cognitive Impairment, is active but no longer recruiting, sponsored by Icahn School of Medicine at Mount Sinai.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG IV Ketamine
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai (Depression and Anxiety Center) - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-11-01 |
| Est. Completion | 2025-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06069843
The ClinicalTrials.gov registry entry for NCT06069843 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which IV Ketamine is the first listed.
NCT06069843 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06069843 about?
NCT06069843 is a clinical study titled "Single-dose Ketamine Treatment to Improve Depression in Mild Cognitive Impairment". 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 spe...
What is the current status of trial NCT06069843?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2024-11-01. Estimated completion is 2025-09.
What conditions does trial NCT06069843 study?
This clinical trial studies the following conditions: Depression, Mild Cognitive Impairment.
What interventions are being tested in trial NCT06069843?
The interventions under investigation include: IV Ketamine (DRUG).
Who is sponsoring clinical trial NCT06069843?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06069843 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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