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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: Active Phase 2 study of Depression and Mild Cognitive Impairment, sponsored by Icahn School of Medicine at Mount Sinai.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Number of symptom events as assessed by the patient in a self-report measure. PRISE assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other)

Interventions

  • DRUG IV Ketamine

Study Locations (1)

New York

  • Icahn School of Medicine at Mount Sinai (Depression and Anxiety Center) - New York

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2024-11-01
Est. Completion 2025-09
Phase Phase 2

What the registry record for NCT06069843 still lists

NCT06069843 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower).

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 a single indexed study location in 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.

Similar trials for Depression

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06069843's enrollment target sits among peer trials

15 641st of 679 higher than 33 of 679 other Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06069843, the US trial registry maintained by the National Library of Medicine. NCT06069843 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.