Neural Circuit Effects of Ketamine in Depression

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06213324
Phase
PHASE4
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Ketamine — DRUG
    0.5 mg/kg ketamine dissolved in 100 mL saline, delivered intravenously
  • Placebo — DRUG
    Normal saline delivered intravenously

Study Details

This project is designed to examine the role of the subgenual anterior cingulate cortex (sgACC) in anhedonia and anxiety in humans with depression, as well as the acute and sustained effects of ketamine on agACC activation and depression symptoms.

Key Dates

Start date
Jan 31, 2024
Status verified
Jun 2025
Primary completion
Mar 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Ketamine
    Participants in the ketamine arm will receive a single infusion of ketamine
  • Placebo Comparator: Placebo
    Participants in the placebo arm will receive a single placebo infusion of normal saline

Primary Outcome Measure

sgACC response to the Incentive Flanker Task [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Sibilla Masieri
James Murrough, MD, PhD (PRINCIPAL_INVESTIGATOR)

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