Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

MDD Group - Male or female aged 18-65 years; - Ability for participant to comply with the requirements of the study as determined by the PI; - Capacity to provide informed consent; - Meets diagnostic criteria for current MDD according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5); - In a current major depressive episode (MDE) of at least moderate severity according to DSM-5; - Women must be using a medically accepted reliable means of contraception (if using an oral contraceptive medication, they must also be using a barrier contraceptive) or not be of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year). - Women of childbearing potential must have a negative pregnancy test at screening and prior to the infusion. HC Group - Male or female aged 18-65 years; - Capacity to provide informed consent; - Women must be using a medically accepted reliable means of contraception (if using an oral contraceptive medication, they must also be using a barrier contraceptive) or not be of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year). - Ability for participant to comply with the requirements of the study as determined by the PI;

Exclusion Criteria

MDD Group - Current or history of schizophrenia or other psychotic disorder/episode, bipolar disorder, neurodevelopmental disorder, or neurocognitive disorder; - Current major depressive disorder with psychotic features; - Substance use disorder within the past 2 years*; - Lifetime history of ketamine use disorder; - Antidepressant medication within 2 weeks of Baseline (4 weeks for fluoxetine); - Severe current illness as reflected by a CGI score >5; - Any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease; - Clinically significant abnormalities of laboratories, physical examination, or ECG; - Positive urine toxicology screen for drugs of abuse at the time of screening, except cannabis; - Women who plan to become pregnant, are pregnant or are breast-feeding (because the medical risk of using ketamine during pregnancy and breast-feeding is unknown); - Active suicidal intent or plan; CSSRS score >2; - Any contraindications to MRI, including claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, and inability to lie still for 1 hour or more; - Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data. HC Group - Current or history of any psychiatric, neurodevelopmental disorder, or neurocognitive disorder; - Substance use disorder within the past 2 years*; - Any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease; - Clinically significant abnormalities of laboratories or physical examination; - Positive urine toxicology screen for drugs of abuse at the time of screening, except cannabis; - Current pregnancy; - Women who are breast feeding; - Active suicidal intent or plan; CSSRS score >2; - Any contraindications to MRI, including claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, and inability to lie still for 1 hour or more.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double blind

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ketamine
Participants in the ketamine arm will receive a single infusion of ketamine
  • Drug: Ketamine
    0.5 mg/kg ketamine dissolved in 100 mL saline, delivered intravenously
Placebo Comparator
Placebo
Participants in the placebo arm will receive a single placebo infusion of normal saline
  • Drug: Placebo
    Normal saline delivered intravenously

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Icahn School of Medicine at Mount Sinai

Study Contact

Julia Berman
212-241-6539
julia.berman@mssm.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.