RECRUITING

Neural Circuit Effects of Ketamine in Depression

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Neural Circuit-Specific Mechanisms of Ketamine's Effect on Anhedonia and Anxiety in Depression Using Ultra-High Field 7-Tesla MRI

Quick Facts

Study Start:2024-01-31

Study Completion:2028-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06213324

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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;	* 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. * 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.

Inclusion Criteria

Exclusion Criteria

* 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.
* 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;

* 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.
* 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.

Contacts and Locations

Study Contact

Julia Berman

CONTACT

212-241-6539

julia.berman@mssm.edu

Grace Butler

CONTACT

grace.butler@mssm.edu

Principal Investigator

James Murrough, MD/PhD

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Laurel Morris

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

James Murrough, MD/PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
Laurel Morris, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-31

Study Completion Date2028-04-30

Study Record Updates

Study Start Date2024-01-31

Study Completion Date2028-04-30

Terms related to this study

Additional Relevant MeSH Terms

Major Depressive Disorder