NCT06213324 Neural Circuit Effects of Ketamine in Depression
| NCT ID | NCT06213324 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-01-31 |
| Primary Completion | 2028-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2024-01-31 with a primary completion date of 2028-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Sibilla Masieri
✉ sibilla.masieri@mssm.eduJames Murrough, MD/PhD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT06213324 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06213324 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06213324 currently recruiting?
Yes, NCT06213324 is actively recruiting participants. Contact the research team at sibilla.masieri@mssm.edu for enrollment information.
Where is the NCT06213324 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06213324 clinical trial?
NCT06213324 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is James Murrough, MD/PhD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 120 participants.