Neural Circuit Effects of Ketamine in Depression

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Jan 9, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Neural Circuit Effects of Ketamine in Depression," is looking into how a specific part of the brain, called the subgenual anterior cingulate cortex (sgACC), affects feelings of sadness and anxiety in people with Major Depressive Disorder (MDD). The study aims to understand how ketamine, a medication often used for depression, impacts this brain area and helps alleviate depression symptoms. If you are between the ages of 18 and 65, have been diagnosed with moderate to severe depression, and can provide informed consent, you may qualify to participate in this research.

Participants in this study will receive ketamine and undergo assessments to evaluate their mental health and brain activity. It’s important to note that there are criteria that might exclude some individuals, such as those with certain psychiatric disorders or unstable medical conditions. Women who are pregnant or breastfeeding cannot participate due to unknown risks. If you’re interested in helping advance our understanding of depression and potential treatments, this study may be an opportunity for you.

Gender

ALL

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.