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RecruitingPhase 4

Neural Circuit Effects of Ketamine in Depression

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how a brain area is linked to anxiety and loss of pleasure in people with depression. It also tests how ketamine affects brain activity and depression symptoms right away and over time. Adults ages 18–65 with depression and healthy adults may join.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: Be 18–65 years old.
  • Both groups: Be able to give informed consent, meaning you understand the study and agree to join.
  • Both groups: Be able to follow study requirements, as judged by the study leader.
  • Depression group: Have major depression with a current episode that is at least moderate in severity.
  • Both groups: Women must use reliable, medically accepted birth control unless they cannot become pregnant due to surgery or have been past menopause for at least one year.
  • Both groups: Women using birth control pills must also use a barrier method, such as condoms.
  • Depression group: Women who can become pregnant must have negative pregnancy tests at screening and before the ketamine infusion.

Who can't join

  • Depression group: Current or past schizophrenia, other disorders or episodes involving loss of touch with reality, bipolar disorder, or disorders of brain development, memory, or thinking. Healthy group: Any current or past mental health disorder or disorder of brain development, memory, or thinking.
  • Both groups: A substance use disorder within the past 2 years, or a positive urine drug test at screening, except for cannabis. Depression group: Any past ketamine use disorder.
  • Depression group: Antidepressant use within 2 weeks before the baseline visit, or within 4 weeks for fluoxetine; or severe current illness rated above 5 on the study’s illness scale.
  • Both groups: Unstable medical illness or important problems found on lab tests or a physical exam. Depression group: Important problems on a heart tracing test, or any condition the study doctor thinks could harm safety or data quality.
  • Both groups: Being pregnant or breastfeeding. Depression group: Also planning to become pregnant.
  • Both groups: Active intent or a plan to end your life, or a score above 2 on the study’s suicide risk scale.
  • Both groups: Being unable to safely have an MRI scan, including fear of small spaces, magnetic material or implants in the body, or a pacemaker.
  • Both groups: Being unable to lie still for at least 1 hour for an MRI scan.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

NY