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New treatment option for Major Depressive Disorder
Official title Neural Circuit Effects of Ketamine in Depression
ClinicalTrials.gov ID: NCT06213324
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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);
You likely can't join if
- 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);
See the full eligibility 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...
- 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...
- Ability for participant to comply with the requirements of the study as determined by the PI;
- 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)...
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.