Neural Circuit Effects of Ketamine in Depression
Study Phase: Phase 4
Recruitment Status: Recruiting
Start Date: January 31, 2024
End Date: April 30, 2028
Sibilla Masieri
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.
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Conditions:
- Depressive Disorder, Major