Healthy brains scanned to unlock Ketamine's secrets
NCT ID NCT05401227
First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 4 times
Summary
This study looks at how ketamine changes brain activity in 120 healthy adults. Participants will get either a study drug or a placebo for 4 days, and have two brain scans to measure these changes. The goal is to understand brain chemicals linked to psychosis, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age between 18-55 at screen 2. Medically healthy, as assessed by study physician at screen 3. Capable of understanding the study procedures and able to provide informed consent 4. Eligible men and women must agree to use a reliable method of birth control (See section 5.3) during the study. Women who are post-menopausal or otherwise not of childbearing potential are also eligible. 5. Willing and reliable to participate in XT or placebo phase as an outpatient and/or agreeable to participate as an inpatient. Exclusion Criteria: 1. Current or past Axis I psychiatric history (including Substance Use Disorder/Alcohol Use Disorder, with the exception of nicotine use disorder) as assessed at screen 2. Positive urine toxicology or alcohol at screen 3. History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine. Participants who have participated in prior research ketamine studies will be eligible. Participants can have infusions not more frequently than biweekly, and not more than 1/month on average, therefore participants entering the study will need to wait one month if they had a single infusion and 6 weeks if they have had two closely spaced infusions. 4. History of first-degree relative with schizophrenia 5. Pregnancy or breast-feeding. This exclusion criterion applies only to females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopausal). Must test negative for pregnancy at the time of screening based on a serum pregnancy test. 6. History of violence, including any history of using a gun, knife, or other weapon with intent to harm someone, as well as more than one physical fight without a weapon after the age of 18 years old (not including fights that happen during sports competition). 7. Presence or positive history of significant medical illness at screen, including: * Contraindications to XT (urinary retention, moderate or severe hepatic impairment, gastric retention, untreated narrow-angle glaucoma, hypernasality) * renal problems (GFR\<60) * high blood pressure (defined as supine systolic blood pressure (SBP) \> 140 or supine diastolic blood pressure (DBP) \> 90) * low blood pressure (defined as supine SBP \< 100, DBP \< 60) * abnormal orthostatic blood pressure (change in mean arterial pressure \[1/3 systolic + 2/3 diastolic\] of \> 20% between supine and standing blood pressures) * clinically significant cardiac illness, as determined by the site physician * clinically significant abnormal screening labs, as determined by the site physician 8. Participants with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 6 months prior to screening or participants who represent a significant risk of suicide in the opinion of the investigator. 9. Presence or positive history of neurological illness, including seizures, mental retardation or any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system (CNS), or history of significant head injury. 10. Any material in the body that is a contraindication for MRI procedures 11. Currently taking any psychotropic medication, including antidepressant medications, benzodiazepines, antipsychotic medications, mood stabilizers, anti-epileptic medications, and stimulants. We will exclude any participant who requires treatment with any psychotropic medication from one of these classes.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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NYSPI
RECRUITINGNew York, New York, 10032, United States
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