PET scans reveal how antipsychotics target key brain receptors in schizophrenia
NCT ID NCT07715253
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This study uses PET scans to see how two antipsychotic medications, brexpiprazole and cariprazine, bind to dopamine-3 receptors in the brains of people with schizophrenia. Forty participants take one of the drugs for 15 days and get brain scans before, after one day, and after 15 days. The goal is to understand how these drugs affect receptor activity and relate to symptom changes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brexpiprazole and cariprazine (antipsychotic medications) and [11C] PHNO (a radioactive tracer for PET imaging)
- What this could lead to
- If successful, this study could reveal how antipsychotics affect dopamine-3 receptors, potentially leading to better treatments for schizophrenia symptoms.
- What could go wrong
- This is a small, early-phase imaging study, not a treatment trial. Results may not translate into new therapies, and the radiotracer is experimental.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Dec 2026
An estimate. Start dates often move.
- Expected to finish
-
Nov 2030
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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. Individuals, any gender or sex, aged 18 to 55, inclusive at screen 2. Capable of understanding the study procedures and able to provide informed consent 3. Diagnosed with schizophrenia, schizoaffective, or schizophreniform disorder 4. Negative urine toxicology 5. Antipsychotic free (by choice and for reasons unrelated to the study), and for at least 3 weeks (4 for aripiprazole or LAIs) at the time of the baseline PET scan, inclusive of any antipsychotic-free time prior to consent. \[Any patient who requires inpatient hospitalization or acute medication treatment for clinical stabilization during the medication free period will not be included in this study; any participant who in the clinical judgment of the PIs or any involved clinician is not stable or appropriate for a medication free period will not be included.\] 6. PANSS total score \> 80 and \< 120 (inclusive) Exclusion Criteria: 1. Diagnosis of substance use disorder within the previous month 2. A history of poor or inadequate response or hypersensitivity to CAR or BREX for any reason 3. EKG abnormality that is clinically significant including a QTc interval \> 450 msec for men and \> 470 msec for women, 4. Pregnant or breast-feeding women. Women of child-bearing potential must have a negative serum β-hCG pregnancy test at Visit 1, must have been using an acceptable method of contraception for 30 days before the study (i.e., before the first PET or MRI scan, whichever comes first), and must agree to do so for the whole study and 30 days after (unless post-menopausal or surgically sterile) 5. Any clinically significant or unstable medical/neurological illness, condition, or disorder that is anticipated to potentially compromise participant safety on study medication 6. Any material in the body that is a contraindication for MRI procedures or participated in prior nuclear medicine procedures in the past year that exceed FDA-defined limits when combined with radiation dosimetry from PET scanning in this protocol to avoid exceeding annual dosimetry limits (metal screener repeated before MRI scan). Individuals exposed to radiation in the workplace in the previous year will be excluded. 7. Acute risk for suicide (i.e., score of 4-5 within the previous month or 6 within the previous 3 months on the CSSRS) or violence/homicide (e.g., homicidal ideation), or history of severe violent behavior or behavioral dyscontrol while antipsychotic-free 8. A history of treatment resistance to antipsychotics or who have a duration of illness of greater than 20 years 9. Claustrophobia 10. Use of nicotine products within the previous month (prior to first PET scan)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Schizoaffective disorder are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
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.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Your voice may reveal if You're taking your psychiatric medication
- Scientists probe brain's reward system in mental illness
- New schizophrenia drug targets brain glutamate, not dopamine
- New drug candidate takes aim at schizophrenia symptoms
- New schizophrenia drug goes Head-to-Head with standard antipsychotics in Long-Term trial
- Five-Year safety check for experimental schizophrenia drug