Schizoaffective DisorderPhase 1NCT07715253
Longitudinal PET Imaging of Antipsychotic Binding to the Dopamine-3 Receptor in Schizophrenia
A Phase 1 study testing Brexpiprazole, Cariprazine and [11C] PHNO in people with Schizoaffective Disorder and Schizophreniform Disorder, run by New York State Psychiatric Institute.
Trial summary
This is a clinical trial in which 40 participants with schizophrenia will be randomized to 15 days of treatment with cariprazine (CAR) or brexpiprazole (BREX) in a single-blind manner. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizoaffective Disorder, Schizophreniform Disorder, Schizophrenia
- What is being tested?
- Brexpiprazole, Cariprazine and [11C] PHNO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Nov 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals, any gender or sex, aged 18 to 55, inclusive at screen
- Capable of understanding the study procedures and able to provide informed consent
- Diagnosed with schizophrenia, schizoaffective, or schizophreniform disorder
- Negative urine toxicology
- 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.]
- PANSS total score > 80 and < 120 (inclusive)
Who cannot join
- Diagnosis of substance use disorder within the previous month
- A history of poor or inadequate response or hypersensitivity to CAR or BREX for any reason
- EKG abnormality that is clinically significant including a QTc interval > 450 msec for men and > 470 msec for women,
- 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)
- Any clinically significant or unstable medical/neurological illness, condition, or disorder that is anticipated to potentially compromise participant safety on study medication
- 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.
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- 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
- A history of treatment resistance to antipsychotics or who have a duration of illness of greater than 20 years
- Claustrophobia
- Use of nicotine products within the previous month (prior to first PET scan)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a clinical trial in which 40 participants with schizophrenia will be randomized to 15 days of treatment with cariprazine (CAR) or brexpiprazole (BREX) in a single-blind manner. [11C]PHNO PET scans will be obtained before treatment and after 1 day and 15 days of treatment to examine the effects of antipsychotic medications on the dopamine-3 receptor (D3R). The overall objectives of the current study are to: 1) measure the acute binding of CAR/BREX to the D3R; 2) measure D3R availability for evidence of upregulation following subchronic administration of CAR/BREX in the same set of patients; 3) examine relationships between subchronic binding of CAR/BREX to, and upregulation of, the D3R vs. D2R and changes in positive symptoms, negative symptoms, and cognitive deficits. Relationships between subchronic binding of CAR/BREX and EPS will be explored.
Read the detailed description
There is a great need for the development of new treatments for schizophrenia (SCZ). Aside from the recently approved muscarinic agonist xanomeline, all current treatments have been assumed to function by blocking dopamine-2 receptors (D2Rs). Interest in the dopamine-3 receptor (D3R) was encouraged by preclinical findings that D3R antagonists reverse cognitive impairment and improve negative symptoms. In vivo imaging of the D3R became possible with the development of [11C]-(+)-PHNO, a D3R-preferring radioligand. However, while numerous preclinical studies have demonstrated that the D3R is relevant to both the neurobiology and treatment of SCZ, in vivo studies initially and surprisingly reported that, after several weeks of administration, antipsychotic medications may not bind to the D3R and may paradoxically increase levels of the D3R. These findings were discrepant with our own findings in non-human primates and individuals with SCZ demonstrating that acute doses of antipsychotic medications bind to the D3R and D2R in ratios predicted by their in vitro binding profiles. In a later study conducted by our group, 10 days of chronic dosing of the D2R-preferring antipsychotic medication brexpiprazole (BREX) also led to increased levels of the D3R at 1mg and negligible binding at 4mg. Finally, in our study of the D3R-preferring antipsychotic medication cariprazine (CAR), there was robust binding to the D3R and D2R after both acute and subchronic dosing. These seemingly discrepant findings may be related to methodological differences, differences in the binding profiles of D2R- vs. D3R-preferring antipsychotic medications, or to homeostatic responses to chronic antipsychotic treatment (i.e., upregulation). Upregulation is a potentially critical, though underexamined, effect common to all D2R/D3R-binding antipsychotic medications, including partial agonists. It has been hypothesized to be largely responsible for differences in occupancy estimates from single and repeat dose studies and contribute to waning effects of antipsychotic medications and tardive dyskinesia. The goals of this proposal are to elucidate the contribution of D3R, compared to D2R, binding to antipsychotic action, both acutely (SA1) and subchronically (SA2), in the same patients. The relationship between occupancy, upregulation, and clinical effects (SA3, EA) will be investigated.
- Being tested
- Brexpiprazole, Cariprazine, [11C] PHNO
- Keywords
- schizophrenia
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrexpiprazoleDrug
Brexpiprazole is an antipsychotic medication
CariprazineDrug
Cariprazine is an antipsychotic medication
[11C] PHNODrug
This is the radiotracer that will be used to examine antipsychotic binding to D2 and D3 receptors in this study. It is experimental and used for imaging purposes.
| Study group | Role | What they receive |
|---|---|---|
| Cariprazine 1mg | Experimental | Cariprazine 1mg daily for 15 days Receives: Drug: Cariprazine; Drug: [11C] PHNO |
| Cariprazine 2mg | Experimental | Cariprazine 2mg daily for 15 days Receives: Drug: Cariprazine; Drug: [11C] PHNO |
| Cariprazine 3mg | Experimental | Cariprazine 3mg daily for 15 days Receives: Drug: Cariprazine; Drug: [11C] PHNO |
| Cariprazine 4mg | Experimental | Cariprazine 4mg daily for 15 days Receives: Drug: Cariprazine; Drug: [11C] PHNO |
| Brexpiprazole 1mg | Experimental | Brexpiprazole 1mg daily for 15 days Receives: Drug: Brexpiprazole; Drug: [11C] PHNO |
| Brexpiprazole 2mg | Experimental | Brexpiprazole 2mg daily for 15 days Receives: Drug: Brexpiprazole; Drug: [11C] PHNO |
| Brexpiprazole 3mg | Experimental | Brexpiprazole 3mg daily for 15 days Receives: Drug: Brexpiprazole; Drug: [11C] PHNO |
| Brexpiprazole 4mg | Experimental | Brexpiprazole 4mg daily for 15 days Receives: Drug: Brexpiprazole; Drug: [11C] PHNO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute D2 and D3 Receptor Occupancy
Delta BPND in poscommissural putamen and midbrain
Measured: Day 1
Upregulation of D3 receptor following subchronic administration of antipsychotics
The availability of D3Rs following two weeks of antipsychotic treatment will be measured.
Measured: Day 15
Secondary outcomes (3)
Positive and Negative Syndrome Scale (PANSS) Total Positive Symptoms
Correlations between changes in PANSS total positive symptoms and receptor binding will be examined.
Measured: 15 days
Positive and Negative Syndrome Scale (PANSS) Total Negative Symptoms
Correlations between changes in PANSS total negative symptom scores and receptor binding will be examined.
Measured: 15 days
MATRICS Cognitive Deficits (Composite Score)
Correlations between changes in cognitive deficits (MATRICS composite score) and receptor binding will be examined.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Aug 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizoaffective DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Columbia University, Stony Brook Medicine
- Responsible party
- Principal investigator, Ragy Girgis, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715253
- Sponsor's protocol ID
- NYSPI2026-31
- Other IDs
- 1R01MH139651-01A1
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared via the NIH data archive.