Longitudinal PET Imaging of Antipsychotic Binding to the Dopamine-3 Receptor in Schizophrenia
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. \[11C\]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.
Timeline
- Start
- 2026-12-01
- Primary completion
- 2030-08-30
- Completion
- 2030-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brexpiprazole | Small molecule | 1 mg | — |
| Subject | Brexpiprazole | Small molecule | 2 mg | — |
| Subject | Brexpiprazole | Small molecule | 3 mg | — |
| Subject | Brexpiprazole | Small molecule | 4 mg | — |
| Subject | Cariprazine | Small molecule | 1 mg | — |
| Subject | Cariprazine | Small molecule | 2 mg | — |
| Subject | Cariprazine | Small molecule | 3 mg | — |
| Subject | Cariprazine | Small molecule | 4 mg | — |