Longitudinal PET Imaging of Antipsychotic Binding to the Dopamine-3 Receptor in Schizophrenia

Sponsor
New York State Psychiatric Institute
Study ID
NCT07715253
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Brexpiprazole — DRUG
    Brexpiprazole is an antipsychotic medication
  • Cariprazine — DRUG
    Cariprazine is an antipsychotic medication
  • [11C] PHNO — DRUG
    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 Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Dec 1, 2026
Status verified
Jul 2026
Primary completion
Aug 30, 2030
Completion
Nov 30, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Cariprazine 1mg
    Cariprazine 1mg daily for 15 days
  • Experimental: Cariprazine 2mg
    Cariprazine 2mg daily for 15 days
  • Experimental: Cariprazine 3mg
    Cariprazine 3mg daily for 15 days
  • Experimental: Cariprazine 4mg
    Cariprazine 4mg daily for 15 days
  • Experimental: Brexpiprazole 1mg
    Brexpiprazole 1mg daily for 15 days
  • Experimental: Brexpiprazole 2mg
    Brexpiprazole 2mg daily for 15 days
  • Experimental: Brexpiprazole 3mg
    Brexpiprazole 3mg daily for 15 days
  • Experimental: Brexpiprazole 4mg
    Brexpiprazole 4mg daily for 15 days

Primary Outcome Measure

Acute D2 and D3 Receptor Occupancy [ Time Frame: Day 1 ]

Central Contacts

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