Longitudinal PET Imaging of Antipsychotic Binding to the Dopamine-3 Receptor in Schizophrenia
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Ragy Girgis, MD
- Número de teléfono: 646-774-5553
- Correo electrónico: ragy.girgis@nyspi.columbia.edu
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
- 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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Experimental: Cariprazine 1mg
Cariprazine 1mg daily for 15 days
|
Cariprazine is an antipsychotic medication
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.
|
|
Experimental: Cariprazine 2mg
Cariprazine 2mg daily for 15 days
|
Cariprazine is an antipsychotic medication
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.
|
|
Experimental: Cariprazine 3mg
Cariprazine 3mg daily for 15 days
|
Cariprazine is an antipsychotic medication
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.
|
|
Experimental: Cariprazine 4mg
Cariprazine 4mg daily for 15 days
|
Cariprazine is an antipsychotic medication
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.
|
|
Experimental: Brexpiprazole 1mg
Brexpiprazole 1mg daily for 15 days
|
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.
Brexpiprazole is an antipsychotic medication
|
|
Experimental: Brexpiprazole 2mg
Brexpiprazole 2mg daily for 15 days
|
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.
Brexpiprazole is an antipsychotic medication
|
|
Experimental: Brexpiprazole 3mg
Brexpiprazole 3mg daily for 15 days
|
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.
Brexpiprazole is an antipsychotic medication
|
|
Experimental: Brexpiprazole 4mg
Brexpiprazole 4mg daily for 15 days
|
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.
Brexpiprazole is an antipsychotic medication
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Acute D2 and D3 Receptor Occupancy
Periodo de tiempo: Day 1
|
Delta BPND in poscommissural putamen and midbrain
|
Day 1
|
|
Upregulation of D3 receptor following subchronic administration of antipsychotics
Periodo de tiempo: Day 15
|
The availability of D3Rs following two weeks of antipsychotic treatment will be measured.
|
Day 15
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS) Total Positive Symptoms
Periodo de tiempo: 15 days
|
Correlations between changes in PANSS total positive symptoms and receptor binding will be examined.
|
15 days
|
|
Positive and Negative Syndrome Scale (PANSS) Total Negative Symptoms
Periodo de tiempo: 15 days
|
Correlations between changes in PANSS total negative symptom scores and receptor binding will be examined.
|
15 days
|
|
MATRICS Cognitive Deficits (Composite Score)
Periodo de tiempo: 15 days
|
Correlations between changes in cognitive deficits (MATRICS composite score) and receptor binding will be examined.
|
15 days
|
Otras medidas de resultado
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Abnormal Involuntary Movement Scale (AIMS) Score
Periodo de tiempo: 15 days
|
Correlations between changes in extrapyramidal side effect scores (AIMS) and receptor binding will be examined.
|
15 days
|
|
Simpson-Angus Scale (SAS) Score
Periodo de tiempo: 15 days
|
Correlations between changes in extrapyramidal side effect scores (SAS) and receptor binding will be examined.
|
15 days
|
|
Barnes Akathisia Rating Scale (BARS) Score
Periodo de tiempo: 15 days
|
Correlations between changes in extrapyramidal side effect scores (BARS) and receptor binding will be examined.
|
15 days
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- NYSPI2026-31
- 1R01MH139651-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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