- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07715253
Longitudinal PET Imaging of Antipsychotic Binding to the Dopamine-3 Receptor in Schizophrenia
15. července 2026 aktualizováno: Ragy Girgis, New York State Psychiatric Institute
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.
Přehled studie
Postavení
Zatím nenabíráme
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
100
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Ragy Girgis, MD
- Telefonní číslo: 646-774-5553
- E-mail: ragy.girgis@nyspi.columbia.edu
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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)
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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
|
|
Experimentální: 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
|
|
Experimentální: 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
|
|
Experimentální: 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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Acute D2 and D3 Receptor Occupancy
Časové okno: Day 1
|
Delta BPND in poscommissural putamen and midbrain
|
Day 1
|
|
Upregulation of D3 receptor following subchronic administration of antipsychotics
Časové okno: Day 15
|
The availability of D3Rs following two weeks of antipsychotic treatment will be measured.
|
Day 15
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS) Total Positive Symptoms
Časové okno: 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
Časové okno: 15 days
|
Correlations between changes in PANSS total negative symptom scores and receptor binding will be examined.
|
15 days
|
|
MATRICS Cognitive Deficits (Composite Score)
Časové okno: 15 days
|
Correlations between changes in cognitive deficits (MATRICS composite score) and receptor binding will be examined.
|
15 days
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Abnormal Involuntary Movement Scale (AIMS) Score
Časové okno: 15 days
|
Correlations between changes in extrapyramidal side effect scores (AIMS) and receptor binding will be examined.
|
15 days
|
|
Simpson-Angus Scale (SAS) Score
Časové okno: 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
Časové okno: 15 days
|
Correlations between changes in extrapyramidal side effect scores (BARS) and receptor binding will be examined.
|
15 days
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. prosince 2026
Primární dokončení (Odhadovaný)
30. srpna 2030
Dokončení studie (Odhadovaný)
30. listopadu 2030
Termíny zápisu do studia
První předloženo
11. července 2026
První předloženo, které splnilo kritéria kontroly kvality
15. července 2026
První zveřejněno (Aktuální)
20. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
20. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
15. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NYSPI2026-31
- 1R01MH139651-01A1 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Data will be shared via the NIH data archive.
Časový rámec sdílení IPD
Data will be shared after the study has been completed, as per NIH guidelines.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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