이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Imaging Dopamine D2 Agonist Binding Sites in Schizophrenia

2020년 5월 27일 업데이트: NYU Langone Health
The goals of this study is to determine (1) if differences in D2/3 receptor affinity states exist between medication-free subjects with SCH (MF-S) compared with healthy controls (HC), (2) the degree to which pre- and post-synaptic factors contribute to increased striatal dopamine (DA) signaling in MF-S and (3) to test the hypotheses that optimal DA transmission in the dorsal caudate (DCA) is necessary for normal working memory (WM) function.

연구 개요

상세 설명

An antagonist ([11C]raclopride) and agonist ([11C]NPA) radiotracer will be used sequentially, in a counterbalanced design, to measure binding potential (BPND) under baseline conditions and 3-hours following oral administration of 0.5 mg/kg amphetamine in the same 30 MF-S and 30 HC. The main outcome measures will be baseline BPND and the percent change in BPND induced by amphetamine, denoted ∆BPND, in the subdivisions of the striatum. In addition, all subjects will undergo fMRI while performing a WM task concurrent with both the initial pre- and initial post-amphetamine PET scans to explore the relationship between DCA DA transmission and fMRI BOLD response in the dorsal lateral prefrontal cortex (DLPFC) during a WM task.

연구 유형

관찰

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • New York
      • New York, New York, 미국, 10016
        • NYU Langone Health

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

여성

샘플링 방법

비확률 샘플

연구 인구

SCHIZOPHRENIA patiens 18-35; Healthy Controls 18-35

설명

Inclusion Criteria:

  • HEALTHY CONTROLS

    1. Males or females between 18 and 35 years old (History)
    2. Absence of current (i.e. last six months) psychiatric conditions (including alcohol and drug abuse). Subjects with a history of a non-psychotic psychiatric disorder who have been asymptomatic and not taking medication for the past 6 months may be eligible.

      (History, SCID-NP (non-patient version))

    3. A negative urine toxicology with the exception of cannabis; in the case of a positive urine cannabis test a salivary cannabis test will be administered on the day of the PET scans to ensure subjects have not used within 24 - 48 hours.

      (Urine toxicology)

    4. Medically Healthy (History, EKG, physical, labs (detailed labs are listed under screening procedures))
    5. Weight between 44 and 115 kg (physical exam)
    6. Baseline systolic BP of < 150 and > 100, diastolic BP < 90 and >60 and baseline HR less than 90 (Physical exam)
  • SUBJECTS WITH SCHIZOPHRENIA Criteria (Assessment)

    1. Males or females between 18 and 35 years old (History)
    2. Fulfill DSM-V criteria for schizophrenic illness, schizophreniform or schizoaffective disorder (History, SCID)
    3. A negative urine toxicology with the exception of cannabis; in the case of a positive urine cannabis test a salivary cannabis test will be administered on the day of the PET scans to ensure subjects have not used within 24 - 48 hours.

      (Urine toxicology)

    4. Medically Healthy (History, EKG, physical, labs (detailed labs are listed in screening procedures))
    5. Clinical Global Impression-Severity scale (CGI-S) less than or equal to 4 (moderately ill).
    6. Off all medications for at least 1 week, does not wish to restart medications immediately and clinically stable while off medications. With the exception of lorazepam at a maximal dose of 2 mg QD, up to 24 h prior to the scans, and absence of injection of depot medication within the last 6 months (Interview and discussion with treating clinician)
    7. Weight between 44 and 115 kg (Physical exam)
    8. Baseline systolic BP of < 150 and > 100, diastolic BP < 90 and >60 and baseline HR less than 90 (Physical exam)

Exclusion Criteria:

  • HEALTHY CONTROLS

    1. Pregnancy or lactation, lack of effective birth control during 15 days before the scans* (Blood or Urine pregnancy test, history)
    2. Presence or positive history of serious medical or neurological illness, including low hemoglobin and seizure history.

      (Medical and neurological history, EKG, blood tests)

    3. Any current use (within past month) of amphetamines, opiates, cocaine, sedative-hypnotics, ecstasy PCP.

      (History, urine toxicology)

    4. Any use of cannabis beyond occasional use (i.e. more than 2 - 4 times per month) (History, saliva cannabis test)
    5. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan (but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant. Dental fillings do not present a risk for MRI), as determined in consultation with a neuroradiologist and according to the guidelines set forth in the following reference book commonly used by neuroradiologists: "Guide to MR procedures and metallic objects" Shellock, PhD, Lippincott Williams and Wilkins, NY 2001. If there is any doubt, subjects will be excluded.

      (Interview and history)

    6. Lifetime exposure to radiation in the workplace; or participation in research protocols involving exposure to radiation within the previous year such that the total cumulative annual radiation dose (i.e., from participation in the previous research studies and this study) would exceed the radiation dose limits specified in the FDA regulations at 21 CFR 361.1, Radioactive Drugs Considered Generally Safe and Effective (i.e. annual cumulative radiation dose limit = 5 rems to gonads, blood-forming organs, lens of eye, whole body; 15 rems to other organs).

      (Interview and history)

    7. Medical history of chronic obstructive pulmonary disease or other chronic respiratory disorders (Medical history)
    8. More than one risk factor for coronary artery disease (smoking, cholesterol > 240 mg/dl, sedentary lifestyle) baseline SBP > 140 of DBP> 90) (History, physical examination and blood chemistry)
    9. Positive Allen Test indicating lack of collateral flow to hand (Physical Exam)
    10. Subjects with family history of a psychotic disorder, drug and alcohol Abuse/Dependence in first-degree relatives. (History)
  • SUBJECTS WITH SCHIZOPHRENIA Criteria (Assessment)

    1. DSM-V disorder other than schizophrenia, schizophreniform or schizoaffective disorder (History, SCID)
    2. Any current use (within past month) of amphetamines, opiates, cocaine, sedative-hypnotics, ecstasy PCP.

      (History, urine toxicology)

    3. Any use of cannabis beyond occasional use (i.e. more than 2 - 4 times per month) (History, saliva cannabis test)
    4. Antipsychotic medications in the last 3 weeks (6 months for depot medications) prior to the first PET scanning session.

      (History)

    5. Pregnancy or lactation, lack of effective birth control - OCP are allowed. (Pregnancy test, history)
    6. Presence or positive history of severe medical or neurological illness or any cardiovascular disease, low hemoglobin, and seizure history.

      (Medical and neurological history, neurological exam, EKG, blood chemistry)

    7. Lack of capacity to give informed consent (Interview)
    8. History of significant violent or suicidal behavior (Interview and review of records)
    9. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan (but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant. Dental fillings do not present a risk for MRI), as determined in consultation with a neuroradiologist and according to the guidelines set forth in the following reference book commonly used by neuroradiologists: "Guide to MR procedures and metallic objects" Shellock, PhD, Lippincott Williams and Wilkins, NY 2001. If there is any doubt, subjects will be excluded.

      (Interview and history)

    10. Lifetime exposure to radiation in the workplace; or participation in research protocols involving exposure to radiation within the previous year such that the total cumulative annual radiation dose (i.e., from participation in the previous research studies and this study) would exceed the radiation dose limits specified in the FDA regulations at 21 CFR 361.1, Radioactive Drugs Considered Generally Safe and Effective (i.e. annual cumulative radiation dose limit = 5 rems to gonads, blood-forming organs, lens of eye, whole body; 15 rems to other organs).

      (Interview and history)

    11. Medical history of chronic obstructive pulmonary disease or other chronic respiratory disorders (Medical history)
    12. More than one risk factor for coronary artery disease (smoking, cholesterol > 240 mg/dl, sedentary lifestyle) baseline SBP > 140 of DBP> 90) (History, physical examination and blood chemistry)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
30개의 건강한 컨트롤

[11C]NPA radiotracer, 2 injection per subject

Antagonist ([11C]raclopride) and agonist ([11C]NPA) radiotracer will be used sequentially to measure binding potential (BPND) under baseline conditions and 3-hours following oral administration of 0.5 mg/kg amphetamine in the same 30 medication free subjects with schizophrenia (MF-S) and 30 healthy control subjects (HC).

[11C]raclopride radiotracer, 2 injections per subject

Antagonist ([11C]raclopride) and agonist ([11C]NPA) radiotracer will be used sequentially to measure binding potential (BPND) under baseline conditions and 3-hours following oral administration of 0.5 mg/kg amphetamine in the same 30 medication free subjects with schizophrenia (MF-S) and 30 healthy control subjects (HC).

Dextroamphetamine, one oral administration of 0.5 mg/kg per subject Antagonist ([11C]raclopride) and agonist ([11C]NPA) radiotracer will be used sequentially to measure binding potential (BPND) under baseline conditions and 3-hours following oral administration of 0.5 mg/kg amphetamine in the same 30 medication free subjects with schizophrenia (MF-S) and 30 healthy control subjects (HC).
30 subjects with schizophrenia

[11C]NPA radiotracer, 2 injection per subject

Antagonist ([11C]raclopride) and agonist ([11C]NPA) radiotracer will be used sequentially to measure binding potential (BPND) under baseline conditions and 3-hours following oral administration of 0.5 mg/kg amphetamine in the same 30 medication free subjects with schizophrenia (MF-S) and 30 healthy control subjects (HC).

[11C]raclopride radiotracer, 2 injections per subject

Antagonist ([11C]raclopride) and agonist ([11C]NPA) radiotracer will be used sequentially to measure binding potential (BPND) under baseline conditions and 3-hours following oral administration of 0.5 mg/kg amphetamine in the same 30 medication free subjects with schizophrenia (MF-S) and 30 healthy control subjects (HC).

Dextroamphetamine, one oral administration of 0.5 mg/kg per subject Antagonist ([11C]raclopride) and agonist ([11C]NPA) radiotracer will be used sequentially to measure binding potential (BPND) under baseline conditions and 3-hours following oral administration of 0.5 mg/kg amphetamine in the same 30 medication free subjects with schizophrenia (MF-S) and 30 healthy control subjects (HC).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
base line Binding Potential (BPND)
기간: 37 Days
PET outcome measure of the density of "available" neuroreceptors and the affinity of a drug to that neuroreceptor.
37 Days
percent change in BPND
기간: 37 Days
Difference between BPND measured in the post-amphetamine condition (BPND AMPH) and BPND measured in the baseline condition (BPND BASE) expressed as a percentage of BPND BASE: BPND = 100 * (BPND AMPH - BPND BASE)/BPND BASE.
37 Days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: William Frankle, New York Langone Health

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2019년 7월 1일

기본 완료 (예상)

2025년 7월 1일

연구 완료 (예상)

2025년 7월 1일

연구 등록 날짜

최초 제출

2019년 6월 11일

QC 기준을 충족하는 최초 제출

2019년 6월 25일

처음 게시됨 (실제)

2019년 6월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 5월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 5월 27일

마지막으로 확인됨

2020년 5월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

NPA radiotracer에 대한 임상 시험

구독하다