SchizophreniaNCT03999190
Imaging Dopamine D2 Agonist Binding Sites in Schizophrenia
An observational study of Schizophrenia, run by NYU Langone Health at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- NPA radiotracer, Raclopride radiotracer and Dextroamphetamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2019to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: SCHIZOPHRENIA patiens 18-35; Healthy Controls 18-35
Who may be able to join
- HEALTHY CONTROLS
- Males or females between 18 and 35 years old (History)
- 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))
- 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)
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- Medically Healthy (History, EKG, physical, labs (detailed labs are listed under screening procedures))
- Weight between 44 and 115 kg (physical exam)
- 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)
- Males or females between 18 and 35 years old (History)
- Fulfill DSM-V criteria for schizophrenic illness, schizophreniform or schizoaffective disorder (History, SCID)
- 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)
- Medically Healthy (History, EKG, physical, labs (detailed labs are listed in screening procedures))
- Clinical Global Impression-Severity scale (CGI-S) less than or equal to 4 (moderately ill).
- 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)
- Weight between 44 and 115 kg (Physical exam)
- Baseline systolic BP of < 150 and > 100, diastolic BP < 90 and >60 and baseline HR less than 90 (Physical exam)
Who cannot join
- HEALTHY CONTROLS
- Pregnancy or lactation, lack of effective birth control during 15 days before the scans* (Blood or Urine pregnancy test, history)
- Presence or positive history of serious medical or neurological illness, including low hemoglobin and seizure history.
- (Medical and neurological history, EKG, blood tests)
- Any current use (within past month) of amphetamines, opiates, cocaine, sedative-hypnotics, ecstasy PCP.
- (History, urine toxicology)
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- Any use of cannabis beyond occasional use (i.e. more than 2 - 4 times per month) (History, saliva cannabis test)
- 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)
- 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)
- Medical history of chronic obstructive pulmonary disease or other chronic respiratory disorders (Medical history)
- 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)
- Positive Allen Test indicating lack of collateral flow to hand (Physical Exam)
- Subjects with family history of a psychotic disorder, drug and alcohol Abuse/Dependence in first-degree relatives. (History)
- SUBJECTS WITH SCHIZOPHRENIA Criteria (Assessment)
- DSM-V disorder other than schizophrenia, schizophreniform or schizoaffective disorder (History, SCID)
- Any current use (within past month) of amphetamines, opiates, cocaine, sedative-hypnotics, ecstasy PCP.
- (History, urine toxicology)
- Any use of cannabis beyond occasional use (i.e. more than 2 - 4 times per month) (History, saliva cannabis test)
- Antipsychotic medications in the last 3 weeks (6 months for depot medications) prior to the first PET scanning session.
- (History)
- Pregnancy or lactation, lack of effective birth control - OCP are allowed. (Pregnancy test, history)
- 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)
- Lack of capacity to give informed consent (Interview)
- History of significant violent or suicidal behavior (Interview and review of records)
- 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)
- 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)
- Medical history of chronic obstructive pulmonary disease or other chronic respiratory disorders (Medical history)
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Schizophrenia
- Being tested
- NPA radiotracer, Raclopride radiotracer, Dextroamphetamine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPA radiotracerDrug
[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).
Raclopride radiotracerDrug
[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).
DextroamphetamineDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 30 subjects with schizophrenia | Not described Receives: Drug: NPA radiotracer; Drug: Raclopride radiotracer; Drug: Dextroamphetamine | |
| 30 healthy controls | Not described Receives: Drug: NPA radiotracer; Drug: Raclopride radiotracer; Drug: Dextroamphetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
base line Binding Potential (BPND)
PET outcome measure of the density of "available" neuroreceptors and the affinity of a drug to that neuroreceptor.
Measured: 37 Days
percent change in BPND
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.
Measured: 37 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study startJul 2019 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Why it stopped: investigational radiotracer was not approved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Frankle, Principal investigator, New York Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999190
- Sponsor's protocol ID
- 18-01207
- Status last verified
- May 2020
- First submitted
- 11 Jun 2019
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Dopamine D2 Agonist Binding Sites in Schizophrenia
- ClinicalTrials.gov ID
- NCT03999190
- Acronym / sponsor ID
- 18-01207
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: investigational radiotracer was not approved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 subjects with schizophrenia | – | Drug: NPA radiotracer, Drug: Raclopride radiotracer, Drug: Dextroamphetamine |
| 30 healthy controls | – | Drug: NPA radiotracer, Drug: Raclopride radiotracer, Drug: Dextroamphetamine |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- SCHIZOPHRENIA patiens 18-35; Healthy Controls 18-35
Key inclusion criteria (19 listed)
- HEALTHY CONTROLS
- (History, SCID-NP (non-patient version))
- (Urine toxicology)
- SUBJECTS WITH SCHIZOPHRENIA Criteria (Assessment)
- (Urine toxicology)
Key exclusion criteria (33 listed)
- HEALTHY CONTROLS
- (Medical and neurological history, EKG, blood tests)
- (History, urine toxicology)
- (Interview and history)
- (Interview and history)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPA radiotracer[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). | Drug | 30 healthy controls, 30 subjects with schizophrenia |
| Raclopride radiotracer[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). | Drug | 30 healthy controls, 30 subjects with schizophrenia |
| DextroamphetamineDextroamphetamine, 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). | Drug | 30 healthy controls, 30 subjects with schizophrenia |
Primary outcome
base line Binding Potential (BPND)
Time frame: 37 Days
PET outcome measure of the density of "available" neuroreceptors and the affinity of a drug to that neuroreceptor.
percent change in BPND
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Frankle principal investigator
New York Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
base line Binding Potential (BPND) (time frame: 37 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020; AzTrials last refreshed its copy on 30 Oct 2026.