SchizophreniaPhase 1NCT03257592
Positron Emission Tomography (PET) Imaging of Glial Activation in Psychotic Disease States
A Phase 1 study testing [11C]DPA-713 in people with Schizophrenia and Bipolar Disorder, run by Johns Hopkins University at 1 site in United States.
Trial summary
Many neurological diseases, including AIDS dementia, Alzheimer's disease and schizophrenia, involve an inflammatory component thought to specifically involve glial cell activation. The Investigators has been concerned with the development of tools for noninvasive imaging of inflammatory processes in psychotic disease. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- What is being tested?
- [11C]DPA-713
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Apr 2018
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers 18-65 years of age
- Patients diagnosed with recent onset schizophrenia (within 5 years of onset), 18-65 years of age
- Patients diagnosed with recent onset bipolar disorder (within 5 years of onset of first mania), 18-65 years of age
- screening laboratory tests will be obtained for subjects within a 10 day period prior to the PET study and the results must be within normal limits for gender and age. These tests will be repeated with a 7-day window following the PET study
- EKG conducted within 10 day period prior to the PET study. The EKG will be repeated within 7 days following the study.
- Subject agrees to return to the Hospital for a follow-up EKG and laboratory testing of blood and urine.
- For females of childbearing potential, negative serum pregnancy test within a 10 day period prior to PET study.
Who cannot join
- history of recent nosocomial infection,
- history of chronic neurological disorder, such as multiple sclerosis or epilepsy, or structural,central nervous system (CNS) abnormality such as stroke or arteriovenous malformation,
- history of head injury with loss of consciousness > 1 hour,
- history of active substance abuse as defined by substance abuse including alcohol abuse over the 6 months prior to the study,
- dependence on benzodiazepine medication
- contraindications to MRI scanning to include pacemakers, metallic implants/prosthesis or prohibitive claustrophobia, etc.
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- contraindications to PET scanning to include pregnancy, etc. For females of childbearing potential, negative serum pregnancy test less than 10 days prior to PET study
- ECG demonstrating the patient is not in a sinus rhythm or is having acute ischemia.
- any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PET Imaging of Glial Activation in Psychotic Disease States
Many neurological diseases, including AIDS dementia, Alzheimer's disease and schizophrenia, involve an inflammatory component thought to specifically involve glial cell activation. The Investigators has been concerned with the development of tools for noninvasive imaging of inflammatory processes in psychotic disease. Here, the investigators aim to use PET-based neuroimaging with carbon-11 N,N-diethyl-2-(4-methoxyphenyl)-5,7-dimethylpyrazolo[1,5-a]pyrimidine-3-acetamide, ([11C]DPA)-713 to quantify regional distribution of translocator protein (TSPO), a putative marker of inflammation, in the brains of patients with schizophrenia and bipolar disorder, type I. The investigators will focus on patients in the early stages of disease (within first five years of onset of schizophrenia diagnosis and within first five years of first manis, respectively) to minimize the confounds of age-, chronic illness-, and medication- effects on our results.
- Conditions
- Schizophrenia, Bipolar Disorder
- Being tested
- [11C]DPA-713
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]DPA-713Drug
[11C]DPA-713 PET imaging
| Study group | Role | What they receive |
|---|---|---|
| Patients with Schizophrenia Disorder | Experimental | Patients with Schizophrenia Disorder will be imaged with [11C] DPA-713 Receives: Drug: [11C]DPA-713 |
| Patients with Bipolar Disorder | Experimental | Patients with Bipolar Disorder will be imaged with [11C] DPA-713 Receives: Drug: [11C]DPA-713 |
| Control | Experimental | Normal volunteers will be imaged with [11C] DPA-713 Receives: Drug: [11C]DPA-713 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of ([11C]DPA)-713 PET brain imaging in patients with recent onset schizophrenia and in patients with recent onset of mania
To determine regional brain uptake of this radioligand in patients with recent onset schizophrenia and in patients with recent onset of mania
Measured: within five years of onset of schizophrenia or within five years of first manic episode
Secondary outcomes (1)
PET Imaging of microglial activation
To evaluate changes in activation of microglia in patients with acute schizophrenia and bipolar disorder relative to controls
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study startAug 2010
- Primary completionApr 2018
- Study completionApr 2018
Why it stopped: Lack of funding
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 Johns Hopkins UniversityThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Pomper, MD,PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257592
- Sponsor's protocol ID
- NA_00037683
- Status last verified
- Oct 2018
- First submitted
- 15 Aug 2017
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of Glial Activation in Psychotic Disease States
- ClinicalTrials.gov ID
- NCT03257592
- Acronym / sponsor ID
- NA_00037683
- Conditions
- Schizophrenia, Bipolar Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 22 Aug 2017 (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.
Many neurological diseases, including AIDS dementia, Alzheimer's disease and schizophrenia, involve an inflammatory component thought to specifically involve glial cell activation. The Investigators has been concerned with the development of tools for noninvasive imaging of inflammatory processes in psychotic disease. Here, the investigators aim to use PET-based neuroimaging with carbon-11 N,N-diethyl-2-(4-methoxyphenyl)-5,7-dimethylpyrazolo[1,5-a]pyrimidine-3-acetamide, ([11C]DPA)-713 to quantify regional distribution of translocator protein (TSPO), a putative marker of inflammation, in the brains of patients with schizophrenia and bipolar disorder, type I. The investigators will focus on patients in the early stages of disease (within first five years of onset of schizophrenia diagnosis and within first five years of first manis, respectively) to minimize the confounds of age-, chronic illness-, and medication- effects on our results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Schizophrenia Disorder | Experimental | Drug: [11C]DPA-713Patients with Schizophrenia Disorder will be imaged with [11C] DPA-713 |
| Patients with Bipolar Disorder | Experimental | Drug: [11C]DPA-713Patients with Bipolar Disorder will be imaged with [11C] DPA-713 |
| Control | Experimental | Drug: [11C]DPA-713Normal volunteers will be imaged with [11C] DPA-713 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- healthy volunteers 18-65 years of age
- Patients diagnosed with recent onset schizophrenia (within 5 years of onset), 18-65 years of age
- Patients diagnosed with recent onset bipolar disorder (within 5 years of onset of first mania), 18-65 years of age
- screening laboratory tests will be obtained for subjects within a 10 day period prior to the PET study and the results must be within normal limits for gender and age. These tests will be repeated with a 7-day window following the PET study
- EKG conducted within 10 day period prior to the PET study. The EKG will be repeated within 7 days following the study.
Key exclusion criteria (9 listed)
- history of recent nosocomial infection,
- history of chronic neurological disorder, such as multiple sclerosis or epilepsy, or structural,central nervous system (CNS) abnormality such as stroke or arteriovenous malformation,
- history of head injury with loss of consciousness > 1 hour,
- history of active substance abuse as defined by substance abuse including alcohol abuse over the 6 months prior to the study,
- dependence on benzodiazepine medication
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 |
|---|---|---|
| [11C]DPA-713[11C]DPA-713 PET imaging | Drug | Control, Patients with Bipolar Disorder, Patients with Schizophrenia Disorder |
Primary outcome
Sensitivity and Specificity of ([11C]DPA)-713 PET brain imaging in patients with recent onset schizophrenia and in patients with recent onset of mania
Time frame: within five years of onset of schizophrenia or within five years of first manic episode
To determine regional brain uptake of this radioligand in patients with recent onset schizophrenia and in patients with recent onset of mania
1 secondary outcome
PET Imaging of microglial activation
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 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.
Martin Pomper, MD,PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [11C]DPA-713 in people with Schizophrenia and Bipolar Disorder, run by Johns Hopkins University 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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 10 Sep 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
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?
Sensitivity and Specificity of ([11C]DPA)-713 PET brain imaging in patients with recent onset schizophrenia and in patients with recent onset of mania (time frame: within five years of onset of schizophrenia or within five years of first manic episode). 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 10 Sep 2020.