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TerminatedNCT03257592Updated Sep 10, 2020

Positron Emission Tomography (PET) Imaging of Glial Activation in Psychotic Disease States

A Phase 1 interventional study of [11C]DPA-713 in Schizophrenia and Bipolar Disorder, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-10.

Sponsored by Johns Hopkins University · Phase 1, Interventional, and Diagnostic

Why this study was terminated
Lack of funding
Phase
Phase 1
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Schizophrenia
  • Bipolar Disorder
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
04

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Patients with Schizophrenia Disorder

    Patients with Schizophrenia Disorder will be imaged with \[11C\] DPA-713

    Drug: [11C]DPA-713

  • Experimental
    Patients with Bipolar Disorder

    Patients with Bipolar Disorder will be imaged with \[11C\] DPA-713

    Drug: [11C]DPA-713

  • Experimental
    Control

    Normal volunteers will be imaged with \[11C\] DPA-713

    Drug: [11C]DPA-713

Interventions

  • Drug[11C]DPA-713

    \[11C\]DPA-713 PET imaging

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 5 years

06

Study locations

1 site
  • Johns Hopkins University
    Baltimore, Maryland 21287, United States
07

Registry details

Key details

Study ID
NCT03257592
Lead sponsor
Johns Hopkins University
Responsible party
Sponsor
First posted
Aug 22, 2017
Start date
Aug 2010
Primary completion
Apr 2018
Completion
Apr 2018
Last update
Sep 10, 2020

Study contacts

Martin Pomper, MD,PhD
principal investigator · Professor

Oversight

Data monitoring committee
No
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