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

Primary Purpose

Schizophrenia, Bipolar Disorder

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[11C]DPA-713
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  • 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.

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Patients with Schizophrenia Disorder

Patients with Bipolar Disorder

Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PET Imaging of microglial activation
To evaluate changes in activation of microglia in patients with acute schizophrenia and bipolar disorder relative to controls

Full Information

First Posted
August 15, 2017
Last Updated
September 8, 2020
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03257592
Brief Title
Positron Emission Tomography (PET) Imaging of Glial Activation in Psychotic Disease States
Official Title
PET Imaging of Glial Activation in Psychotic Disease States
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with Schizophrenia Disorder
Arm Type
Experimental
Arm Description
Patients with Schizophrenia Disorder will be imaged with [11C] DPA-713
Arm Title
Patients with Bipolar Disorder
Arm Type
Experimental
Arm Description
Patients with Bipolar Disorder will be imaged with [11C] DPA-713
Arm Title
Control
Arm Type
Experimental
Arm Description
Normal volunteers will be imaged with [11C] DPA-713
Intervention Type
Drug
Intervention Name(s)
[11C]DPA-713
Intervention Description
[11C]DPA-713 PET imaging
Primary Outcome Measure Information:
Title
Sensitivity and Specificity of ([11C]DPA)-713 PET brain imaging in patients with recent onset schizophrenia and in patients with recent onset of mania
Description
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 Outcome Measure Information:
Title
PET Imaging of microglial activation
Description
To evaluate changes in activation of microglia in patients with acute schizophrenia and bipolar disorder relative to controls
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Pomper, MD,PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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

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