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

Phase 1

Terminated

• Conditions: Schizophrenia; Bipolar Disorder
• Interventions: Drug: [11C]DPA-713

• Registration Number: NCT03257592
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-22
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-10
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	[11C]DPA-713	Normal volunteers will be imaged with \[11C\] DPA-713
Patients with Bipolar Disorder	[11C]DPA-713	Patients with Bipolar Disorder will be imaged with \[11C\] DPA-713
Patients with Schizophrenia Disorder	[11C]DPA-713	Patients with Schizophrenia Disorder will be imaged with \[11C\] DPA-713

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of ([11C]DPA)-713 PET brain imaging in patients with recent onset schizophrenia and in patients with recent onset of mania	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

Secondary Outcome Measures

Name	Time	Method
PET Imaging of microglial activation	5 years	To evaluate changes in activation of microglia in patients with acute schizophrenia and bipolar disorder relative to controls

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States