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

NCT ID: NCT03257592

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2018-04-30

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.

Conditions

Schizophrenia; Bipolar Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with Schizophrenia Disorder

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

Group Type: EXPERIMENTAL

[11C]DPA-713

Intervention Type: DRUG

\[11C\]DPA-713 PET imaging

Patients with Bipolar Disorder

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

Group Type: EXPERIMENTAL

[11C]DPA-713

Intervention Type: DRUG

\[11C\]DPA-713 PET imaging

Control

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

Group Type: EXPERIMENTAL

[11C]DPA-713

Intervention Type: DRUG

\[11C\]DPA-713 PET imaging

Interventions

[11C]DPA-713

\[11C\]DPA-713 PET imaging

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Pomper, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00037683

Identifier Type: -

Identifier Source: org_study_id