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PET Imaging for Schizophrenia
Phase 1
Recruiting
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60-74 days
Awards & highlights
Study Summary
This trial will use brain imaging to study how neurotransmitters & receptors in schizophrenia differ from healthy brains.
Who is the study for?
This trial is for adults aged 18-55 with schizophrenia, including those experiencing acute psychotic episodes. Participants can be smokers but must abstain from tobacco/nicotine products for at least 3 hours before PET scans. Healthy volunteers of the same age range and specific ethnicities (Black/African-American or non-Hispanic White/Caucasian) are also eligible if they pass medical assessments.Check my eligibility
What is being tested?
The study uses PET scans with [18F]AZAN and [18F]ASEM tracers to investigate brain chemistry in people with schizophrenia versus healthy controls. It aims to understand neurotransmitter and receptor function using advanced imaging techniques alongside MRI.See study design
What are the potential side effects?
While the document does not specify side effects, typical risks associated with PET scans may include discomfort from lying still during the scan, allergic reactions to tracers, or exposure to low levels of radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60-74 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60-74 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Receptor binding of [18F] ASEM-PET to nicotinic brain receptors (α7-nAChRs) in adults ages 18-55 year with SCZ vs. matched controls.
Receptor binding of [18F]AZAN to α4β2 nicotinic acetylcholine receptors (α4β2-nAChR) in adults ages 18-55 years with SCZ vs. matched controls.
Nicotinic Agonists
+7 moreSecondary outcome measures
Relationship between the single nucleotide polymorphism (SNP) CHRNA7 rs3087454 and race in SCZ vs. matched controls.
Relationship between α4β2/α7-nAChR VT and tobacco use disorder in SCZ patients who are smokers vs. non-smoker SCZ patients treated with olanzapine.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Schizophrenia (olanz)Experimental Treatment2 Interventions
Visit 3: (ASEM/AZAN) Blood draw for DNA, PET scan/art line Visit 3: (ASEM only) Blood draw for DNA, PET scan/art line Visit 4: (ASEM only) PET scan/art line 2-wk Titration, 3-wk steady state
Group II: Schizophrenia (no med)Experimental Treatment2 Interventions
Visit 3: (ASEM/AZAN) Blood draw for DNA, PET scan/art line Visit 3: (ASEM only) Blood draw for DNA, PET scan/art line Visit 4: (ASEM only) PET scan/art line 2-wk Titration, 3-wk steady state
Group III: Schizophrenia (ari, brex, risp)Experimental Treatment2 Interventions
Visit 3: (ASEM/AZAN) Blood draw for DNA, PET scan/art line Visit 3: (ASEM only) Blood draw for DNA, PET scan/art line Visit 4: (ASEM only) PET scan/art line
Group IV: Healthy VolunteersExperimental Treatment2 Interventions
Visit 3: (ASEM/AZAN) Blood draw for DNA, PET scan/art line Visit 3: (ASEM only) Blood draw for DNA, PET scan/art line Visit 4: (ASEM only) PET scan/art line
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,575 Total Patients Enrolled
16 Trials studying Schizophrenia
945 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I use medication or herbal remedies that I can't stop for 14 days or 5 half-lives before a PET scan.A specialist confirmed I have good veins for procedures.I do not have any severe mental health or systemic diseases.My doctor is concerned about my heart health or blood tests due to my schizophrenia.My MRI shows significant abnormalities due to my schizophrenia.I am between 18 and 55 years old.I am taking medication for nausea or to stop smoking.I am on antipsychotics for schizophrenia, but not taking haloperidol.I am willing to not use tobacco or nicotine products for 3 hours before PET scans.I have schizophrenia and am only taking olanzapine.I am between 18 and 55 years old and have schizophrenia.I am not taking medication that affects brain scans, like certain nausea meds, nicotine, or memory drugs.I am currently being treated with clozapine for schizophrenia.I have schizophrenia and have been on a stable dose of antipsychotics like risperidone or aripiprazole for 3 months.I am not currently using medications that affect brain imaging results.I have been diagnosed with schizophrenia or am experiencing severe psychotic symptoms.I have never had a severe head injury, stroke, seizure (except childhood febrile seizure), or migraines.I have not been in a drug/device trial other than this one in the last 30 days.I have schizophrenia and a history of significant head injury, stroke, seizures (except fever-related in childhood), or migraines.
Research Study Groups:
This trial has the following groups:- Group 1: Schizophrenia (olanz)
- Group 2: Schizophrenia (no med)
- Group 3: Healthy Volunteers
- Group 4: Schizophrenia (ari, brex, risp)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial enumerate individuals aged 55 and above?
"This research venture is searching for volunteers between 18 and 55 years of age."
Answered by AI
Is it possible for me to join this experiment?
"Eligibility for this clinical trial mandates that participants suffer from schizophrenia and be aged between 18 to 55. Approximately 120 individuals will be chosen in total."
Answered by AI
Are there any contraindications to utilizing olanzapine for Schizophrenia?
"With a score of 1, our team at Power has assessed that the safety profile for olanzapine in regards to treating schizophrenia is relatively unknown due to this being an early-phase trial."
Answered by AI
Is this research endeavor actively enrolling participants?
"According to the information hosted on clinicaltrials.gov, this study is recruiting participants. The research was initially posted in August 18th 2022 and most recently updated on May 1st 2023."
Answered by AI
How many participants is the research team recruiting for this investigation?
"Affirmative, the clinicaltrials.gov database shows that this research project is presently recruiting patients; it was first posted on August 18th 2022 and most recently updated on May 1st 2023. A total of 120 individuals are sought from one location."
Answered by AI
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