Investigating the Muscarinic System in Schizophrenia Using Positron Emission Tomography
NCT ID: NCT06278246
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
58 participants
OBSERVATIONAL
2024-03-11
2026-03-31
Brief Summary
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Detailed Description
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Participants who meet the inclusion and exclusion criteria at screening visit (visit 1) will be enrolled into the study. All participants will undergo a PET scan with the novel tracer \[11C\]MK-6884 to examine its binding with M4R. The third visit will consist of a MRI scan and cognitive assessments. Participants with schizophrenia will have visit four, which occurs 6 weeks after the first antipsychotic trial, initiated by their treating physician. If the treating physician starts a second antipsychotic trial, then a visit five occurs 6 weeks after the second trial. Both visits four and five involve clinical and cognitive assessments.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with Schizophrenia
Antipsychotic-free patients with schizophrenia or schizophreniform disorder
PET Scan
PET scan using the novel \[11C\]MK-6884 tracer to measure M4R during the antipsychotic-free state
Healthy Controls
Healthy controls matched for age, sex, cannabis, and nicotine consumption to the 29 patients
PET Scan
PET scan using the novel \[11C\]MK-6884 tracer to measure M4R during the antipsychotic-free state
Interventions
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PET Scan
PET scan using the novel \[11C\]MK-6884 tracer to measure M4R during the antipsychotic-free state
Eligibility Criteria
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Inclusion Criteria
1. Age of 18 years and older
2. Willing to consent to study procedures
Criteria for Patients with Schizophrenia:
1. Inpatients or outpatients ≥18 years of age.
2. DSM-V diagnosis of schizophrenia or schizophreniform disorder confirmed using SCID-5.
3. Capable of consenting to participate in the research study (MacCAT).
4. No exposure to long-acting antipsychotics in the past 6 months and oral antipsychotic-free for at least 2-weeks
5. Deemed suitable to receive first-line antipsychotic treatment as standard of care by the treating physician.
Criteria for Healthy Controls:
1. Absence of history of psychiatric illness using the SCID-5
2. Do not have any first-degree family members with a primary psychotic disorder.
3. Are willing to attend appointments reliably.
4. Are capable of providing consent
Exclusion Criteria
1. DSM-V diagnosis of schizoaffective disorder or psychosis not otherwise specified.
2. Unstable medical illness or any concomitant major medical or neurological illness, including a history of seizures and traumatic head injury resulting in a loss of consciousness \> 30 minutes that required medical attention.
3. Acute suicidal and/or homicidal ideation.
4. DSM-V substance use disorder (except caffeine and nicotine) within one month prior to study entry.
5. Positive urine drug screen for drugs of abuse at the screening visit (excluding cannabis and/or benzodiazepines).
6. Reporting the chronic use of medication with muscarinic mechanism of action.
7. Pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or any other conditions that would preclude the MRI scan
8. Pregnancy (Note: Females up to age 65 must have negative urine pregnancy test at screening), or breastfeeding.
9. If participation in the study would expose participants to more than the annual radiation dose limit (20 mSv) for human subjects participating in research studies, or if the potential participant already underwent a number of PET scans that, including the PET scans under this protocol, will bring the total to more than 8 PET scans /lifetime. For example, participants known to have already been exposed to radiation through X-rays, CT-scans, or other nuclear medicine procedures during the last year may have already surpassed, or will surpass via study participation, the annual radiation dose limit and thus be excluded.
10. Clinically significant claustrophobia
11. Size of head, neck, and body being unable to fit MRI or PET scanners (e.g. body weight of 350 pounds).
12. Blood or coagulation disorders, or taking anticoagulant medication (not antiplatelet).
Patients with Schizophrenia will also be excluded if they meet ANY of the criteria listed below:
1. Refusal to give consent to investigator to communicate with treating physician for entire duration of the study.
2. Previous clozapine treatment.
18 Years
ALL
Yes
Sponsors
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Centre for Addiction and Mental Health
OTHER
Responsible Party
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Principal Investigators
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Ariel Graff, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health
Locations
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Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
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Related Links
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Description The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.
Other Identifiers
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050/2021
Identifier Type: -
Identifier Source: org_study_id
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