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NCT06278246Active, not recruiting

Investigating the Muscarinic System in Schizophrenia Using Positron Emission Tomography

The Muscarinic Hypothesis of Schizophrenia: an [11C]MK-6884 PET Study Study Protocol

Source: ClinicalTrials.gov · Last updated 28 Mar 2025

Brief summary (registry, in English)

Within the schizophrenia population, there are individuals that respond to first-line antipsychotic treatments while others do not. The availability of muscarinic M4 subtype receptors (M4R) may play a role as to whether a person with schizophrenia is responsive to first-line antipsychotics or not. The goal of this observational study is to compare the availability of M4R in antipsychotic-free patients with schizophrenia and matched healthy controls. In addition, M4R availability in schizophrenia patients will be examined in relation to response to first line antipsychotics and clinical and cognitive measures. This study may help better understand antipsychotic resistance in schizophrenia and lead to the development of new treatment options, particularly for cognitive deficits and negative symptoms.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
58 (estimated)
First submitted
15 Feb 2024
Start date
11 Mar 2024
Primary completion date
Mar 2026
Lead sponsor
Centre for Addiction and Mental Health
NCT number
NCT06278246

What you commit to

  • Study type: Observational
  • Planned participants: 58
  • From 11 Mar 2024 to the primary completion date, Mar 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • DSM-V substance use disorder (except caffeine and nicotine) within one month prior to study entry.
  • Positive urine drug screen for drugs of abuse at the screening visit (excluding cannabis and/or benzodiazepines).
  • Reporting the chronic use of medication with muscarinic mechanism of action.
  • 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.
  • Previous clozapine treatment.

Other illness

  • DSM-V diagnosis of schizoaffective disorder or psychosis not otherwise specified.
  • Pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or any other conditions that would preclude the MRI scan
  • 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:

Age

  • Pregnancy (Note: Females up to age 65 must have negative urine pregnancy test at screening), or breastfeeding.

Other

  • Participants will be excluded if they meet ANY of the criteria listed below:
  • Acute suicidal and/or homicidal ideation.
  • Clinically significant claustrophobia
  • Size of head, neck, and body being unable to fit MRI or PET scanners (e.g. body weight of 350 pounds).
  • Refusal to give consent to investigator to communicate with treating physician for entire duration of the study.

Who the study is looking for

  • Criteria for both Patients with Schizophrenia and Healthy Controls:
  • Age of 18 years and older
  • Willing to consent to study procedures
    • Criteria for Patients with Schizophrenia:
  • Inpatients or outpatients ≥18 years of age.
  • DSM-V diagnosis of schizophrenia or schizophreniform disorder confirmed using SCID-5.
  • Capable of consenting to participate in the research study (MacCAT).
  • No exposure to long-acting antipsychotics in the past 6 months and oral antipsychotic-free for at least 2-weeks
  • Deemed suitable to receive first-line antipsychotic treatment as standard of care by the treating physician.
    • Criteria for Healthy Controls:
  • Absence of history of psychiatric illness using the SCID-5
  • Do not have any first-degree family members with a primary psychotic disorder.
  • Are willing to attend appointments reliably.
  • Are capable of providing consent

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre for Addiction and Mental Health
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.