Investigating the Muscarinic System in Schizophrenia Using Positron Emission Tomography (NCT06278246) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Investigating the Muscarinic System in Schizophrenia Using Positron Emission Tomography
Canada58 participantsStarted 2024-03-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age of 18 years and older
✓. Willing to consent to study procedures
✓. 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.
✓. Absence of history of psychiatric illness using the SCID-5
Exclusion criteria
✕. DSM-V diagnosis of schizoaffective disorder or psychosis not otherwise specified.
✕. 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.
What they're measuring
1
M4 receptor expression
Timeframe: At baseline
2
Clinical Data Statistical Analysis
Timeframe: At baseline and 6 week Follow-up after antipsychotic trial
✕. 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.
✕. Pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or any other conditions that would preclude the MRI scan
✕. Pregnancy (Note: Females up to age 65 must have negative urine pregnancy test at screening), or breastfeeding.