Status:
RECRUITING
Does tDCS Change Synaptic Density in the Brains of Patients With Schizophrenia
Lead Sponsor:
Centre for Addiction and Mental Health
Conditions:
Schizophrenia
Schizoaffective
Eligibility:
All Genders
18+ years
Brief Summary
This study will examine changes in synaptic density with transcranial direct current stimulation (tDCS) in the brains of patients with schizophrenia. Synaptic density levels will be measured using a n...
Detailed Description
The aim of our study is to examine if tDCS induces synaptic density changes in patients with schizophrenia using \[18F\]SDM-8. Our study will help elucidate the mechanism through which tDCS affects th...
Eligibility Criteria
Inclusion
- Enrolment in the tDCS-adherence parent study (REB# 103-2018). The parent study inclusion criteria are:
- Male or female participants of any race or ethnicity
- Inpatients or outpatients ≥18 years of age
- DSM-V diagnosis of schizophrenia or schizoaffective disorder
- Capable of consenting to participate in the research study
- On a stable dose of oral antipsychotic drug and other concomitant medications for at least 2 months, and unlikely to undergo changes in dose during the study.
Exclusion
- The exclusion criteria for this study will be the same as the parent study (REB 103-2018). The parent study exclusion criteria are:
- Unwilling or incapable to consent to the study based on the MacArthur Test of Competence
- Unstable medical or any concomitant major medical or neurological illness, including a history of seizures
- Acute suicidal or homicidal ideation
- Formal thought disorder rating ≥3 on the Positive and Negative Syndrome Scale (PANSS) P2 conceptual disorganization item
- DSM-V substance dependence (except caffeine, nicotine, and cannabis/marijuana) within 1 month of entering the study
- Positive urine drug screen except for cannabis/marijuana at the screening visit
- Metal implants or pacemaker precluding an MRI scan or other contraindications to MRI (e.g., claustrophobia)
- Pregnancy
- Score \<32 on the Wide Range Achievement Test-III
- Additional exclusion criteria for this companion study are:
- Unwilling or incapable to consent to the study based on the MacArthur Test of Competence
- Exposure to long-acting injectable antipsychotics in the last 6 months
- Exceeding allowed annual radiation exposure levels (20 mSv), as outlined by our PET Centre guidelines
- Receiving treatment with medications such as levetiracetam that blocks SV2a binding
- Disorders of coagulation or taking anticoagulant medication
- Having completed multiple PET scans in the past, such that participation in this study would cause participant to exceed lifetime limit (8 PET scans)
Key Trial Info
Start Date :
September 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05435300
Start Date
September 17 2021
End Date
March 31 2026
Last Update
September 23 2025
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8