Does tDCS Change Synaptic Density in the Brains of Patients With Schizophrenia
NCT ID: NCT05435300
Last Updated: 2025-09-23
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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RECRUITING
20 participants
OBSERVATIONAL
2021-09-17
2026-03-31
Brief Summary
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Detailed Description
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PET scans will be offered to participants that meet the inclusion and exclusion criteria at the initial screening visit. Participants will be scanned with the novel PET tracer \[18F\]SDM-8 to quantify synaptic density levels. PET scans will be timed to coincide to the two time-points, before and after 2-weeks of tDCS treatment that is completed under the parent study protocol (REB #103-2018). Clinical assessments will be done at the same time.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Schizophrenia/Schizoaffective Disorder
Participants with Schizophrenia/Schizoaffective Disorder and currently enrolled in the tDCS-adherence parent study (REB# 103-2018).
PET Scan
Participants will undergo two PET scans throughout the study.
Interventions
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PET Scan
Participants will undergo two PET scans throughout the study.
Eligibility Criteria
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Inclusion Criteria
2. Inpatients or outpatients ≥18 years of age
3. DSM-V diagnosis of schizophrenia or schizoaffective disorder
4. Capable of consenting to participate in the research study
5. 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 Criteria
2. Unstable medical or any concomitant major medical or neurological illness, including a history of seizures
3. Acute suicidal or homicidal ideation
4. Formal thought disorder rating ≥3 on the Positive and Negative Syndrome Scale (PANSS) P2 conceptual disorganization item
5. DSM-V substance dependence (except caffeine, nicotine, and cannabis/marijuana) within 1 month of entering the study
6. Positive urine drug screen except for cannabis/marijuana at the screening visit
7. Metal implants or pacemaker precluding an MRI scan or other contraindications to MRI (e.g., claustrophobia)
8. Pregnancy
9. Score \<32 on the Wide Range Achievement Test-III
1. Unwilling or incapable to consent to the study based on the MacArthur Test of Competence
2. Exposure to long-acting injectable antipsychotics in the last 6 months
3. Exceeding allowed annual radiation exposure levels (20 mSv), as outlined by our PET Centre guidelines
4. Receiving treatment with medications such as levetiracetam that blocks SV2a binding
5. Disorders of coagulation or taking anticoagulant medication
6. Having completed multiple PET scans in the past, such that participation in this study would cause participant to exceed lifetime limit (8 PET scans)
18 Years
ALL
No
Sponsors
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Centre for Addiction and Mental Health
OTHER
Responsible Party
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Principal Investigators
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Philip Gerretsen, 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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Central Contacts
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Facility Contacts
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Related Links
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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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118/2020
Identifier Type: -
Identifier Source: org_study_id
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