NCT05435300Active, not recruiting
Does tDCS Change Synaptic Density in the Brains of Patients With Schizophrenia
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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 novel positron emission tomography (PET) radiotracer \[18F\]SDM-8, which is currently the best-in-class method to quantify synaptic density in humans. This will be a companion study to a parent study by our group examining the effects of tDCS on treatment adherence in schizophrenia (REB #103-2018).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 23 Jun 2022
- Start date
- 17 Sept 2021
- Primary completion date
- Sept 2026
- Lead sponsor
- Centre for Addiction and Mental Health
- Diseases
- Schizophrenia
- NCT number
- NCT05435300
What you commit to
- Study type: Observational
- Planned participants: 20
- From 17 Sept 2021 to the primary completion date, Sept 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 or any concomitant major medical or neurological illness, including a history of seizures
- 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)
- 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
Other illness
- Formal thought disorder rating ≥3 on the Positive and Negative Syndrome Scale (PANSS) P2 conceptual disorganization item
- Disorders of coagulation or taking anticoagulant medication
Other
- 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
- Acute suicidal or homicidal ideation
- DSM-V substance dependence (except caffeine, nicotine, and cannabis/marijuana) within 1 month of entering the study
- 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
- Having completed multiple PET scans in the past, such that participation in this study would cause participant to exceed lifetime limit (8 PET scans)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Addiction and Mental Health Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.