RecruitingNCT05435300

Does tDCS Change Synaptic Density in the Brains of Patients With Schizophrenia


Sponsor

Centre for Addiction and Mental Health

Enrollment

20 participants

Start Date

Sep 17, 2021

Study Type

OBSERVATIONAL

Conditions

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 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).


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria15

  • 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
  • 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)

Interventions

OTHERPET Scan

Participants will undergo two PET scans throughout the study.


Locations(1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05435300


Related Trials