Status:
RECRUITING
The Effects of Non-invasive Brain Stimulation on Treatment Adherence in Schizophrenia
Lead Sponsor:
Centre for Addiction and Mental Health
Conditions:
Schizophrenia;Schizoaffective
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study seeks to explore the effects of transcranial direct current stimulation (tDCS), a non-invasive method of brain stimulation, as an adjunctive treatment to improve antipsychotic medication ad...
Detailed Description
The proposed study will investigate the effects of adjunctive tDCS on antipsychotic medication adherence by targeting brain regions implicated in impaired insight, a primary contributor to medication ...
Eligibility Criteria
Inclusion
- Male or female participants of any race or ethnicity
- Inpatients or outpatients ≥18 years of age
- DSM-V diagnosis of SCZ or schizoaffective disorder
- Capable of consenting to participate in the research study
- On a stable dose of antipsychotic drug and other concomitant medications for at least 2 months, and unlikely to undergo changes in dose during the study
Exclusion
- 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 and nicotine) 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 (eg., claustrophobia)
- Pregnancy
- Score \< 32 on the Wide Range Achievement Test-III
- Substance misuse: In addition to impaired insight, substance misuse is one of the principle contributors to medication nonadherence. To minimize the possibility of its influence, participants with a DSM-V diagnosis of substance dependence within 1 month of entering the study or a positive urine drug test (except for cannabis/marijuana) at the screening visit will be excluded. Substance use and urine drug screens will be assessed at subsequent study visits.
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04033679
Start Date
August 15 2019
End Date
March 31 2026
Last Update
March 28 2025
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8