The Effects of Non-invasive Brain Stimulation on Treatment Adherence in Schizophrenia

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    106
  • sponsor
    Centre for Addiction and Mental Health
Updated on 14 June 2022

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 adherence in patients with schizophrenia (SCZ). The investigators hypothesize that 20 sessions of tDCS will improve medication nonadherence in patients with SCZ.

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 nonadherence in patients with SCZ. Participants will be randomized to receive either active or sham tDCS. tDCS will be administered twice-daily for 10 days (20 sessions) excluding weekends. Brain scans will be performed before and after 10 days of tDCS. Antipsychotic drug adherence will be assessed based primarily on pill-count, and secondarily, plasma level concentrations and clinician-judgement.

Details
Condition Schizophrenia;Schizoaffective
Treatment active tDCS, Sham tDCS
Clinical Study IdentifierNCT04033679
SponsorCentre for Addiction and Mental Health
Last Modified on14 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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