The Effects of Non-invasive Brain Stimulation on Treatment Adherence in Schizophrenia
Recruiting · NCT04033679 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre for Addiction and Mental Health
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What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Centre for Addiction and Mental Health - Toronto, Ontario, Canada