The Effects of Non-invasive Brain Stimulation on Treatment Adherence in Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active TDCS, Sham TDCS.
- Who it may be relevant to
- Registry conditions: Schizophrenia;Schizoaffective. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effects of Adjunctive Transcranial Direct Current Stimulation on Treatment Adherence in Schizophrenia
Overview
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.
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 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.
Interventions
- Other Active TDCS
Participants will receive active TDCS stimulation. - Other Sham TDCS
Participants will receive sham TDCS stimulation.
Primary outcome measures
- Medication adherence - Pill Count [Time frame: During 3-month follow up phase]
- Medication adherence - Plasma Monitoring [Time frame: Blood concentration of antipsychotic medication will be measured on day of the first TDCS session before TDCS starts, after 1 week of TDCS is completed, after 2 weeks of TDCS are completed, and during the 3-month follow up phase.]
- Medication adherence - Clinician Rating [Time frame: During 3-month follow up phase]
Secondary outcome measures (1)
- Insight into Psychosis [Time frame: Illness awareness will be assessed before the TDCS phase begins, after 2 weeks of TDCS are completed, and during the 3-month follow up period]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Centre for Addiction and Mental Health — Toronto
Identifiers
NCT: NCT04033679 · 103-2018