Schizophrenia;Schizoaffective
Conditions
Keywords
Magnetic resonance imaging, Brain stimulation, Medication adherence
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 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
OTHERActive TDCS
Participants will receive active TDCS stimulation.
OTHERSham TDCS
Participants will receive sham TDCS stimulation.
Sponsors
Centre for Addiction and Mental Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double blind
Intervention model description
Participant randomly assigned to receive either TDCS stimulation or sham stimulation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female participants of any race or ethnicity 2. Inpatients or outpatients ≥18 years of age 3. DSM-V diagnosis of SCZ or schizoaffective disorder 4. Capable of consenting to participate in the research study 5. 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
1. Unwilling or incapable to consent to the study based on the MacArthur Test of Competence 2. Unstable medical or any concomitant major medical or neurological illness, including a history of seizures 3. Acute suicidal or homicidal ideation 4. Formal thought disorder rating ≥3 on the Positive and Negative Syndrome Scale (PANSS) P2 conceptual disorganization item 5. DSM-V substance dependence (except caffeine and nicotine) within 1 month of entering the study\* 6. Positive urine drug screen except for cannabis/marijuana at the screening visit 7. Metal implants or pacemaker precluding an MRI scan or other contraindications to MRI (eg., claustrophobia) 8. Pregnancy 9. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence - Plasma Monitoring | 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. | Blood concentrations of antipsychotic medication will be measured at different points in the study to assess medication adherence. |
| Medication adherence - Clinician Rating | During 3-month follow up phase | The Clinician Adherence Rating Scale is a 7-point clinician rated measure which takes into account patients' self-report, medication adherence, and changes in plasma concentrations to provide a comprehensive assessment of antipsychotic medication adherence. A higher score represents greater adherence. |
| Medication adherence - Pill Count | During 3-month follow up phase | Pill count or percentage of weekly antipsychotic medication adherence will be assessed during the 3-month follow up phase after TDCS is completed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insight into Psychosis | 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 | Level of illness awareness will be assessed by the VAGUS Insight into Psychosis scale. The VAGUS assesses the core domains of insight into psychosis. VAGUS has both self-report and clinician-rated versions with good inter-scale reliability and test-retest reliability. Higher scores indicate better insight into illness. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORPhilip Gerretsen, MD, PhD
Centre for Addiction and Mental Health
Outcome results
None listed