Clinical trial NCT04033679: The Effects of Non-invasive Brain Stimulation on Treatment Adherence in Schizophrenia
Official title: The Effects of Adjunctive Transcranial Direct Current Stimulation on Treatment Adherence in Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia;Schizoaffective
Keywords: Magnetic resonance imaging
Brain stimulation
Medication adherence
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participant randomly assigned to receive either TDCS stimulation or sham stimulation.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Medication adherence - Pill Count
timeFrame: During 3-month follow up phase
measure: Medication adherence - Plasma Monitoring
timeFrame: 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.
measure: Medication adherence - Clinician Rating
timeFrame: During 3-month follow up phase
Secondary outcomes:
measure: Insight into Psychosis
timeFrame: 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
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Philip Gerretsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: