RecruitingNot Applicable

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

Canada106 participantsStarted 2019-08-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)
✕

What they're measuring

Medication adherence - Pill Count

Timeframe: During 3-month follow up phase

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.

Medication adherence - Clinician Rating

Timeframe: During 3-month follow up phase

Trial details

NCT IDNCT04033679

SponsorCentre for Addiction and Mental Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-31

Contact for this trial

Philip Gerretsen, MD, PhD

416-535-8501 philip.gerretsen@camh.ca

View on ClinicalTrials.gov More Schizophrenia;Schizoaffective trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)
✕

What they're measuring

Medication adherence - Pill Count

Timeframe: During 3-month follow up phase

Medication adherence - Plasma Monitoring

Medication adherence - Clinician Rating

Timeframe: During 3-month follow up phase