Non-invasive brain stimulation to improve medication adherence in schizophrenia

The Effects of Adjunctive Transcranial Direct Current Stimulation on Treatment Adherence in Schizophrenia

This study is testing whether a non-invasive brain stimulation technique can help people with schizophrenia stick to their medication better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 106 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre for Addiction and Mental Health (other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT04033679 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, as an adjunctive treatment aimed at improving adherence to antipsychotic medications in patients diagnosed with schizophrenia or schizoaffective disorder. Participants will be randomly assigned to receive either active or sham tDCS over 20 sessions, administered twice daily for 10 days. The study will assess medication adherence through pill counts, plasma drug levels, and clinician evaluations, alongside brain imaging before and after the intervention to observe any changes in brain activity related to insight and adherence.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a DSM-V diagnosis of schizophrenia or schizoaffective disorder who are stable on their antipsychotic medications.

Not a fit: Patients with unstable medical conditions, severe thought disorders, or those unable to consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance medication adherence in patients with schizophrenia, leading to better treatment outcomes.

How similar studies have performed: While the use of tDCS in psychiatric conditions is emerging, this specific application for improving medication adherence in schizophrenia is relatively novel and has not been extensively tested.

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.

Where this trial is running

Toronto, Ontario

• Centre for Addiction and Mental Health — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Philip Gerretsen, MD, PhD — Centre for Addiction and Mental Health
• Study coordinator: Philip Gerretsen, MD, PhD

Conditions: Schizophrenia, Schizoaffective, Magnetic resonance imaging, Brain stimulation, Medication adherence