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NCT Number: NCT04033679

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active TDCS

Other

Participants will receive active TDCS stimulation.

Sham tDCS

Other

Participants will receive sham TDCS stimulation.

Primary outcomes

  1. Medication adherence - Pill Count

    Time frame: 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.

  2. 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.

    Blood concentrations of antipsychotic medication will be measured at different points in the study to assess medication adherence.

  3. Medication adherence - Clinician Rating

    Time frame: 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.

Secondary outcomes

  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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ariel Graff, MD, PhD

CONTACT

[email protected]

416-535-8501 ext. 34834

Philip Gerretsen, MD, PhD

CONTACT

[email protected]

416-535-8501 ext. 39426

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 26, 2019
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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