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

NCT04033679 | Recruiting

• 1 other identifier: 103-2018
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia;Schizoaffective

Keywords

Magnetic resonance imaging; Brain stimulation; Medication adherence

Outcome Measures

Primary Outcomes (3)

• Medication adherence - Pill Count

  Pill count or percentage of weekly antipsychotic medication adherence will be assessed during the 3-month follow up phase after TDCS is completed.

  During 3-month follow up phase

• Medication adherence - Plasma Monitoring

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

  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

  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.

  During 3-month follow up phase

Secondary Outcomes (1)

• 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

Study Arms (2)

Active TDCS

EXPERIMENTAL

In the active condition, a constant current of 2 mA intensity will be applied for 20 min to the parietal regions, using P3 as the cathode and P4 as the anode.

Other: Active TDCS

Sham TDCS

SHAM COMPARATOR

In the sham condition, stimulation will be administered using the same parameters at the site of active treatment, but the current will be turned off after 30 seconds.

Other: Sham TDCS

Interventions

Active TDCS OTHER

Participants will receive active TDCS stimulation.

Active TDCS

Sham TDCS OTHER

Participants will receive sham TDCS stimulation.

Sham TDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

RECRUITING

Related Links

• The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.

MeSH Terms

Conditions

Psychotic Disorders; Medication Adherence

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Philip Gerretsen, MD, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip Gerretsen, MD, PhD

CONTACT

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

Ariel Graff, MD, PhD

CONTACT

416-535-8501; ariel.graff@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinicial Scientist

Model Details: Participant randomly assigned to receive either TDCS stimulation or sham stimulation.

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: July 26, 2019
• Study Start: August 15, 2019
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)