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

NCT ID: NCT04033679

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-15

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia;Schizoaffective

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participant randomly assigned to receive either TDCS stimulation or sham stimulation.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double blind

Study Groups

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Active TDCS

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.

Group Type EXPERIMENTAL

Active TDCS

Intervention Type OTHER

Participants will receive active TDCS stimulation.

Sham TDCS

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.

Group Type SHAM_COMPARATOR

Sham TDCS

Intervention Type OTHER

Participants will receive sham TDCS stimulation.

Interventions

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Active TDCS

Participants will receive active TDCS stimulation.

Intervention Type OTHER

Sham TDCS

Participants will receive sham TDCS stimulation.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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Philip Gerretsen

Clinicial Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip Gerretsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

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Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Philip Gerretsen, MD, PhD

Role: CONTACT

416-535-8501 ext. 39426

Ariel Graff, MD, PhD

Role: CONTACT

416-535-8501 ext. 34834

Facility Contacts

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Philip Gerretsen, MD, PHD

Role: primary

416-535-8501 ext. 39426

Ariel Graff, MD, PHD

Role: backup

416-535-8501 ext. 34834

Related Links

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https://www.camh.ca/en/science-and-research

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.

Other Identifiers

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103-2018

Identifier Type: -

Identifier Source: org_study_id

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