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

Primary Purpose

Schizophrenia;Schizoaffective

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Active TDCS
Sham TDCS
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia;Schizoaffective focused on measuring Magnetic resonance imaging, Brain stimulation, Medication adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre for Addiction and Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active TDCS

Sham TDCS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Insight into Psychosis
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.

Full Information

First Posted
May 23, 2019
Last Updated
September 14, 2023
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT04033679
Brief Title
The Effects of Non-invasive Brain Stimulation on Treatment Adherence in Schizophrenia
Official Title
The Effects of Adjunctive Transcranial Direct Current Stimulation on Treatment Adherence in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia;Schizoaffective
Keywords
Magnetic resonance imaging, Brain stimulation, Medication adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participant randomly assigned to receive either TDCS stimulation or sham stimulation.
Masking
ParticipantOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active TDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham TDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Active TDCS
Intervention Description
Participants will receive active TDCS stimulation.
Intervention Type
Other
Intervention Name(s)
Sham TDCS
Intervention Description
Participants will receive sham TDCS stimulation.
Primary Outcome Measure Information:
Title
Medication adherence - Pill Count
Description
Pill count or percentage of weekly antipsychotic medication adherence will be assessed during the 3-month follow up phase after TDCS is completed.
Time Frame
During 3-month follow up phase
Title
Medication adherence - Plasma Monitoring
Description
Blood concentrations of antipsychotic medication will be measured at different points in the study to assess medication adherence.
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.
Title
Medication adherence - Clinician Rating
Description
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.
Time Frame
During 3-month follow up phase
Secondary Outcome Measure Information:
Title
Insight into Psychosis
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Gerretsen, MD, PhD
Phone
416-535-8501
Ext
39426
Email
philip.gerretsen@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ariel Graff, MD, PhD
Phone
416-535-8501
Ext
34834
Email
ariel.graff@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Gerretsen, MD, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Gerretsen, MD, PHD
Phone
416-535-8501
Ext
39426
Email
philip.gerretsen@camh.ca
First Name & Middle Initial & Last Name & Degree
Ariel Graff, MD, PHD
Phone
416-535-8501
Ext
34834
Email
ariel.graff@camh.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.camh.ca/en/science-and-research
Description
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.

Learn more about this trial

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

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