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

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ClinicalTrials.gov Identifier: NCT04033679
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Gerretsen, Centre for Addiction and Mental Health

Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE July 26, 2019
Last Update Posted Date July 26, 2019
Estimated Study Start Date  ICMJE August 15, 2019
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Non-invasive Brain Stimulation on Treatment Adherence in Schizophrenia
Official Title  ICMJE The Effects of Adjunctive Transcranial Direct Current Stimulation on Treatment Adherence in Schizophrenia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participant randomly assigned to receive either TDCS stimulation or sham stimulation.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Double blind
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia;Schizoaffective
Intervention  ICMJE
  • Other: Active TDCS
    Participants will receive active TDCS stimulation.
  • Other: Sham TDCS
    Participants will receive sham TDCS stimulation.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Other: Active TDCS
  • Sham Comparator: 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.
    Intervention: Other: Sham TDCS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2019)
106
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 aripiprazole or risperidone 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 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 at the screening visit will be excluded. Substance use and urine drug screens will be assessed at subsequent study visits.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Philip Gerretsen, MD, PhD 416-535-8501 ext 39426 philip.gerretsen@camh.ca
Contact: Ariel Graff, MD, PhD 416-535-8501 ext 34834 ariel.graff@camh.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04033679
Other Study ID Numbers  ICMJE 103-2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Philip Gerretsen, Centre for Addiction and Mental Health
Study Sponsor  ICMJE Centre for Addiction and Mental Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip Gerretsen, MD, PhD Centre for Addiction and Mental Health
PRS Account Centre for Addiction and Mental Health
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP