Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active TDCS | Other | Participants will receive active TDCS stimulation. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
Not provided
Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip Gerretsen, MD, PhD | Contact | 416-535-8501 | 39426 | philip.gerretsen@camh.ca |
| Ariel Graff, MD, PhD | Contact | 416-535-8501 | 34834 | ariel.graff@camh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Philip Gerretsen, MD, PhD | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Addiction and Mental Health | Recruiting | Toronto | Ontario | M5T 1R8 | Canada |
Not provided
| Label | URL |
|---|---|
| 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. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
Not provided
Not provided
Participant randomly assigned to receive either TDCS stimulation or sham stimulation.
Not provided
Not provided
Double blind
| Sham TDCS |
| Other |
Participants will receive sham TDCS stimulation. |
|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |