Schizophrenia;Schizoaffective Clinical Trial
Official title:
The Effects of Adjunctive Transcranial Direct Current Stimulation on Treatment Adherence in Schizophrenia
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.
| Status | Recruiting |
| Enrollment | 106 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Centre for Addiction and Mental Health |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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. | |
| Primary | 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 | 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 |