Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8, Canada
Location status: Recruiting
Location contact
Ariel Graff, MD, PHD
CONTACT
416-535-8501 ext. 34834
Philip Gerretsen, MD, PHD
CONTACT
416-535-8501 ext. 39426
NCT Number: NCT04033679
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5T 1R8, Canada
Location status: Recruiting
Ariel Graff, MD, PHD
CONTACT
416-535-8501 ext. 34834
Philip Gerretsen, MD, PHD
CONTACT
416-535-8501 ext. 39426
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive active TDCS stimulation.
Participants will receive sham TDCS stimulation.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Ariel Graff, MD, PhD
CONTACT
416-535-8501 ext. 34834
Philip Gerretsen, MD, PhD
CONTACT
416-535-8501 ext. 39426
Centre for Addiction and Mental Health
Other
The Effects of Adjunctive Transcranial Direct Current Stimulation on Treatment Adherence in Schizophrenia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06192602
Behavior, Early Psychosis
Hong Kong, New Territories
View Trial DetailsNCT07165821
Behavior, Health Behavior
Nai Muang, Changwat Ubon Ratchathani, Thailand
View Trial DetailsNCT04191876
Behavior, Behavioral Symptoms
Glen Oaks, New York, United States
View Trial DetailsNCT03769493
Behavior, Health Behavior
Providence, Rhode Island, United States
View Trial Details