NCT05473741Completed
Risk of Breakthrough Symptoms With Long-Acting Injectable Medications
Risk of Breakthrough Symptoms On Antipsychotic Maintenance Medication When Remitted Patients Are Treated With Long-Acting Injectable Medications
Source: ClinicalTrials.gov · Last updated 14 Apr 2026
Brief summary (registry, in English)
This prospective longitudinal cohort study will follow patients with schizophrenia who are treated with second generation long-acting injectable antipsychotic medications (LAIs) for 48 weeks to determine the risk of psychotic symptom relapse when treatment adherence is established. The study is designed to minimize the other factors that have contributed to breakthrough psychotic symptoms in patients treated with LAIs including poor adherence, substance use, concurrent mood disorders, poor treatment response, failed cross-titration, and insufficient dosing. Eligible subjects will undergo a screening visit to document that inclusion criteria are met and those meeting exclusion criteria are excluded. Participants will be assessed every 12 weeks to determine whether they remain in remission or meet criteria for a relapse. More comprehensive assessment will be completed at the beginning of the study (baseline visit), at the 24-week study midpoint and the 48-week study endpoint. Plasma antipsychotic levels will be measured at these three study time points to investigate associations between plasma levels and remission/relapse status as well as side effects. Plasma prolactin will also be measured to assess the association with sexual side effects. Hemoglobin A1c and measures of total cholesterol, triglycerides, HDL cholesterol and LDL cholesterol will be obtained to assess the effects of SGA LAIs on these measures.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 51 (actual)
- First submitted
- 22 Jul 2022
- Start date
- 11 Jan 2023
- Primary completion date
- 27 Oct 2025
- Lead sponsor
- Centre for Addiction and Mental Health
- Diseases
- Schizophrenia
- NCT number
- NCT05473741
What you commit to
- Study type: Observational
- Participants enrolled: 51
- From 11 Jan 2023 to the primary completion date, 27 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving any oral antipsychotic medication in the past 3 months
Other illness
- History of organic brain disease (e.g. cerebrovascular accident, Huntington's Disease, Parkinson's Disease, epilepsy, etc.)
- History of untreated or unstable medical illness (e.g. thyroid disease, cancer)
- History of electroconvulsive therapy (ECT) in the past year
- History of suicide attempt in the past 3 months
- History of psychiatric hospitalization in the past 3 months
Other
- Current DSM-5 major depressive episode or manic episode
- Inability to read and communicate in English
Who the study is looking for
- DSM-5 Schizophrenia
- Age 18-65 years
- On SGA LAI: paliperidone palmitate (4-week or 12-week formulations), risperidone or aripiprazole
- Receiving LAI injections through clinical services based at CAMH
- History of improvement in psychotic symptoms with antipsychotic medication as evidenced by a rating of mild or less on the Clinical Global Impression - Severity (CGI-S) for Positive symptoms
- Demonstrated adherence to LAIs defined as not having received any injections more that 7 days past its due date in the past 3 months
- On stable dose of LAI for 3 months or longer
- Capable of providing informed consent for participation in this study
Age in the registry: 18 years to 65 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Addiction and Mental Health Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.