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Risk of Breakthrough Symptoms With Long-Acting Injectable Medications

Schizophrenia | Schizophrenia Relapse

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 to 65

Participation Criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* Current DSM-5 major depressive episode or manic episode
* Receiving any oral antipsychotic medication in the past 3 months
* 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
* Inability to read and communicate in English

Study Location

Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Robert B Zipursky, MD

[email protected]
4165358501
Backup Contact

Ofer Agid, MD

[email protected]
4165358501
Study Sponsored By
Centre for Addiction and Mental Health
Participants Required
More Information
Study ID: NCT05473741