Risk of Breakthrough Symptoms On Antipsychotic Maintenance Medication When Remitted Patients Are Treated With Long-Acting Injectable Medications

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
View:

• 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

Locations
Other Locations
Canada
Centre for Addiction and Mental Health
RECRUITING
Toronto
Contact Information
Primary
Robert B Zipursky, MD
robert.zipursky@camh.ca
416-535-8501
Backup
Ofer Agid, MD
ofer.agid@camh.ca
416-535-8501
Time Frame
Start Date: 2023-01-09
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 180
Treatments
SGA-LAI
Outpatients with schizophrenia treated with second generation long-acting injectable antipsychotics whose psychotic symptoms have remitted.
Related Therapeutic Areas
Sponsors
Leads: Centre for Addiction and Mental Health
Collaborators: Janssen Inc.

This content was sourced from clinicaltrials.gov

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