Assessing the risk of relapse in schizophrenia patients on long-acting injectable medications
Risk of Breakthrough Symptoms On Antipsychotic Maintenance Medication When Remitted Patients Are Treated With Long-Acting Injectable Medications
Centre for Addiction and Mental Health · NCT05473741
This study is trying to see how likely people with schizophrenia are to have a relapse of symptoms while using long-acting injectable medications that they are sticking to for 48 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05473741 on ClinicalTrials.gov |
What this trial studies
This observational study will follow patients with schizophrenia who are treated with second generation long-acting injectable antipsychotic medications for 48 weeks. The aim is to determine the risk of psychotic symptom relapse in patients who have achieved remission and are adherent to their treatment. Participants will be assessed every 12 weeks to monitor their remission status and potential relapse, while also evaluating the association between antipsychotic plasma levels and relapse risk. The study is designed to control for factors that may contribute to breakthrough symptoms, such as poor adherence and concurrent mood disorders.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of schizophrenia who have been stable on a second generation long-acting injectable antipsychotic for at least three months.
Not a fit: Patients currently experiencing a major depressive or manic episode, or those with a history of untreated or unstable medical illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the risk factors for relapse in schizophrenia patients, leading to improved treatment strategies.
How similar studies have performed: While this approach is not entirely novel, it builds on existing knowledge regarding long-acting injectable antipsychotics and their role in managing schizophrenia, with previous studies indicating varying success in similar methodologies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- Centre for Addiction and Mental Health — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Robert B Zipursky, MD — Centre for Addiction and Mental Health
- Study coordinator: Robert B Zipursky, MD
- Email: robert.zipursky@camh.ca
- Phone: 416-535-8501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Schizophrenia, Schizophrenia Relapse, Relapse, Long-acting injectable antipsychotics, Remission