CompletedNot Applicable

Antipsychotics and Risk of Hyperglycemic Emergencies

Canada725,489 participantsStarted 2012-04

Plain-language summary

The purpose of this study is to determine whether the use of atypical antipsychotic medication increases the risk of hospitalization for a hyperglycemic emergency. The investigators will carry out separate population-based cohort studies using administrative health databases in eight jurisdictions in Canada and the UK. Cohort entry will be defined by the initiation of a new antipsychotic medication. Follow-up will continue until hospitalization for a hyperglycemic emergency or the end of 365 days. The results from the separate sites will be combined to provide an overall assessment of the risk of hyperglycemic emergencies among new users of various antipsychotic drugs.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with a with a first-time prescription for an antipsychotic medication * Patients at least 18 years of age at cohort entry (except Alberta, Ontario, and Nova Scotia, where patients will be a least 66 years of age) * Patients with at least 1 year of history in the database Exclusion Criteria: * Patients aged \<18 years on the date of cohort entry (or \< 66 years in Alberta, Ontario and Nova Scotia) * Received a prescription for an antipsychotic medication in the 365 days prior to cohort entry * Patients who were hospitalized with the primary study outcome \<30 days prior to cohort entry * Had \<1 year of provincial Medicare or GPRD enrollment preceding cohort entry * Hospitalized for \>30 consecutive days in the 365 days prior to cohort entry * Received renal dialysis or palliative care in the 365 days prior to cohort entry * Patients in a long term care facility * Patients who received \>1 antipsychotic medication on the date of cohort entry

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hospitalization for a hyperglycemic emergency

Timeframe: Patients will be followed from the date of study cohort entry until the occurrence of a hyperglycemic emergency, censoring, or for up to 365 days.

Trial details

NCT IDNCT02582736

SponsorCanadian Network for Observational Drug Effect Studies, CNODES

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-12

View on ClinicalTrials.gov More Psychotic Disorders trials