Antipsychotics and Risk of Hyperglycemic Emergencies
NCT02582736 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 725489
Last updated 2015-10-21
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.
Conditions
- Psychotic Disorders
- Schizophrenia
- Schizoaffective Disorder
- Bipolar Disorder
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
Exposure to olanzapine (ATC N05AH03) will be defined as a prescription for olanzapine on the date of cohort entry.
- DRUG
-
Risperidone
Exposure to risperidone (ATC N05AX08) will be defined will be defined as a prescription for risperidone on the date of cohort entry.
- DRUG
-
atypical antipsychotics (other)
Exposure to other atypitical antipsychotics (ATC N05AH02, N05AH04, N05AE04, N05AX13, N05AX12) will be defined will be defined as a prescription for an atypical antipsychotic other than olanzapine on the date of cohort entry.
- DRUG
-
typical antipsychotics
Exposure to typical antipsychotics (M03BB02, N05AA01, N05AF03, N05AF01, N05AB02, N05AG01, N05AD01, N05AA02, N05AH01, N05AC03, N05AB03, N05AG02, N05AC04, N07XX06, N05AB05, N05AB08, N05AC02, N05AF04, N05AB06, N05AF05) will be defined as a prescription for a typical antipsychotic on the date of cohort entry.
Sponsors & Collaborators
-
Drug Safety and Effectiveness Network, Canada
collaborator OTHER -
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
Canadian Network for Observational Drug Effect Studies, CNODES
lead OTHER
Principal Investigators
-
Lorraine Lipscombe, MD, MSc · Women's College Hospital, Women's College Research Institute
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-04-30
- Primary Completion
- 2012-12-31
- Completion
- 2012-12-31
Countries
- Canada
Study Locations
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