| Trial ID: | L4410 |
| Source ID: | NCT02582736
|
| Associated Drug: |
Olanzapine
|
| Title: |
Antipsychotics and Risk of Hyperglycemic Emergencies
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Psychotic Disorders|Schizophrenia|Schizoaffective Disorder|Bipolar Disorder|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Olanzapine|DRUG: Risperidone|DRUG: atypical antipsychotics (other)|DRUG: typical antipsychotics
|
| Outcome Measures: |
Primary: Hospitalization for a hyperglycemic emergency, A first hospital admission associated with an admission diagnosis of hyperglycemia (ICD-9: 790.20; ICD-10: R739), diabetic ketoacidosis (DKA) (ICD-9: 250.10,250.11,250.12,250.13; ICD-10: E10.1, E11.1, E13.1, E14.1), or hyperglycemic hyperosmolar state (HHS) (ICD-9: 250.20, 250.21,250.22,250.23; ICD-10: E11.0,E13.0, E14.0) in the 365 days following antipsychotic medication initiation (cohort entry)., 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. |
|
| Sponsor/Collaborators: |
Sponsor: Canadian Network for Observational Drug Effect Studies, CNODES | Collaborators: Drug Safety and Effectiveness Network, Canada|Canadian Institutes of Health Research (CIHR)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
725489
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2012-04
|
| Completion Date: |
2012-12
|
| Results First Posted: |
|
| Last Update Posted: |
2015-10-21
|
| Locations: |
Women's College Hospital, Women's College Research Institute, Toronto, Ontario, M5G 1N8, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT02582736
|
