Antipsychotics and Risk of Hyperglycemic Emergencies

NCT02582736 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 725489

Last updated 2015-10-21

No results posted yet for this study

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

Interventions

DRUG

Olanzapine

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02582736 on ClinicalTrials.gov