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Trial record 8 of 12 for:    pimozide

Antipsychotics and Risk of Hyperglycemic Emergencies

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ClinicalTrials.gov Identifier: NCT02582736
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : October 21, 2015
Sponsor:
Collaborators:
Drug Safety and Effectiveness Network, Canada
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Canadian Network for Observational Drug Effect Studies, CNODES

Brief 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.


Condition or disease Intervention/treatment
Psychotic Disorders Schizophrenia Schizoaffective Disorder Bipolar Disorder Diabetes Mellitus, Type 2 Drug: Olanzapine Drug: Risperidone Drug: atypical antipsychotics (other) Drug: typical antipsychotics

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 725489 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Atypical Antipsychotics and Hyperglycemic Emergencies: Multicentre, Retrospective Cohort Study of Administrative Data
Study Start Date : April 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Olanzapine
Exposure to olanzapine will be defined as a prescription for olanzapine on the date of cohort entry.
Drug: Olanzapine
Exposure to olanzapine (ATC N05AH03) will be defined as a prescription for olanzapine on the date of cohort entry.
Other Name: atypical antipsychotic

Other atypical antipsychotics
Exposure to atypical antipsychotics will be defined as a prescription for an atypical antipsychotic other than olanzapine (clozapine, quetiapine, ziprasidone, paliperidone, or aripiprazole) 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.
Other Names:
  • Clozapine
  • Quetiapine
  • Ziprasidone
  • Paliperidone
  • Aripiprazole

Typical antipsychotics
Exposure to typical antipsychotics will be defined as a prescription for a typical antipsychotic (chlormezanone, chlorpromazine, chlorprothixene, flupenthixol, fluphenazine, fluspirilene, haloperidol, levomepromazine, loxapine, mesoridazine, methotrimeprazine, perphenazine, pimozide, pipotiazine, tetrabenazine, thiopropazate, thioproperazine, thioridazine, thiothixene, trifluoperazine or zuclopenthixol) 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.
Other Names:
  • Chlormezanone
  • Chlorpromazine
  • Chlorprothixene
  • Flupenthixol
  • Fluphenazine
  • Fluspirilene
  • Haloperidol
  • Levomepromazine
  • Loxapine
  • Mesoridazine
  • Methotrimeprazine
  • Perphenazine
  • Pimozide
  • Pipotiazine
  • Tetrabenazine
  • Thiopropazate
  • Thioproperazine
  • Thioridazine
  • Thiothixene
  • Trifluoperazine
  • Zuclopenthixol

Risperidone (reference)
Exposure to risperidone will be defined as a prescription for risperidone 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.
Other Name: atypical antipsychotic




Primary Outcome Measures :
  1. Hospitalization for a hyperglycemic emergency [ Time Frame: 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. ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In each jurisdiction, the investigators will assemble a study cohort that includes all patients with a first-time prescription for an antipsychotic medication between April 1, 1998 (or one year after the beginning of data availability) and March 31, 2010. The date of study cohort entry is defined by the prescription date of the newly-prescribed antipsychotic.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582736


Locations
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Canada, Ontario
Women's College Hospital, Women's College Research Institute
Toronto, Ontario, Canada, M5G 1N8
Sponsors and Collaborators
Canadian Network for Observational Drug Effect Studies, CNODES
Drug Safety and Effectiveness Network, Canada
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Lorraine Lipscombe, MD, MSc Women's College Hospital, Women's College Research Institute

Additional Information:
Publications of Results:
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Responsible Party: Canadian Network for Observational Drug Effect Studies, CNODES
ClinicalTrials.gov Identifier: NCT02582736     History of Changes
Other Study ID Numbers: Q10-12
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015
Keywords provided by Canadian Network for Observational Drug Effect Studies, CNODES:
Antipsychotics
Drug side effects
Psychosis
Hyperglycemic emergencies
Diabetes
Epidemiology
Database research
CNODES
Additional relevant MeSH terms:
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Pimozide
Diabetes Mellitus, Type 2
Disease
Emergencies
Schizophrenia
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Disease Attributes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bipolar and Related Disorders
Methotrimeprazine
Haloperidol
Olanzapine
Chlorpromazine
Trifluoperazine
Risperidone
Antipsychotic Agents
Aripiprazole
Quetiapine Fumarate
Paliperidone Palmitate
Ziprasidone
Clozapine
Loxapine
Perphenazine