NCT02582736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
725,489

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
Last Updated

October 21, 2015

Status Verified

October 1, 2015

Enrollment Period

8 months

First QC Date

October 20, 2015

Last Update Submit

October 20, 2015

Conditions

Psychotic DisordersSchizophreniaSchizoaffective DisorderBipolar DisorderDiabetes Mellitus, Type 2

Keywords

AntipsychoticsDrug side effectsPsychosisHyperglycemic emergenciesDiabetesEpidemiologyDatabase researchCNODES

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (4)

Olanzapine

Exposure to olanzapine will be defined as a prescription for olanzapine on the date of cohort entry.

Drug: Olanzapine

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)

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

Risperidone (reference)

Exposure to risperidone will be defined as a prescription for risperidone on the date of cohort entry.

Drug: Risperidone

Interventions

OlanzapineDRUG

Exposure to olanzapine (ATC N05AH03) will be defined as a prescription for olanzapine on the date of cohort entry.

Also known as: atypical antipsychotic
Olanzapine
RisperidoneDRUG

Exposure to risperidone (ATC N05AX08) will be defined will be defined as a prescription for risperidone on the date of cohort entry.

Also known as: atypical antipsychotic
Risperidone (reference)
atypical antipsychotics (other)DRUG

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.

Also known as: Clozapine, Quetiapine, Ziprasidone, Paliperidone, Aripiprazole
Other atypical antipsychotics
typical antipsychoticsDRUG

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.

Also known as: Chlormezanone, Chlorpromazine, Chlorprothixene, Flupenthixol, Fluphenazine, Fluspirilene, Haloperidol, Levomepromazine, Loxapine, Mesoridazine, Methotrimeprazine, Perphenazine, Pimozide, Pipotiazine, Tetrabenazine, Thiopropazate, Thioproperazine, Thioridazine, Thiothixene, Trifluoperazine, Zuclopenthixol
Typical antipsychotics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's College Hospital, Women's College Research Institute

Toronto, Ontario, M5G 1N8, Canada

Location

Related Publications (1)

  • Lipscombe LL, Austin PC, Alessi-Severini S, Blackburn DF, Blais L, Bresee L, Filion KB, Kawasumi Y, Kurdyak P, Platt RW, Tamim H, Paterson JM; Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. Atypical antipsychotics and hyperglycemic emergencies: multicentre, retrospective cohort study of administrative data. Schizophr Res. 2014 Apr;154(1-3):54-60. doi: 10.1016/j.schres.2014.01.043. Epub 2014 Feb 24.

    PMID: 24581419RESULT

Related Links

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaBipolar DisorderDiabetes Mellitus, Type 2Drug-Related Side Effects and Adverse ReactionsDiabetes Mellitus

Interventions

OlanzapineRisperidoneClozapineQuetiapine FumarateziprasidonePaliperidone PalmitateAripiprazoleChlormezanoneChlorpromazineChlorprothixeneFlupenthixolFluphenazineFluspirileneHaloperidolMethotrimeprazineLoxapineMesoridazinePerphenazinePimozidepipothiazineTetrabenazinethiopropazatethioproperazineThioridazineThiothixeneTrifluoperazineClopenthixol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingDibenzazepinesHeterocyclic Compounds, 3-RingDibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsIsoxazolesAzolesPiperazinesQuinolonesQuinolinesThiazinesPhenothiazinesThioxanthenesXanthenesSpiro CompoundsHydrocarbons, CyclicHydrocarbonsImidazolesPiperidinesPolycyclic CompoundsButyrophenonesKetonesDibenzoxazepinesBenzimidazolesQuinolizines

Study Officials

  • Lorraine Lipscombe, MD, MSc

    Women's College Hospital, Women's College Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2015

First Posted

October 21, 2015

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 21, 2015

Record last verified: 2015-10

Locations

CA(1)