PHARMO Institute Seroquel Safety Study

NCT ID: NCT01342120

Last Updated: 2011-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18325 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this observational study is to study specific outcomes of interest in users of quetiapine compared with all other atypical antipsychotics and specifically olanzapine and risperidone. The outcomes of interest are all-cause mortality, failed suicide attempts, extrapyramidal symptoms, diabetes mellitus, hypothyroidism, acute myocardial infarction and stroke. This retrospective cohort study is based on population-based record linkage system (PHARMO RLS) capturing about 2.5 millions residents in the Netherlands.

Detailed Description

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Conditions

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Schizophrenia Major Depressive Disorder Bipolar Disorder Generalized Anxiety Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Quetiapine

Quetipine users

No interventions assigned to this group

All other atypical antipsychotics

All other atypical antipsychotics users

No interventions assigned to this group

Risperidone

Risperidone users

No interventions assigned to this group

Olanzapine

Olanzapine users

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Episode of new use of atypical antipsychotics in naïve (not used antipsychotic drugs for a year) users of antipsychotics.

Exclusion Criteria

* less than a year of recorded history before the cohort entry date
* use of multiple antipsychotics concomitantly
* duration and dose of the antipsychotic drug cannot be determined
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PHARMO Institute for Drug Outcomes Research

UNKNOWN

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edith Heintjes

Role: PRINCIPAL_INVESTIGATOR

PHARMO Institute for Drug Outcomes Research

References

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Heintjes EM, Overbeek JA, Penning-van Beest FJ, Brobert G, Herings RM. Post authorization safety study comparing quetiapine to risperidone and olanzapine. Hum Psychopharmacol. 2016 Jul;31(4):304-12. doi: 10.1002/hup.2539. Epub 2016 Jun 13.

Reference Type DERIVED
PMID: 27297785 (View on PubMed)

Other Identifiers

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D1443L00085

Identifier Type: -

Identifier Source: org_study_id

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