General Practice Research Database Seroquel XR Safety Study

NCT ID: NCT01447082

Last Updated: 2014-02-07

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

37372 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-12-31

Brief Summary

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The main objective of this observational study is to characterize new users of quetiapine XR as well as new users of other study drugs (i.e. the comparison group) and to quantify the risk of developing newly diagnosed outcomes of interest in new users of quetiapine XR as well as in other study drugs.

Detailed Description

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Epidemiology study to assess the safety of a new slow-release form of Seroquel (quetiapine) in the post-marketing phase in the UK.

Conditions

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Schizophrenia Major Depressive Disorder Bipolar Disorder

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Quetiapine XR group

No interventions assigned to this group

Non-quetiapine comparison group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Episodes of new use (\>/=1 prescription) of quetiapine XR or other study drugs

Exclusion Criteria

* Less than two years of recorded history before the start of the marketing of quetiapine XR (or cohort entry date)
* If the duration and dose of the antipsychotic drug cannot be determined
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph R Meier, PROF DR PHIL

Role: PRINCIPAL_INVESTIGATOR

University hospital of Basel, Switzerland

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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D1444C00006

Identifier Type: -

Identifier Source: org_study_id

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