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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01342120
Other study ID # D1443L00085
Secondary ID
Status Completed
Phase N/A
First received April 21, 2011
Last updated August 31, 2011
Start date September 2010
Est. completion date November 2010

Study information

Verified date August 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medicines Evaluation Board (MEB)
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 18325
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
AstraZeneca PHARMO Institute for Drug Outcomes Research

Outcome

Type Measure Description Time frame Safety issue
Primary The outcomes of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine vs corresponding incidence rates in users of comparison drugs Yes
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