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PHARMO Institute Seroquel Safety Study (PHARMO II)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01342120
First Posted: April 27, 2011
Last Update Posted: September 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
PHARMO Institute for Drug Outcomes Research
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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.

Condition
Schizophrenia Major Depressive Disorder Bipolar Disorder Generalized Anxiety Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Seroquel Safety Study

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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

Enrollment: 18325
Study Start Date: September 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Quetiapine
Quetipine users
All other atypical antipsychotics
All other atypical antipsychotics users
Risperidone
Risperidone users
Olanzapine
Olanzapine users

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population based sample of about 2.5 millions residents in the Netherlands
Criteria

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
  Contacts and Locations
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): NCT01342120


Sponsors and Collaborators
AstraZeneca
PHARMO Institute for Drug Outcomes Research
Investigators
Principal Investigator: Edith Heintjes PHARMO Institute for Drug Outcomes Research
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01342120     History of Changes
Other Study ID Numbers: D1443L00085
First Submitted: April 21, 2011
First Posted: April 27, 2011
Last Update Posted: September 2, 2011
Last Verified: August 2011

Keywords provided by AstraZeneca:
atypical antipsychotics
quetiapine

Additional relevant MeSH terms:
Disease
Schizophrenia
Depressive Disorder
Depression
Depressive Disorder, Major
Bipolar Disorder
Anxiety Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Mood Disorders
Behavioral Symptoms
Bipolar and Related Disorders
Antipsychotic Agents
Quetiapine Fumarate
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs