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PHARMO Institute Seroquel Safety Study (PHARMO II)

This study has been completed.
Sponsor:
Collaborator:
PHARMO Institute for Drug Outcomes Research
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01342120
First received: April 21, 2011
Last updated: August 31, 2011
Last verified: August 2011
History of Changes
  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:

U.S. FDA Resources

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 [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342120

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01342120     History of Changes
Other Study ID Numbers: D1443L00085
Study First Received: April 21, 2011
Last Updated: August 31, 2011
Health Authority: Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by AstraZeneca:
atypical antipsychotics
quetiapine

Additional relevant MeSH terms:
Anxiety Disorders
Bipolar Disorder
Depressive Disorder
Depression
Schizophrenia
Depressive Disorder, Major
Mental Disorders
Affective Disorders, Psychotic
Mood Disorders
Behavioral Symptoms
 Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Quetiapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013