Working… Menu
Trial record 64 of 69 for:    "Bipolar Disorder" | "Olanzapine"

PHARMO Institute Seroquel Safety Study (PHARMO II)

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. Identifier: NCT01342120
Recruitment Status : Completed
First Posted : April 27, 2011
Last Update Posted : September 2, 2011
PHARMO Institute for Drug Outcomes Research
Information provided by (Responsible Party):

Brief 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.

Condition or disease
Schizophrenia Major Depressive Disorder Bipolar Disorder Generalized Anxiety Disorder

Layout table for study information
Study Type : Observational
Actual Enrollment : 18325 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Seroquel Safety Study
Study Start Date : September 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Quetipine users
All other atypical antipsychotics
All other atypical antipsychotics users
Risperidone users
Olanzapine users

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 identifier (NCT number): NCT01342120

Sponsors and Collaborators
PHARMO Institute for Drug Outcomes Research
Layout table for investigator information
Principal Investigator: Edith Heintjes PHARMO Institute for Drug Outcomes Research

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca Identifier: NCT01342120     History of Changes
Other Study ID Numbers: D1443L00085
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: September 2, 2011
Last Verified: August 2011
Keywords provided by AstraZeneca:
atypical antipsychotics
Additional relevant MeSH terms:
Layout table for MeSH terms
Bipolar Disorder
Depressive Disorder
Depressive Disorder, Major
Anxiety Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Mood Disorders
Bipolar and Related Disorders
Antipsychotic Agents
Quetiapine Fumarate
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antidepressive Agents