PHARMO Institute Seroquel Safety Study | NCT01342120

Studies
PHARMO Institute Seroquel Safety Study

NCT01342120

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Sep 2, 2011Estimated

Enrollment

18,325Actual

Phase

Not provided

Conditions

Schizophrenia
Major Depressive Disorder
Bipolar Disorder
Generalized Anxiety Disorder

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Apr 21, 2011

First Submission Date that Met QC Criteria

Apr 25, 2011

First Posted Date

Apr 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2011

Last Update Posted Date

Sep 2, 2011Estimated

Name	Class
PHARMO Institute for Drug Outcomes Research	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

18,325Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Quetiapine		Quetipine users
All other atypical antipsychotics		All other atypical antipsychotics users
Risperidone		Risperidone users
Olanzapine		Olanzapine users

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Population based sample of about 2.5 millions residents in the Netherlands

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edith Heintjes	PHARMO Institute for Drug Outcomes Research	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27297785	Derived	Heintjes EM, Overbeek JA, Penning-van Beest FJ, Brobert G, Herings RM. Post authorization safety study comparing quetiapine to risperidone and olanzapine. Hum Psychopharmacol. 2016 Jul;31(4):304-12. doi: 10.1002/hup.2539. Epub 2016 Jun 13.

ID	Term
D012559	Schizophrenia
D003865	Depressive Disorder, Major
D001714	Bipolar Disorder
D000098647	Generalized Anxiety Disorder

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D003866	Depressive Disorder
D019964	Mood Disorders