General Practice Research Database Seroquel XR Safety Study (GPRD SeroquelS)

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01447082
First received: September 19, 2011
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

The main objective of this observational study is to characterize new users of quetiapine XR as well as new users of other study drugs (i.e. the comparison group) and to quantify the risk of developing newly diagnosed outcomes of interest in new users of quetiapine XR as well as in other study drugs.


Condition
Schizophrenia
Major Depressive Disorder
Bipolar Disorder

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Epidemiology Study to Assess the Safety of a New Slow-release Form of Seroquel (Quetiapine) in the Post-marketing Phase in the UK

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The outcome of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine XR vs corresponding incidence rates in users of comparison drugs [ Time Frame: During follow-up of a treatment episode estimated to be on average of 1.5 years ] [ Designated as safety issue: Yes ]
  • Duration of treatment [ Time Frame: During follow-up estimated to be on average of 1.5 years. ] [ Designated as safety issue: No ]
  • Duration of treatment episode [ Time Frame: During follow-up estimated to be on average of 1.5 years ] [ Designated as safety issue: No ]
    Episode, defined as the treatment time from first to last prescription of quetiapine XR or other study drugs.

  • Comorbidities defined by clinical diagnosis or prescription [ Time Frame: Baseline and during follow up of treatment estimated to be on average 1.5 years ] [ Designated as safety issue: No ]
  • Age [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Gender [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Dose [ Time Frame: During follow-up of treatment estimated to be on average 1.5 years ] [ Designated as safety issue: No ]
  • Adherence [ Time Frame: During follow-up of treatment estimated to be on average 1.5 years ] [ Designated as safety issue: No ]
  • The number of subjects to whom the drug was prescribed by the general practitioners. [ Time Frame: During follow-up of treatment estimated to be on average 1.5 years ] [ Designated as safety issue: No ]
    The number of patients, whom the drug was prescribed by the specified type of prescriber (specialist, general practitioner or another type of physician).

  • Indication for treatment [ Time Frame: During follow-up of treatment estimated to be on averaged 1.5 years ] [ Designated as safety issue: No ]

Enrollment: 37372
Study Start Date: October 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Quetiapine XR group
Non-quetiapine comparison group

Detailed Description:

Epidemiology study to assess the safety of a new slow-release form of Seroquel (quetiapine) in the post-marketing phase in the UK.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A sample of the general population in the UK consisting of 3 millions inhabitants.

Criteria

Inclusion Criteria:

  • Episodes of new use (>/=1 prescription) of quetiapine XR or other study drugs

Exclusion Criteria:

  • Less than two years of recorded history before the start of the marketing of quetiapine XR (or cohort entry date)
  • If the duration and dose of the antipsychotic drug cannot be determined
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447082

Locations
Switzerland
University Hospital Basel
Basel, Switzerland
Sponsors and Collaborators
AstraZeneca
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Christoph R Meier, PROF DR PHIL University hospital of Basel, Switzerland
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01447082     History of Changes
Other Study ID Numbers: D1444C00006
Study First Received: September 19, 2011
Last Updated: February 6, 2014
Health Authority: Netherlands: Medicines Evaluation Board (MEB)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
atypical
antipsychotics
quetiapine

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Depression
Schizophrenia
Depressive Disorder, Major
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
Quetiapine
Antipsychotic Agents
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 April 15, 2014