General Practice Research Database Seroquel XR Safety Study

NCT01447082 | Completed

• 1 other identifier: D1444C00006
• Study Type: observational
• Target: 37,372
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Major Depressive Disorder; Bipolar Disorder

Keywords

atypical; antipsychotics; quetiapine

Outcome Measures

Primary Outcomes (10)

• 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

  During follow-up of a treatment episode estimated to be on average of 1.5 years

• Duration of treatment

  During follow-up estimated to be on average of 1.5 years.

• Duration of treatment episode

  Episode, defined as the treatment time from first to last prescription of quetiapine XR or other study drugs.

  During follow-up estimated to be on average of 1.5 years

• Comorbidities defined by clinical diagnosis or prescription

  Baseline and during follow up of treatment estimated to be on average 1.5 years

• Age

  Baseline

• Gender

  Baseline

• Dose

  During follow-up of treatment estimated to be on average 1.5 years

• Adherence

  During follow-up of treatment estimated to be on average 1.5 years

• The number of subjects to whom the drug was prescribed by the general practitioners.

  The number of patients, whom the drug was prescribed by the specified type of prescriber (specialist, general practitioner or another type of physician).

  During follow-up of treatment estimated to be on average 1.5 years

• Indication for treatment

  During follow-up of treatment estimated to be on averaged 1.5 years

Study Arms (2)

Quetiapine XR group

Non-quetiapine comparison group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

University Hospital Basel

Basel, Switzerland

Location

MeSH Terms

Conditions

Schizophrenia; Depressive Disorder, Major; Bipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Bipolar and Related Disorders

Study Officials

• Christoph R Meier, PROF DR PHIL

  University hospital of Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: October 5, 2011
• Study Start: October 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

CH (1)