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CompletedNCT01447082GPRD SeroquelSUpdated Feb 7, 2014

General Practice Research Database Seroquel XR Safety Study

An observational study in Schizophrenia, Major Depressive Disorder and Bipolar Disorder, sponsored by AstraZeneca. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-02-07.

Sponsored by AstraZeneca · Observational

Study type
Observational
Time perspective
Retrospective
Enrollment
37,372
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Schizophrenia
  • Major Depressive Disorder
  • Bipolar Disorder

Keywords

  • atypical
  • antipsychotics
  • quetiapine
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 37,372 is above the median of 178 across 491 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Time perspective
Retrospective
Enrollment
37,372 participants (actual)

Groups and cohorts

  • Quetiapine XR group
  • Non-quetiapine comparison group
06

What researchers measure

Primary outcomes

  1. 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

  2. Duration of treatment

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

  3. Duration of treatment episode

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

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

  4. Comorbidities defined by clinical diagnosis or prescription

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

  5. Age

    Time frame: Baseline

  6. Gender

    Time frame: Baseline

  7. Dose

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

  8. Adherence

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

  9. 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).

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

  10. Indication for treatment

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

07

Study locations

1 site
  • University Hospital Basel
    Basel, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01447082
Lead sponsor
AstraZeneca
Collaborators
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Oct 5, 2011
Start date
Oct 2008
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Feb 7, 2014

Study contacts

Christoph R Meier, PROF DR PHIL
principal investigator · University hospital of Basel, Switzerland
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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