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Completed

NCT Number: NCT01447082

General Practice Research Database Seroquel XR Safety Study

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

  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.

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

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

  10. Indication for treatment

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • University Hospital, Basel, Switzerland

Registry information

Official study title

Epidemiology Study to Assess the Safety of a New Slow-release Form of Seroquel (Quetiapine) in the Post-marketing Phase in the UK

Acronym: GPRD SeroquelS

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Oct 5, 2011
Registry last updated
Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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