General Practice Research Database Seroquel XR Safety Study

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Schizophrenia, Major Depressive Disorder, Bipolar Disorder

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Quetiapine XR group<br> | |
| Non-quetiapine comparison group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atypical, antipsychotics, quetiapine