NIS to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-11-30

Brief Summary

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The purpose of the study is to monitor the general functional changes among patients with schizophrenia, treated with atypical antipsychotics dosed once daily for a period of 6 months.The primary study objective is to compare general functioning of patients with schizophrenia treated with Seroquel SR between baseline and the last study visit. The secondary study objectives are to compare general functioning of patients with schizophrenia treated with other atypical antipsychotic medicinal products administered once daily between baseline and the last study visit, monitoring of other indicators of clinical improvement, evaluation of patient compliance and assessment of occurrence of adverse effects

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Seroquel SR: Patients whose symptoms are controlled with Seroquel SR and started with the therapy up to 1 month before the inclusion

No interventions assigned to this group

2

Atypical antipsychotics: Patients whose symptoms are controlled with atypical antipsychotic in once daily formulation (excluding Seroquel SR) and started with the therapy up to 1 month before the inclusion

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* patients have a diagnosis of schizophrenia, as defined by DSM-IV-TR
* patients' symptoms are controlled with Seroquel SR started up to 1 month before the inclusion
* or patients' symptoms are controlled with other atypical antipsychotic in once daily formulation started up to 1 month before the inclusion

Exclusion Criteria

* patients who are treated with Seroquel SR or other antipsychotic more than 1 month
* patients with prescribed antipsychotic combinations
* pregnant women or women who are breast-feeding
* patients who have been treated with antipsychotics in depot formulations for the last two months

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Pregelj, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Psihiatricna klinika Ljubljana, Studenec 48, 1260 Ljubljana

Review additional registry numbers or institutional identifiers associated with this trial.

NIS-NSI-SER-2008/1

Identifier Type: -

Identifier Source: org_study_id

NIS to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

1

2

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

AstraZeneca

Responsible Party

Principal Investigators

Peter Pregelj, MD, PhD

Locations

Research Site

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Countries

Other Identifiers

NIS-NSI-SER-2008/1