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Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect

NCT ID: NCT00534222

Last Updated: 2011-12-14

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

387 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-12-31

Brief Summary

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With this observational study we want to examine if the intensity of agitation, the intensity of psychotic symptoms and the presence of sleeping disorder predict the success of the treatment with a atypical antipsychotic after 12 weeks of treatment with patients with a psychotic and/or manic episode. In this study it will be examined what the percentage of patients with a 2-point improvement at the CGI-scale is. Of these group, the responders, retrospective the profile of the responders will be analysed (key-factors and confounders).

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Detailed Description

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Conditions

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Mania Schizophrenia

Keywords

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Patients with a manic episode Patients diagnosed w/schizophrenia, who start a treatment with an atypical antipsychotic & who are at least scored as moderately ill on the CGI at baseline

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Quetiapine

No interventions assigned to this group

Olanzapine

No interventions assigned to this group

Risperidone

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with a manic episode or patients diagnosed with schizophrenia (psychotic episode)
* Patients who start a treatment with an atypical antipsychotic : quetiapine, olanzapine or risperidone
* Patients who are prepared to consent to make the coded data available to AstraZeneca
* Patients with a CGI ≥ 4

Exclusion Criteria

* Patients with a serious underlying disease (including renal or hepatic insufficiency, cancer, cardiovascular diseases and suchlike).
* Contra-indications for quetiapine, olanzapine or risperidone according to the SmPC for these products
* Patients unable to give informed consent according to the attending physician
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Alkmaar, , Netherlands

Site Status

Research Site

Almelo, , Netherlands

Site Status

Research Site

Alphen Aan de Rigjn, , Netherlands

Site Status

Research Site

Amersfoort, , Netherlands

Site Status

Research Site

Amstelveen, , Netherlands

Site Status

Research Site

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL 401241

Identifier Type: REGISTRY

Identifier Source: secondary_id

NIS-NNL-SER-2005/1

Identifier Type: -

Identifier Source: org_study_id