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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00534222
Other study ID # NIS-NNL-SER-2005/1
Secondary ID NL 401241
Status Completed
Phase N/A
First received September 20, 2007
Last updated December 13, 2011
Start date September 2005
Est. completion date December 2007

Study information

Verified date April 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Not required for this study:
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 387
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Research Site Alkmaar
Netherlands Research Site Almelo
Netherlands Research Site Alphen aan de Rigjn
Netherlands Research Site Amersfoort
Netherlands Research Site Amstelveen
Netherlands Research Site Amsterdam

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Netherlands, 

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