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NCT00758251 Clinical Trial

Observation of Change in Clinical Global Impression Scores in Schizophrenia Patients Receiving Seroquel XR Treatment

Schizophrenia Clinical Trial

Official title:
Observation of Change in Clinical Global Impression Scores in Schizophrenia Patients Receiving Seroquel XR Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00758251
Other study ID # NIS-NLV-SER-2008/1
Secondary ID
Status Completed
Phase N/A
First received September 23, 2008
Last updated December 8, 2010
Start date September 2008
Est. completion date March 2009

Study information
Verified date December 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Latvia: State Agency of Medicines
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess severity of illness in schizophrenia patients in routine clinical practice at the time of entry in the study and after the treatment with Seroquel XR for 8 weeks.

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 80
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients with Schizophrenia prescribed on Seroquel XR according to the approved product information before inclusion in this non-interventional study

- Signed and dated Patient Informed Consent (ICF)

Exclusion Criteria:

- Hypersensitivity to the active substance or to any of the excipients of Seroquel XR

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Latvia Research Site Bauska
Latvia Research SIte Cesis
Latvia Research Site Daugavpils
Latvia Research Site Dobele
Latvia Research Site Jekabpils
Latvia Research Site Jelgava
Latvia Research Site Jurmala
Latvia Research Site Kuldiga
Latvia Research Site Liepaja
Latvia Research Site Riga
Latvia Research Site Saldus
Latvia Research Site Strenci
Latvia Research Site Talsi
Latvia Research Site Tukums
Latvia Research Site Valmiera

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Latvia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in CGI scores and BPRS comparing visits 1 and 3. twice with 4 week interval No
Secondary To evaluate compliance to therapy twice with 4 week interval No
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