Evaluating Subjective Well-being in Schizophrenic Patients Treated With quetiapineXR® and Other Atypical Antipsychotics

Schizophrenia Clinical Trial

— Xperience  

Official title:

A Non-interventional Study Evaluating Well-being/Quality of Life in Schizophrenic Patients Treated With Seroquel XR® (Quetiapine) and Other Atypical Antipsychotics.A 9-month, Observational, Multicentric Prospective Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689325
• Other study ID #: NIS-NNL-SER-2008/1
• Status: Completed
• Phase: N/A
• First received: May 29, 2008
• Last updated: October 26, 2010
• Start date: April 2008
• Est. completion date: January 2010

Study information

• Verified date: October 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

To evaluate the QOL (subjective effectiveness) in patients with schizophrenia, treated with atypical antipsychotics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of schizophrenia

• Treatment with one atypical antipsychotic* (for a first/new episode or a switch of therapy) for at least 2 weeks and maximum 8 weeks prior to the first study visit.

• Patient takes an AAP according to local SPC and current medical practice

• The patient must be able to understand and comply with the study requirements as judged by the investigator, e.g. patient must be able to read and write

Exclusion Criteria:

• Treatment with an additional AAP or AP to the initial prescribed AAP within the 2-8 weeks before the patient is included in the study

• Since the use of clozapine is limited, due to, among other things, the risk for agranulocytosis, patients on treatment with this '2nd line'AAP are excluded.

• Previous enrolment or treatment in the present NIS

• Known allergy to the prescribed AAP or any of its substances

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Netherlands	Research Site	Alphen
Netherlands	Research Site	Amersfoort
Netherlands	Research Site	Amstelveen
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Arnhem
Netherlands	Research Site	Bennebroek
Netherlands	Research Site	Boxmeer
Netherlands	Research Site	Breda
Netherlands	Research Site	Doetinchem
Netherlands	Research Site	Echt
Netherlands	Research Site	Enkhuizen
Netherlands	Research Site	Enschede
Netherlands	Research Site	Haarlem
Netherlands	Research Site	Halsteren
Netherlands	Research Site	Helmond
Netherlands	Research Site	Heythuizen
Netherlands	Research Site	Hoorn
Netherlands	Research Site	Kerkrade
Netherlands	Research Site	Kloetinge
Netherlands	Research Site	Leeuwarden
Netherlands	Research Site	Maastricht
Netherlands	Research Site	Nijmegen
Netherlands	Research Site	Oegstgeest
Netherlands	Research Site	Raalte
Netherlands	Research Site	Roermond
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Sluis
Netherlands	Research Site	Tiel
Netherlands	Research Site	Tilburg
Netherlands	Research Site	Utrecht
Netherlands	Research Site	Veenendaal
Netherlands	Research Site	Venray
Netherlands	Research Site	Vlaardingen
Netherlands	Research Site	Weert
Netherlands	Research Site	Zaandam
Netherlands	Research Site	Zoetermeer
Netherlands	Research Site	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Wellbeing under Neuroleptics' SWN-K-score; Change from baseline of QoL assessed by the SWN-K after 9 months of treatment with atypical antipsychotics.		At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation	No
Secondary	Positive And Negative Syndrome Scale-PANSS-8score		At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation	No
Secondary	Global Assessment of Functioning 'GAF' scale		At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation	No
Secondary	Disease insight; G-12 item of PANSS		At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation	No