Clinical trial NCT00689325: Evaluating Subjective Well-being in Schizophrenic Patients Treated With quetiapineXR® and Other Atypical Antipsychotics
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
remission
subjective well-being and effectiveness
Quality of Life
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with schizophrenia treated with atypical antipsychotics (AAPs) to stay in remission

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


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation
Secondary outcomes:
measure: Positive And Negative Syndrome Scale-PANSS-8score
timeFrame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation
measure: Global Assessment of Functioning 'GAF' scale
timeFrame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation
measure: Disease insight; G-12 item of PANSS
timeFrame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation
Other outcomes:
Locations:
city: Alphen
country: Netherlands
facility: Research Site
city: Amersfoort
country: Netherlands
facility: Research Site
city: Amstelveen
country: Netherlands
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Arnhem
country: Netherlands
facility: Research Site
city: Bennebroek
country: Netherlands
facility: Research Site
city: Boxmeer
country: Netherlands
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Doetinchem
country: Netherlands
facility: Research Site
city: Echt
country: Netherlands
facility: Research Site
city: Enkhuizen
country: Netherlands
facility: Research Site
city: Enschede
country: Netherlands
facility: Research Site
city: Haarlem
country: Netherlands
facility: Research Site
city: Halsteren
country: Netherlands
facility: Research Site
city: Helmond
country: Netherlands
facility: Research Site
city: Heythuizen
country: Netherlands
facility: Research Site
city: Hoorn
country: Netherlands
facility: Research Site
city: Kerkrade
country: Netherlands
facility: Research Site
city: Kloetinge
country: Netherlands
facility: Research Site
city: Leeuwarden
country: Netherlands
facility: Research Site
city: Maastricht
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Oegstgeest
country: Netherlands
facility: Research Site
city: Raalte
country: Netherlands
facility: Research Site
city: Roermond
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Sluis
country: Netherlands
facility: Research Site
city: Tiel
country: Netherlands
facility: Research Site
city: Tilburg
country: Netherlands
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
city: Veenendaal
country: Netherlands
facility: Research Site
city: Venray
country: Netherlands
facility: Research Site
city: Vlaardingen
country: Netherlands
facility: Research Site
city: Weert
country: Netherlands
facility: Research Site
city: Zaandam
country: Netherlands
facility: Research Site
city: Zoetermeer
country: Netherlands
facility: Research Site
city: Zwolle
country: Netherlands
facility: Research Site
Study officials:
References: