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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00689325

Acronym

Xperience

Enrollment

158

Registered

2008-06-03

Start date

2008-04-30

Completion date

2010-01-31

Last updated

2010-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, remission, subjective well-being and effectiveness, Quality of Life

Brief summary

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

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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
Global Assessment of Functioning 'GAF' scale	At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation
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

Countries

Netherlands

Outcome results