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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00689325
First received: May 29, 2008
Last updated: October 26, 2010
Last verified: October 2010
  Purpose

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


Condition
Schizophrenia

Study Type: Observational
Study Design: Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. [ Time Frame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive And Negative Syndrome Scale-PANSS-8score [ Time Frame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning 'GAF' scale [ Time Frame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation ] [ Designated as safety issue: No ]
  • Disease insight; G-12 item of PANSS [ Time Frame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation ] [ Designated as safety issue: No ]

Enrollment: 158
Study Start Date: April 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with schizophrenia treated with atypical antipsychotics (AAPs) to stay in remission

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689325

Locations
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, Netherlands
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: Hans Eriksson, Medical Science Sr Director, AstraZeneca, Medical Science, Wilmington USA
ClinicalTrials.gov Identifier: NCT00689325     History of Changes
Other Study ID Numbers: NIS-NNL-SER-2008/1
Study First Received: May 29, 2008
Last Updated: October 26, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by AstraZeneca:
Schizophrenia
remission
subjective well-being and effectiveness
Quality of Life

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014