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OpenTrials
Completed

NCT Number: NCT00689325

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

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

Completed

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Alphen, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Acronym: Xperience

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 3, 2008
Registry last updated
Oct 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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