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Observational Study to Evaluate Efficacy and Remission Status for Schizophrenia Patients Under Atypical Treatment (QTP NIS)

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: December 15, 2008
Last updated: December 8, 2010
Last verified: December 2010
The objective of this study is to evaluate under routine clinical setting the efficacy and remission status from treatment of 2nd-generation antipsychotic in patients who is upon acute episode or not achieving remission under regular treatment from schizophrenia/schizoaffective disorder. This study will collect in real-life practice the severity of schizophrenia by Clinical Global Impression (CGI), also evaluate the criteria of schizophrenia remission applying 8 items of Positive and Negative Syndrome Scale (PANSS) from Andresen working group, the Montgomery and Asberg Depression Rating Scale (MADRS), and the Global Assessment of Functioning Scale (GAF). Side effect of movement disorder will be evaluated by Drug Induced Extrapyramidal Symptoms Scale (DIEPSS). Tolerability for treatment will be monitored by documenting spontaneous reports on adverse events as well as change in body weight.


Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Naturalistic Observational Study to Evaluate Efficacy of 2nd-generation Antipsychotics and Remission Status for Patients With Schizophrenia / Schizoaffective Disorder

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • CGI-Severity of illness (CGI-SI) [ Time Frame: Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4) ]

Secondary Outcome Measures:
  • CGI-Degree of change (CGI-DC) [ Time Frame: Visit 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4) ]
  • MADRS, GAF, DIEPSS [ Time Frame: Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4) ]
  • Remission status [ Time Frame: Visit 1(Day 0), 5(Week 4) ]

Enrollment: 490
Study Start Date: December 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Observational Group
All commercially available 2nd-generation antipsychotic with an indication of treating schizophrenia will be prescribed by the physician according to normal practices


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute episode (first or relapse), or upon revisit and identified not achieving remission of schizophrenia or schizoaffective disorder (according to remission criteria of schizophrenia)

Inclusion Criteria:

  • Patients with acute episode (first or relapse), or upon revisit and identified not achieving remission of schizophrenia or schizoaffective disorder (according to remission criteria of schizophrenia)
  • Male or female aged between 18 and 65 years
  • Patients recruited from both in-patient and out-patient clinics
  • Patients who are cooperative, by judgment from investigators, and the use of oral antipsychotic considered adequate

Exclusion Criteria:

  • Pregnancy or lactation
  • Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
  • Known intolerance, lack of response, or contraindication to prescribed atypical antipsychotic, as judged by the investigator
  • Administration of a depot antipsychotic injection within one dosing interval (for the depot) before enrolment and patients prescribed with clozapine within 3 months prior to enrolment
  Contacts and Locations
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Please refer to this study by its identifier: NCT00809731

Research Site
Changhua-Lugang, Taiwan
Research Site
Changhua, Taiwan
Research Site
Chiayi, Taiwan
Research Site
Kaohsiung-Niosong, Taiwan
Research Site
Kaohsiung-Sanmin, Taiwan
Research Site
Kaohsiung-Yanchao, Taiwan
Research Site
Keelung, Taiwan
Research Site
Miaoli-Toufen, Taiwan
Research Site
Miaoli, Taiwan
Research Site
Taichung-Beitun, Taiwan
Research Site
Taichung-Shalu, Taiwan
Research Site
Taipei-Banciao, Taiwan
Research Site
Taipei-Datong, Taiwan
Research Site
Taipei-Shilin, Taiwan
Research Site
Taipei-Shipai, Taiwan
Research Site
Taipei-Xindian, Taiwan
Research Site
Taoyuan, Taiwan
Sponsors and Collaborators
Principal Investigator: Yuan-Hwa Chou, MD, PhD Taipei Veterans General Hospital, Taiwan
  More Information

Responsible Party: Robin Meng/Marketing Company Medical Director, AstraZeneca Pharmaceuticals Identifier: NCT00809731     History of Changes
Other Study ID Numbers: NIS-NTW-SER-2008/1
Study First Received: December 15, 2008
Last Updated: December 8, 2010

Keywords provided by AstraZeneca:
Schizophrenia remission status by 8-item PANSS

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders processed this record on May 25, 2017