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

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ClinicalTrials.gov Identifier: NCT00809731
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : December 9, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease
Schizophrenia

Study Design

Study Type : Observational
Actual Enrollment : 490 participants
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
Study Start Date : December 2008
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Observational Group
All commercially available 2nd-generation antipsychotic with an indication of treating schizophrenia will be prescribed by the physician according to normal practices


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809731


Locations
Taiwan
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
AstraZeneca
Investigators
Principal Investigator: Yuan-Hwa Chou, MD, PhD Taipei Veterans General Hospital, Taiwan
More Information

Responsible Party: Robin Meng/Marketing Company Medical Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00809731     History of Changes
Other Study ID Numbers: NIS-NTW-SER-2008/1
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: December 9, 2010
Last Verified: December 2010

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders