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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00809731
First received: December 15, 2008
Last updated: December 8, 2010
Last verified: December 2010
  Purpose

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
Schizophrenia

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CGI-Degree of change (CGI-DC) [ Time Frame: Visit 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4) ] [ Designated as safety issue: No ]
  • MADRS, GAF, DIEPSS [ Time Frame: Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4) ] [ Designated as safety issue: Yes ]
  • Remission status [ Time Frame: Visit 1(Day 0), 5(Week 4) ] [ Designated as safety issue: No ]

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

  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 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
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: NCT00809731

Locations
Taiwan
Research Site
Changhua, Taiwan
Research Site
Changhua-Lugang, 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, Taiwan
Research Site
Miaoli-Toufen, 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

No publications provided

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
Study First Received: December 15, 2008
Last Updated: December 8, 2010
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board
Taiwan: National Bureau of Controlled Drugs

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014