Observational Study to Evaluate Efficacy and Remission Status for Schizophrenia Patients Under Atypical Treatment - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00809731

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

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	December 2008
Estimated Study Completion Date:	October 2009

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809731

Contacts

Contact: AstraZeneca Taiwan Clinical Study, Information

+886 2 2737 8681

dora.tai@astrazeneca.com

Locations

Taiwan
Research site	Recruiting
Taipei, Taiwan
Research site	Not yet recruiting
Keelung, Taiwan
Research site	Not yet recruiting
Hualien, Taiwan
Research site	Not yet recruiting
Miaoli, Taiwan
Research site	Not yet recruiting
Taoyuan, Taiwan
Research site	Not yet recruiting
Taichung, Taiwan
Research site	Not yet recruiting
Kaohsiung, Taiwan
Research site	Not yet recruiting
Chiayi, Taiwan
Research site	Not yet recruiting
Changhua, 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:	AstraZeneca Pharmaceuticals ( Robin Meng/Medical Director )
Study ID Numbers:	NIS-NTW-SER-2008/1
Study First Received:	December 15, 2008
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00809731 History of Changes
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

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009