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Observational Study to Evaluate Efficacy and Remission Status for Schizophrenia Patients Under Atypical Treatment

NCT ID: NCT00809731

Last Updated: 2010-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

490 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Keywords

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Schizophrenia remission status by 8-item PANSS

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational Group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Yuan-Hwa Chou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

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Research Site

Changhua, , Taiwan

Site Status

Research Site

Changhua-Lugang, , Taiwan

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Research Site

Chiayi City, , Taiwan

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Research Site

Kaohsiung-Niosong, , Taiwan

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Research Site

Kaohsiung-Sanmin, , Taiwan

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Kaohsiung-Yanchao, , Taiwan

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Keelung, , Taiwan

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Research Site

Miaoli, , Taiwan

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Research Site

Miaoli-Toufen, , Taiwan

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Research Site

Taichung-Beitun, , Taiwan

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Research Site

Taichung-Shalu, , Taiwan

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Research Site

Taipei-Banciao, , Taiwan

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Research Site

Taipei-Datong, , Taiwan

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Research Site

Taipei-Shilin, , Taiwan

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Taipei-Shipai, , Taiwan

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Research Site

Taipei-Xindian, , Taiwan

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Research Site

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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NIS-NTW-SER-2008/1

Identifier Type: -

Identifier Source: org_study_id