Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia

NCT ID: NCT01160679

Last Updated: 2011-08-18

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

231 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-08-31

Brief Summary

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This prospective, multi-center, 12 weeks naturalistic NIS trial will be conducted in 25 hospitals in naturalistic treatment setting. There will be no experimental component associated with this study and all observational activities have to be part of routine care visit: baseline (week 0), week 4 and week 12.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Documented clinical diagnosis of schizophrenia meeting the Diagnostic and Statistical Manual of Mental Disorders,(DSM-IV-TR) criteria
* Patients who already take one atypical at inclusion it is started at least 1 week and up to 4 weeks before the inclusion

Exclusion Criteria

* Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I
* Patients with antipsychotic combinations (more than two agents)
* Patients who are already on any mood stabilizers and antidepressant
* Known lack of response to clozapine or treatment with clozapine within 4 weeks prior to enrollment
* Patients who have been treated with antipsychotics in depot formulations for the last two months
* Previous enrollment or randomisation of treatment in the present NIS
* Patients who had participated in other clinical trials within 4 weeks prior to enrollment period
* Pregnant women or women who are breast-feeding
Minimum Eligible Age

20 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

Principal Investigators

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Sang-Woo Han, MD, PhD

Role: STUDY_CHAIR

Department of Psychiatry

Locations

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Research Site

Busan, Busan, South Korea

Site Status

Research Site

Gongju, Chungcheongnam-do, South Korea

Site Status

Research Site

Daegu, Daegu, South Korea

Site Status

Research Site

Daejeon, Daejeon, South Korea

Site Status

Research Site

Chuncheon, Gangwon-do, South Korea

Site Status

Research Site

Anyang-si, Gyeonggi-do, South Korea

Site Status

Research Site

Bucheon-si, Gyeonggi-do, South Korea

Site Status

Research Site

Goyang-si, Gyeonggi-do, South Korea

Site Status

Research Site

Yongin-si, Gyeonggi-do, South Korea

Site Status

Research Site

Gyeongju, Gyeongsangbuk-do, South Korea

Site Status

Research Site

Changnyeong, Gyeongsangnam-do, South Korea

Site Status

Research Site

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NIS-NKR-SER-2010/1

Identifier Type: -

Identifier Source: org_study_id

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