Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia
PLEASURE
1 other identifier
observational
231
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2010
Shorter than P25 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2010
CompletedFirst Posted
Study publicly available on registry
July 12, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedAugust 18, 2011
August 1, 2011
1 year
July 7, 2010
August 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The change of total score of SHAPS
At baseline
The change of total score of SHAPS
At 12 weeks
Secondary Outcomes (7)
Changes of Clinical Global Impression (CGI)-Severity score
At baseline
Changes of Clinical Global Impression (CGI)-Severity score
At 12 weeks
Proportion of patients having a score of 1 or 2 in CGI-I score
At 12 weeks
Proportion of significantly improved patients in SHAPS total score (more than 30%)
At baseline
The mean change MADRS total score
At baseline
- +2 more secondary outcomes
Eligibility Criteria
Department of psychiatry of 25 hospitals
You may qualify if:
- Documented clinical diagnosis of schizophrenia meeting the Diagnostic and Statistical Manual of Mental Disorders,(DSM-IV-TR) criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (12)
Research Site
Busan, Busan, South Korea
Research Site
Gongju, Chungcheongnam-do, South Korea
Research Site
Daegu, Daegu, South Korea
Research Site
Daejeon, Daejeon, South Korea
Research Site
Chuncheon, Gangwon-do, South Korea
Research Site
Anyang-si, Gyeonggi-do, South Korea
Research Site
Bucheon-si, Gyeonggi-do, South Korea
Research Site
Goyang-si, Gyeonggi-do, South Korea
Research Site
Yongin-si, Gyeonggi-do, South Korea
Research Site
Gyeongju, Gyeongsangbuk-do, South Korea
Research Site
Changnyeong, Gyeongsangnam-do, South Korea
Research Site
Seoul, Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sang-Woo Han, MD, PhD
Department of Psychiatry
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 7, 2010
First Posted
July 12, 2010
Study Start
August 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
August 18, 2011
Record last verified: 2011-08