Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia

Schizophrenia Clinical Trial

— PLEASURE  

Official title:

Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01160679
• Other study ID #: NIS-NKR-SER-2010/1
• Status: Completed
• Phase: N/A
• First received: July 7, 2010
• Last updated: August 17, 2011
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Anyang-si	Gyeonggi-do
Korea, Republic of	Research Site	Bucheon	Gyeonggi-do
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Changnyeong-gun	Gyeongsangnam-do
Korea, Republic of	Research Site	Chuncheon	Gangwon-do
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Daejeon
Korea, Republic of	Research Site	Gongju-si	Chungcheongnam-do
Korea, Republic of	Research Site	Goyang-si	Gyeonggi-do
Korea, Republic of	Research Site	Gyeongju-si	Gyeongsangbuk-do
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Yongin-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of total score of SHAPS		At baseline	No
Primary	The change of total score of SHAPS		At 12 weeks	No
Secondary	Changes of Clinical Global Impression (CGI)-Severity score		At baseline	No
Secondary	Changes of Clinical Global Impression (CGI)-Severity score		At 12 weeks	No
Secondary	Proportion of patients having a score of 1 or 2 in CGI-I score		At 12 weeks	No
Secondary	Proportion of significantly improved patients in SHAPS total score (more than 30%)		At baseline	No
Secondary	The mean change MADRS total score		At baseline	No
Secondary	The mean change MADRS total score		At 12 weeks	No
Secondary	Proportion of significantly improved patients in SHAPS total score (more than 30%)		At 12 weeks	No