Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia

Completed

• Conditions: Schizophrenia

• Registration Number: NCT01160679
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-07
• Study First Submitted QC: 2010-07-09
• Study First Posted: 2010-07-12
• Study Start: 2010-08
• Status Verified: 2011-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2011-08-17
• Last Update Posted: 2011-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of total score of SHAPS	At 12 weeks

Secondary Outcome Measures

Name	Time	Method
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 12 weeks
Changes of Clinical Global Impression (CGI)-Severity score	At 12 weeks
The mean change MADRS total score	At 12 weeks

Trial Locations

Locations (1)

Research Site; 🇰🇷 Seoul, Korea, Republic of