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

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00809731
• Lead Sponsor: AstraZeneca

Brief Summary

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

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-15
• Study First Submitted QC: 2008-12-16
• Study First Posted: 2008-12-17
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CGI-Severity of illness (CGI-SI)	Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)

Secondary Outcome Measures

Name	Time	Method
CGI-Degree of change (CGI-DC)	Visit 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)
MADRS, GAF, DIEPSS	Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)
Remission status	Visit 1(Day 0), 5(Week 4)

Trial Locations

Locations (1)

Research Site; 🇨🇳 Taoyuan, Taiwan