Four Dimensions in Schizophrenia

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00782899
• Lead Sponsor: AstraZeneca

Brief Summary

Observational, non-interventional, longitudinal, prospective,multicenter, open label (No treatment is involved). 4 assessment will be carried out , in months 0, 1, 3 and 6. The primary objective is to asses evolution of subjective well-being and depressive symptoms in schizophrenic patients for six months after an acute episode treated in outpatient psychiatric units. The primary endpoint is: Total score in Subjective Well-being under Neuroleptic treatment (SWN-K) and Calgary Depression Rating Scale (CDRS) scales in assessment after 6 months vs baseline. Secondary objectives include: To evaluate the relationship between subjective well-being and psychopathology, subjective clinical global impression, adverse events and compliance of treatment. Also to compare the clinical global impression of psychiatrist and patient. In addiction to know the clinical, social and demographic factors involve in the subjective well-being and patient clinical global impression.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-30
• Study First Posted: 2008-10-31
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2009-12
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Provision of written inform consent
• Diagnosed of Schizophrenia of Schizoaffective Disorder based on DSM-IV-TR
• With an acute episode or worsening of clinical status. Defined as change in clinical status that need a significant change in therapeutic plan.
• Able to understand and comply with requirements of the study

Exclusion Criteria

• Mental retardation
• Unstable somatic disease, that is not receiving adequate treatment, based on investigator opinion.
• To have been recruited in a clinical trial in the last 4 weeks
• To have planned the inclusion in a clinical trial during the follow-up of this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total score in Subjective Well-being under Neuroleptic treatment (SWN-K) and Calgary Depression Rating Scale (CDRS) scales in assessment after 6 months vs baseline	Months: 0, 1, 3 and 6

Secondary Outcome Measures

Name	Time	Method
Patient Clinical Impression	Months: 0, 1, 3 and 6
Clinical evaluation and social performance	Months: 0, 1, 3 and 6
Adverse events reported by patients	Months: 0, 1, 3 and 6

Trial Locations

Locations (1)

Research Site; 🇪🇸 Zaragoza, Spain