Four Dimensions in Schizophrenia

Prospective Observational Study About Progress of Subjective Well-being Sensation in Schizophrenic Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00782899

Acronym

Enrollment

320

Registered

2008-10-31

Start date

2008-10-31

Completion date

2009-09-30

Last updated

2010-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, subjective well-being, depressive symptoms, schizophrenia course

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Spain

Outcome results