Four Dimensions in Schizophrenia (4D)
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Details and patient eligibility
About
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.
Enrollment
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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
Trial design
320 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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