Four Dimensions in Schizophrenia

Study Overview
=================
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.

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

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Schizophrenic patients with a acute episode treated in outpatients clinics | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, subjective well-being, depressive symptoms, schizophrenia course