Four Dimensions in Schizophrenia (4D)
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Purpose
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.
| Condition |
|---|
|
Schizophrenia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective Observational Study About Progress of Subjective Well-being Sensation in Schizophrenic Patients |
- 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 [ Time Frame: Months: 0, 1, 3 and 6 ] [ Designated as safety issue: No ]
- Patient Clinical Impression [ Time Frame: Months: 0, 1, 3 and 6 ] [ Designated as safety issue: No ]
- Clinical evaluation and social performance [ Time Frame: Months: 0, 1, 3 and 6 ] [ Designated as safety issue: No ]
- Adverse events reported by patients [ Time Frame: Months: 0, 1, 3 and 6 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 320 |
| Study Start Date: | October 2008 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Schizophrenic patients with a acute episode treated in outpatients clinics
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Schizophrenic patients with a acute episode or worsening of clinical status treated in outpatients clinics. Defined acute episode or worsening as clinical status that need a significant change in the therapeutic plan.
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
Contacts and Locations
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No publications provided
| Responsible Party: | Teresa Díez, PhD, Local MC Neuroscience Therapeutic Area Manager, AstraZeneca Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00782899 History of Changes |
| Other Study ID Numbers: | NIS-NES-DUM-2008/2 |
| Study First Received: | October 30, 2008 |
| Last Updated: | December 8, 2010 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by AstraZeneca:
|
Schizophrenia subjective well-being depressive symptoms schizophrenia course |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013