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Four Dimensions in Schizophrenia (4D)

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: October 30, 2008
Last updated: December 8, 2010
Last verified: December 2009
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.


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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Patient Clinical Impression [ Time Frame: Months: 0, 1, 3 and 6 ]
  • Clinical evaluation and social performance [ Time Frame: Months: 0, 1, 3 and 6 ]
  • Adverse events reported by patients [ Time Frame: Months: 0, 1, 3 and 6 ]

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)
Schizophrenic patients with a acute episode treated in outpatients clinics


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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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Please refer to this study by its identifier: NCT00782899

  Show 65 Study Locations
Sponsors and Collaborators
  More Information

Responsible Party: Teresa Díez, PhD, Local MC Neuroscience Therapeutic Area Manager, AstraZeneca Pharmaceuticals 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

Keywords provided by AstraZeneca:
subjective well-being
depressive symptoms
schizophrenia course

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders processed this record on May 23, 2017