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Four Dimensions in Schizophrenia (4D)

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ClinicalTrials.gov Identifier: NCT00782899
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : December 10, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Schizophrenia

Study Design

Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study About Progress of Subjective Well-being Sensation in Schizophrenic Patients
Study Start Date : October 2008
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
Schizophrenic patients with a acute episode treated in outpatients clinics


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782899


  Show 65 Study Locations
Sponsors and Collaborators
AstraZeneca
More Information

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
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: December 2009

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders