Four Dimensions in Schizophrenia (4D)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00782899
First received: October 30, 2008
Last updated: December 8, 2010
Last verified: December 2009
  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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782899

  Show 65 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

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 July 26, 2014