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Completed

NCT Number: NCT00782899

Four Dimensions in Schizophrenia

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.

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Key information

Conditions

Schizophrenia Behavior Behavioral Symptoms Depression Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Vitoria-Gasteiz, Alava, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: 4D

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 31, 2008
Registry last updated
Dec 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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