Four Dimensions in Schizophrenia

Schizophrenia Clinical Trial

— 4D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782899
• Other study ID #: NIS-NES-DUM-2008/2
• Status: Completed
• Phase: N/A
• First received: October 30, 2008
• Last updated: December 8, 2010
• Start date: October 2008
• Est. completion date: September 2009

Study information

• Verified date: December 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Spain	Research Site	Adaia	Valencia
Spain	Research Site	Adeje	Tenerife
Spain	Research Site	Alcala de Guadaira	Sevilla
Spain	Research Site	Alcala de Henares	Madrid
Spain	Research Site	Alcala La Real	Jaen
Spain	Research Site	Alcoy	Alicante
Spain	Research Site	Alicante
Spain	Research Site	Almansa	Albacete
Spain	Research Site	Aranda de Duero	Burgos
Spain	Research Site	Arriondas	Asturias
Spain	Research Site	Aviles	Asturias
Spain	Research Site	Banaderos	Las Palmas
Spain	Research Site	Barcelona
Spain	Research Site	Bejar	Salamanca
Spain	Research Site	Benidorm	Alicante
Spain	Research Site	Bilbao	Vizcaya
Spain	Research Site	Caceres
Spain	Research Site	Caravaca de la Cruz	Murcia
Spain	Research Site	Cartagena	Murcia
Spain	Research Site	Catarroja	Valencia
Spain	Research Site	Colmenar Viejo	Madrid
Spain	Research Site	Ecija	Sevilla
Spain	Research Site	El Ejido	Almeria
Spain	Research Site	El Hospitalet de Llobregat	Barcelona
Spain	Research Site	El Vendrell	Tarragona
Spain	Research Site	Elizondo	Navarra
Spain	Research Site	Fuenlabrada	Madrid
Spain	Research Site	Gava	Barcelona
Spain	Research Site	Getafe	Madrid
Spain	Research Site	Gijon	Asturias
Spain	Research Site	La Laguna	Tenerife
Spain	Research Site	Leganes	Madrid
Spain	Research Site	Linares	Jaen
Spain	Research Site	Logrono	La Rioja
Spain	Research Site	Madrid
Spain	Research Site	Malaga
Spain	Research Site	Maliano	Cantabria
Spain	Research Site	Manacor	Baleares
Spain	Research Site	Manresa	Barcelona
Spain	Research Site	Mataro	Barcelona
Spain	Research Site	Mislata	Valencia
Spain	Research Site	Montforte	Lugo
Spain	Research Site	Oviedo	Asturias
Spain	Research Site	Palma de Mallorca	Baleares
Spain	Research Site	Renteria	Guipuzcoa
Spain	Research Site	Reus	Tarragona
Spain	Research Site	Roquetas de mar	Almeria
Spain	Research Site	Sabadell	Barcelona
Spain	Research Site	Salamanca
Spain	Research Site	San Sebastian	Guipuzcoa
Spain	Research Site	Sant Feliu de Llobregat	Barcelona
Spain	Research Site	Santa Coloma de Gramanet	Barcelona
Spain	Research Site	Santa Cruz de Tenerife	Tenerife
Spain	Research Site	Sevilla
Spain	Research Site	Soria
Spain	Research Site	Terrasa	Barcelona
Spain	Research Site	Toledo
Spain	Research Site	Valencia
Spain	Research Site	Valladolid
Spain	Research Site	Velez Malaga	Malaga
Spain	Research Site	Vigo	Pontevedra
Spain	Research Site	Vinaros	Castellon
Spain	Research Site	Vitoria	Alava
Spain	Research Site	Zafra	Badajoz
Spain	Research Site	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Months: 0, 1, 3 and 6	No
Secondary	Patient Clinical Impression		Months: 0, 1, 3 and 6	No
Secondary	Clinical evaluation and social performance		Months: 0, 1, 3 and 6	No
Secondary	Adverse events reported by patients		Months: 0, 1, 3 and 6	Yes