Clinical trial NCT00782899: Four Dimensions in Schizophrenia
Official title: Prospective Observational Study About Progress of Subjective Well-being Sensation in Schizophrenic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
subjective well-being
depressive symptoms
schizophrenia course
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Months: 0, 1, 3 and 6
Secondary outcomes:
measure: Patient Clinical Impression
timeFrame: Months: 0, 1, 3 and 6
measure: Clinical evaluation and social performance
timeFrame: Months: 0, 1, 3 and 6
measure: Adverse events reported by patients
timeFrame: Months: 0, 1, 3 and 6
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Research Site
state: Alava
city: Almansa
country: Spain
facility: Research Site
state: Albacete
city: Alcoy
country: Spain
facility: Research Site
state: Alicante
city: Benidorm
country: Spain
facility: Research Site
state: Alicante
city: El Ejido
country: Spain
facility: Research Site
state: Almeria
city: Roquetas de mar
country: Spain
facility: Research Site
state: Almeria
city: Arriondas
country: Spain
facility: Research Site
state: Asturias
city: Aviles
country: Spain
facility: Research Site
state: Asturias
city: Gijon
country: Spain
facility: Research Site
state: Asturias
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Zafra
country: Spain
facility: Research Site
state: Badajoz
city: Manacor
country: Spain
facility: Research Site
state: Baleares
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Baleares
city: El Hospitalet de Llobregat
country: Spain
facility: Research Site
state: Barcelona
city: Gava
country: Spain
facility: Research Site
state: Barcelona
city: Manresa
country: Spain
facility: Research Site
state: Barcelona
city: Mataro
country: Spain
facility: Research Site
state: Barcelona
city: Sabadell
country: Spain
facility: Research Site
state: Barcelona
city: Sant Feliu de Llobregat
country: Spain
facility: Research Site
state: Barcelona
city: Santa Coloma de Gramanet
country: Spain
facility: Research Site
state: Barcelona
city: Terrasa
country: Spain
facility: Research Site
state: Barcelona
city: Aranda de Duero
country: Spain
facility: Research Site
state: Burgos
city: Maliano
country: Spain
facility: Research Site
state: Cantabria
city: Vinaros
country: Spain
facility: Research Site
state: Castellon
city: Renteria
country: Spain
facility: Research Site
state: Guipuzcoa
city: San Sebastian
country: Spain
facility: Research Site
state: Guipuzcoa
city: Alcala La Real
country: Spain
facility: Research Site
state: Jaen
city: Linares
country: Spain
facility: Research Site
state: Jaen
city: Logrono
country: Spain
facility: Research Site
state: La Rioja
city: Banaderos
country: Spain
facility: Research Site
state: Las Palmas
city: Montforte
country: Spain
facility: Research Site
state: Lugo
city: Alcala de Henares
country: Spain
facility: Research Site
state: Madrid
city: Colmenar Viejo
country: Spain
facility: Research Site
state: Madrid
city: Fuenlabrada
country: Spain
facility: Research Site
state: Madrid
city: Getafe
country: Spain
facility: Research Site
state: Madrid
city: Leganes
country: Spain
facility: Research Site
state: Madrid
city: Velez Malaga
country: Spain
facility: Research Site
state: Malaga
city: Caravaca de la Cruz
country: Spain
facility: Research Site
state: Murcia
city: Cartagena
country: Spain
facility: Research Site
state: Murcia
city: Elizondo
country: Spain
facility: Research Site
state: Navarra
city: Vigo
country: Spain
facility: Research Site
state: Pontevedra
city: Bejar
country: Spain
facility: Research Site
state: Salamanca
city: Alcala de Guadaira
country: Spain
facility: Research Site
state: Sevilla
city: Ecija
country: Spain
facility: Research Site
state: Sevilla
city: El Vendrell
country: Spain
facility: Research Site
state: Tarragona
city: Reus
country: Spain
facility: Research Site
state: Tarragona
city: Adeje
country: Spain
facility: Research Site
state: Tenerife
city: La Laguna
country: Spain
facility: Research Site
state: Tenerife
city: Santa Cruz de Tenerife
country: Spain
facility: Research Site
state: Tenerife
city: Adaia
country: Spain
facility: Research Site
state: Valencia
city: Catarroja
country: Spain
facility: Research Site
state: Valencia
city: Mislata
country: Spain
facility: Research Site
state: Valencia
city: Bilbao
country: Spain
facility: Research Site
state: Vizcaya
city: Alicante
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Caceres
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Soria
country: Spain
facility: Research Site
city: Toledo
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
References: