Four Dimensions in Schizophrenia

NCT ID: NCT00782899

Last Updated: 2010-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Keywords

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Schizophrenia subjective well-being depressive symptoms schizophrenia course

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Schizophrenic patients with a acute episode treated in outpatients clinics

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Locations

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Research Site

Vitoria-Gasteiz, Alava, Spain

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Almansa, Albacete, Spain

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Alcoy, Alicante, Spain

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Alicante, Alicante, Spain

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Benidorm, Alicante, Spain

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El Ejido, Almeria, Spain

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Roquetas de Mar, Almeria, Spain

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Zafra, Badajoz, Spain

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Manacor, Balearic Islands, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Barcelona, Barcelona, Spain

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El Hospitalet de Llobregat, Barcelona, Spain

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Gavà, Barcelona, Spain

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Manresa, Barcelona, Spain

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Mataró, Barcelona, Spain

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Sabadell, Barcelona, Spain

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Sant Feliu de Llobregat, Barcelona, Spain

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Santa Coloma de Gramanet, Barcelona, Spain

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Terrassa, Barcelona, Spain

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Aranda de Duero, Burgos, Spain

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Cáceres, Caceres, Spain

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Maliaño, Cantabria, Spain

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Vinaròs, Castellon, Spain

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Donostia / San Sebastian, Guipuzcoa, Spain

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Errenteria, Guipuzcoa, Spain

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Alcalá la Real, Jaen, Spain

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Linares, Jaen, Spain

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Logroño, La Rioja, Spain

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Banaderos, Las Palmas, Spain

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Montforte, Lugo, Spain

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Alcalá de Henares, Madrid, Spain

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Colmenar Viejo, Madrid, Spain

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Fuenlabrada, Madrid, Spain

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Getafe, Madrid, Spain

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Leganés, Madrid, Spain

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Madrid, Madrid, Spain

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Málaga, Malaga, Spain

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Vélez-Málaga, Malaga, Spain

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Caravaca de La Cruz, Murcia, Spain

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Cartagena, Murcia, Spain

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Elizondo, Navarre, Spain

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Vigo, Pontevedra, Spain

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Arriondas, Principality of Asturias, Spain

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Avilés, Principality of Asturias, Spain

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Gijón, Principality of Asturias, Spain

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Oviedo, Principality of Asturias, Spain

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Béjar, Salamanca, Spain

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Salamanca, Salamanca, Spain

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Alcalá de Guadaira, Sevilla, Spain

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Écija, Sevilla, Spain

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Seville, Sevilla, Spain

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Soria, Soria, Spain

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El Vendrell, Tarragona, Spain

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Reus, Tarragona, Spain

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Adeje, Tenerife, Spain

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San Cristóbal de La Laguna, Tenerife, Spain

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Santa Cruz de Tenerife, Tenerife, Spain

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Toledo, Toledo, Spain

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Adaia, Valencia, Spain

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Catarroja, Valencia, Spain

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Mislata, Valencia, Spain

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Valencia, Valencia, Spain

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Valladolid, Valladolid, Spain

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Bilbao, Vizcaya, Spain

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Zaragoza, Zaragoza, Spain

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Countries

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Spain

Other Identifiers

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NIS-NES-DUM-2008/2

Identifier Type: -

Identifier Source: org_study_id