Four Dimensions in Schizophrenia
4D
Prospective Observational Study About Progress of Subjective Well-being Sensation in Schizophrenic Patients
1 other identifier
observational
320
1 country
65
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2008
Shorter than P25 for all trials
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedDecember 10, 2010
December 1, 2009
11 months
October 30, 2008
December 8, 2010
Conditions
Keywords
Outcome Measures
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
Months: 0, 1, 3 and 6
Secondary Outcomes (3)
Patient Clinical Impression
Months: 0, 1, 3 and 6
Clinical evaluation and social performance
Months: 0, 1, 3 and 6
Adverse events reported by patients
Months: 0, 1, 3 and 6
Study Arms (1)
1
Schizophrenic patients with a acute episode treated in outpatients clinics
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (65)
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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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 30, 2008
First Posted
October 31, 2008
Study Start
October 1, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
December 10, 2010
Record last verified: 2009-12