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NCT00692133 Clinical Trial

Spanish Validation of Tool Questionnaire to Assess Patients´Perception About Antipsychotic Treatment

Schizophrenia Clinical Trial

— TOOL  

Official title:
Spanish Validation of Tool Questionnaire to Assess Patients´Perception About Antipsychotic Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00692133
Other study ID # NIS-NES-DUM-2007/2
Secondary ID
Status Completed
Phase N/A
First received June 5, 2008
Last updated December 8, 2010
Start date March 2008
Est. completion date August 2008

Study information
Verified date December 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Observational

Clinical Trial Summary

Non-interventional, prospective study to validate Spanish version of TOOL questionnaire in patients with schizophrenia and bipolar disorder under antipsychotic treatment

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Schizophrenia and bipolar disorder (DSM-IV criteria)

- Stabilized out-patients

- Treated with the same oral antipsychotic at least in the last month

Exclusion Criteria:

- Participation in another clinical trial within 6 months prior to enrolment into this study

- Administration of a depot antipsychotic medication

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Research Site Alcobendas Madrid
Spain Research Site Alzira Valencia
Spain Research Site Atarfe Granada
Spain Research Site Burgos
Spain Research Site Castellon
Spain Research Site Ceuta
Spain Research Site Coruna
Spain Research Site Elizondo Navarra
Spain Research Site Estepona Malaga
Spain Research Site Galdako Vizcaya
Spain Research Site Gava Barcelona
Spain Research Site Granada
Spain Research Site Leon
Spain Research Site Linares Jaen
Spain Research Site Madrid
Spain Research Site Malaga
Spain Research Site Mondragon Guipuzcoa
Spain Research Site Murcia
Spain Research Site Oviedo Asturias
Spain Research Site Palma Baleares
Spain Research Site Pamplona Navarra
Spain Research Site Parla Madrid
Spain Research Site Pontevedra
Spain Research Site Puerto Real Cadiz
Spain Research Site Sagunto Valencia
Spain Research Site Salamanca
Spain Research Site San Sebastian Guipuzcoa
Spain Research Site Santander Cantabria
Spain Research Site Tarragona
Spain Research Site Tudela Navarra
Spain Research Site Vitoria Alava
Spain Research Site Zamudio Vizcaya

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary TOOL questionnaire 15 days
Primary PANSS & Young Mania Scale 15 days
Secondary Montgomery Asberg Depression Scale 15 days
Secondary Euroqol 5D & SF-36D performed only at baseline visit
Secondary UKU modified scale performed only at baseline visit
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