Clinical trial NCT00692133: Spanish Validation of Tool Questionnaire to Assess Patients´Perception About Antipsychotic Treatment
Official title: Spanish Validation of Tool Questionnaire to Assess Patients´Perception About Antipsychotic Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Bipolar Disorder
Keywords: schizophrenia
bipolar disorder
antipsychotic treatment
patients´preferences
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged 18-year old or older who has been diagnosed as schizophrenia or bipolar disorder

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


Eligibility criteria: 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

Primary outcomes:
measure: TOOL questionnaire
timeFrame: 15 days
measure: PANSS & Young Mania Scale
timeFrame: 15 days
Secondary outcomes:
measure: Montgomery Asberg Depression Scale
timeFrame: 15 days
measure: Euroqol 5D & SF-36D
timeFrame: performed only at baseline visit
measure: UKU modified scale
timeFrame: performed only at baseline visit
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Research Site
state: Alava
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Palma
country: Spain
facility: Research Site
state: Baleares
city: Gava
country: Spain
facility: Research Site
state: Barcelona
city: Puerto Real
country: Spain
facility: Research Site
state: Cadiz
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: Atarfe
country: Spain
facility: Research Site
state: Granada
city: Mondragon
country: Spain
facility: Research Site
state: Guipuzcoa
city: San Sebastian
country: Spain
facility: Research Site
state: Guipuzcoa
city: Linares
country: Spain
facility: Research Site
state: Jaen
city: Alcobendas
country: Spain
facility: Research Site
state: Madrid
city: Parla
country: Spain
facility: Research Site
state: Madrid
city: Estepona
country: Spain
facility: Research Site
state: Malaga
city: Elizondo
country: Spain
facility: Research Site
state: Navarra
city: Pamplona
country: Spain
facility: Research Site
state: Navarra
city: Tudela
country: Spain
facility: Research Site
state: Navarra
city: Alzira
country: Spain
facility: Research Site
state: Valencia
city: Sagunto
country: Spain
facility: Research Site
state: Valencia
city: Galdako
country: Spain
facility: Research Site
state: Vizcaya
city: Zamudio
country: Spain
facility: Research Site
state: Vizcaya
city: Burgos
country: Spain
facility: Research Site
city: Castellon
country: Spain
facility: Research Site
city: Ceuta
country: Spain
facility: Research Site
city: Coruna
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Leon
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Pontevedra
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: Tarragona
country: Spain
facility: Research Site
Study officials:
affiliation: University of Salamanca
name: Angel L Montejo
role: STUDY_CHAIR
References: