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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: June 5, 2008
Last updated: December 8, 2010
Last verified: December 2010
Non-interventional, prospective study to validate Spanish version of TOOL questionnaire in patients with schizophrenia and bipolar disorder under antipsychotic treatment

Schizophrenia Bipolar Disorder

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Spanish Validation of Tool Questionnaire to Assess Patients´Perception About Antipsychotic Treatment

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • TOOL questionnaire [ Time Frame: 15 days ]
  • PANSS & Young Mania Scale [ Time Frame: 15 days ]

Secondary Outcome Measures:
  • Montgomery Asberg Depression Scale [ Time Frame: 15 days ]
  • Euroqol 5D & SF-36D [ Time Frame: performed only at baseline visit ]
  • UKU modified scale [ Time Frame: performed only at baseline visit ]

Estimated Enrollment: 250
Study Start Date: March 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient aged 18-year old or older who has been diagnosed as schizophrenia or bipolar disorder

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00692133

Research Site
Vitoria, Alava, Spain
Research Site
Oviedo, Asturias, Spain
Research Site
Palma, Baleares, Spain
Research Site
Gava, Barcelona, Spain
Research Site
Puerto Real, Cadiz, Spain
Research Site
Santander, Cantabria, Spain
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Atarfe, Granada, Spain
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Mondragon, Guipuzcoa, Spain
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San Sebastian, Guipuzcoa, Spain
Research Site
Linares, Jaen, Spain
Research Site
Alcobendas, Madrid, Spain
Research Site
Parla, Madrid, Spain
Research Site
Estepona, Malaga, Spain
Research Site
Elizondo, Navarra, Spain
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Pamplona, Navarra, Spain
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Tudela, Navarra, Spain
Research Site
Alzira, Valencia, Spain
Research Site
Sagunto, Valencia, Spain
Research Site
Galdako, Vizcaya, Spain
Research Site
Zamudio, Vizcaya, Spain
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Burgos, Spain
Research Site
Castellon, Spain
Research Site
Ceuta, Spain
Research Site
Coruna, Spain
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Granada, Spain
Research Site
Leon, Spain
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Madrid, Spain
Research Site
Malaga, Spain
Research Site
Murcia, Spain
Research Site
Pontevedra, Spain
Research Site
Salamanca, Spain
Research Site
Tarragona, Spain
Sponsors and Collaborators
Study Chair: Angel L Montejo University of Salamanca
  More Information

Responsible Party: Teresa Díez, AstraZeneca Pharmaceuticals Identifier: NCT00692133     History of Changes
Other Study ID Numbers: NIS-NES-DUM-2007/2
Study First Received: June 5, 2008
Last Updated: December 8, 2010

Keywords provided by AstraZeneca:
bipolar disorder
antipsychotic treatment

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on August 21, 2017