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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00692133
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : December 10, 2010
Information provided by:

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

Condition or disease
Schizophrenia Bipolar Disorder

Study Type : Observational
Estimated Enrollment : 250 participants
Time Perspective: Prospective
Official Title: Spanish Validation of Tool Questionnaire to Assess Patients´Perception About Antipsychotic Treatment
Study Start Date : March 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00692133

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

Responsible Party: Teresa Díez, AstraZeneca Pharmaceuticals Identifier: NCT00692133     History of Changes
Other Study ID Numbers: NIS-NES-DUM-2007/2
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: December 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