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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00692133
First received: June 5, 2008
Last updated: December 8, 2010
Last verified: December 2010
  Purpose

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


Condition
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
  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 ClinicalTrials.gov identifier: NCT00692133

Locations
Spain
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
Research Site
Atarfe, Granada, Spain
Research Site
Mondragon, Guipuzcoa, Spain
Research Site
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
Research Site
Pamplona, Navarra, Spain
Research Site
Tudela, Navarra, Spain
Research Site
Alzira, Valencia, Spain
Research Site
Sagunto, Valencia, Spain
Research Site
Galdako, Vizcaya, Spain
Research Site
Zamudio, Vizcaya, Spain
Research Site
Burgos, Spain
Research Site
Castellon, Spain
Research Site
Ceuta, Spain
Research Site
Coruna, Spain
Research Site
Granada, Spain
Research Site
Leon, Spain
Research Site
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
AstraZeneca
Investigators
Study Chair: Angel L Montejo University of Salamanca
  More Information

No publications provided

Responsible Party: Teresa Díez, AstraZeneca Pharmaceuticals
ClinicalTrials.gov 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
Health Authority: Spain: Ethics Committee

Keywords provided by AstraZeneca:
schizophrenia
bipolar disorder
antipsychotic treatment
patients´preferences

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014