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Completed

NCT Number: NCT00692133

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

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

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Key information

Conditions

Schizophrenia Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Vitoria-Gasteiz, Alava, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. TOOL questionnaire

    Time frame: 15 days

  2. PANSS & Young Mania Scale

    Time frame: 15 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: TOOL

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 6, 2008
Registry last updated
Dec 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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