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

Completed

• Conditions: Schizophrenia; Bipolar Disorder

• Registration Number: NCT00692133
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Schizophrenia and bipolar disorder (DSM-IV criteria)
• Stabilized out-patients
• Treated with the same oral antipsychotic at least in the last month

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Exclusion Criteria

• Participation in another clinical trial within 6 months prior to enrolment into this study
• Administration of a depot antipsychotic medication

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TOOL questionnaire	15 days
PANSS & Young Mania Scale	15 days

Secondary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Scale	15 days
Euroqol 5D & SF-36D	performed only at baseline visit
UKU modified scale	performed only at baseline visit

Trial Locations

Locations (1)

Research Site; 🇪🇸 Tarragona, Spain