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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 5, 2008

Last Updated Date

December 8, 2010

Start Date ^ICMJE

March 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

TOOL questionnaire [ Time Frame: 15 days ]
PANSS & Young Mania Scale [ Time Frame: 15 days ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00692133 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Montgomery Asberg Depression Scale [ Time Frame: 15 days ]
Euroqol 5D & SF-36D [ Time Frame: once ]
UKU modified scale [ Time Frame: once ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patient aged 18-year old or older who has been diagnosed as schizophrenia or bipolar disorder

Condition ^ICMJE

Schizophrenia
Bipolar Disorder

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

250

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00692133

Other Study ID Numbers ^ICMJE

NIS-NES-DUM-2007/2

Has Data Monitoring Committee

Responsible Party

Teresa Díez, AstraZeneca Pharmaceuticals

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Angel L Montejo

University of Salamanca

Information Provided By

AstraZeneca

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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