SchizophreniaTOOLNCT00692133
Spanish Validation of Tool Questionnaire to Assess Patients´Perception About Antipsychotic Treatment
An observational study of Schizophrenia and Bipolar Disorder, run by AstraZeneca at 32 sites in Spain.
Trial summary
Non-interventional, prospective study to validate Spanish version of TOOL questionnaire in patients with schizophrenia and bipolar disorder under antipsychotic treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- How many people
- 250 participants
- Where
- 32 sitesSpain
- Study dates
- Mar 2008to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient aged 18-year old or older who has been diagnosed as schizophrenia or bipolar disorder
Who may be able to join
- Schizophrenia and bipolar disorder (DSM-IV criteria)
- Stabilized out-patients
- Treated with the same oral antipsychotic at least in the last month
Who cannot join
- Participation in another clinical trial within 6 months prior to enrolment into this study
- Administration of a depot antipsychotic medication
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Spain32 sites
Research Site
A Coruña, Coruna
Research Site
Alcobendas, Madrid
Research Site
Alzira, Valencia
Research Site
Arrasate / Mondragón, Guipuzcoa
Research Site
Atarfe, Granada
Research Site
Burgos, Burgos
Research Site
Castellon, Castellon
Research Site
Ceuta, Ceuta
Research Site
Donostia / San Sebastian, Guipuzcoa
Research Site
Elizondo, Navarre
Research Site
Estepona, Malaga
Research Site
Galdako, Vizcaya
Research Site
Gavà, Barcelona
Research Site
Granada, Granada
Research Site
León, Leon
Research Site
Linares, Jaen
Research Site
Madrid, Madrid
Research Site
Málaga, Malaga
Research Site
Murcia, Murcia
Research Site
Oviedo, Principality of Asturias
Research Site
Palma, Balearic Islands
Research Site
Pamplona, Navarre
Research Site
Parla, Madrid
Research Site
Pontevedra, Pontevedra
Research Site
Puerto Real, Cadiz
Research Site
Sagunto, Valencia
Research Site
Salamanca, Salamanca
Research Site
Santander, Cantabria
Research Site
Tarragona, Tarragona
Research Site
Tudela, Navarre
Research Site
Vitoria-Gasteiz, Alava
Research Site
Zamudio, Vizcaya
About this study
Non-interventional, prospective study to validate Spanish version of TOOL questionnaire in patients with schizophrenia and bipolar disorder under antipsychotic treatment
- Conditions
- Schizophrenia, Bipolar Disorder
- Keywords
- schizophrenia, bipolar disorder, antipsychotic treatment, patients´preferences
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
TOOL questionnaire
Measured: 15 days
PANSS & Young Mania Scale
Measured: 15 days
Secondary outcomes (3)
Montgomery Asberg Depression Scale
Measured: 15 days
Euroqol 5D & SF-36D
Measured: performed only at baseline visit
UKU modified scale
Measured: performed only at baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Angel L Montejo, Study chair, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692133
- Sponsor's protocol ID
- NIS-NES-DUM-2007/2
- Acronym
- TOOL
- Status last verified
- Dec 2010
- First submitted
- 5 Jun 2008
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Validation of Tool Questionnaire to Assess Patients´Perception About Antipsychotic Treatment
- ClinicalTrials.gov ID
- NCT00692133
- Acronym / sponsor ID
- TOOL / NIS-NES-DUM-2007/2
- Conditions
- Schizophrenia, Bipolar Disorder
- Keywords
- schizophrenia, bipolar disorder, antipsychotic treatment, patients´preferences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-interventional, prospective study to validate Spanish version of TOOL questionnaire in patients with schizophrenia and bipolar disorder under antipsychotic treatment
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient aged 18-year old or older who has been diagnosed as schizophrenia or bipolar disorder
Key inclusion criteria (3 listed)
- Schizophrenia and bipolar disorder (DSM-IV criteria)
- Stabilized out-patients
- Treated with the same oral antipsychotic at least in the last month
Key exclusion criteria (2 listed)
- Participation in another clinical trial within 6 months prior to enrolment into this study
- Administration of a depot antipsychotic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TOOL questionnaire
Time frame: 15 days
PANSS & Young Mania Scale
Time frame: 15 days
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angel L Montejo study chair
University of Salamanca
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Bipolar Disorder, run by AstraZeneca at 32 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TOOL questionnaire (time frame: 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2010.