SchizophreniaSerenityNCT00543088
Effectiveness of Anti-Psychotic in GPs Setting
An observational study of Schizophrenia and Bipolar Disorder, run by AstraZeneca at 57 sites in Belgium.
Trial summary
Evaluating the effectiveness of atypical antipsychotics in the community - a prospective, multicentre, observational study to evaluate the impact on Quality of Life of GP-based management of antipsychotic treatment in Belgium Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- How many people
- 250 participants
- Where
- 57 sitesBelgium
- Study dates
- Jan 2007to Jun 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Schizophrenia or Bipolar Disorder (currently in a manic episode)
Who cannot join
None listed.
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
Belgium57 sites
Research Site
Baudour
Research Site
Beyne-Heysay
Research Site
Bomal
Research Site
Bredene
Research Site
Brussels
Research Site
Esen
Research Site
Evere
Research Site
Gingelom
Research Site
Gouy-lez-Piéton
Research Site
Grâce-Hollogne
Research Site
Gullegem
Research Site
Harelbeke
Research Site
Harre
Research Site
Hotton
Research Site
Houtvenne
Research Site
Incourt
Research Site
Ixelles-Elsene
Research Site
Jalhay
Research Site
Jette
Research Site
Keumiée
Research Site
Lembeke
Research Site
Liège
Research Site
Limbourg
Research Site
Longueville
Research Site
Lovendegem
Research Site
Malmedy
Research Site
Mechelen
Research Site
Monceau-sur-Sambre
Research Site
Montignies-sur-Sambre
Research Site
Moorsel
Research Site
Moorseled
Research Site
Mouscron
Research Site
Namur
Research Site
Oostrozebeke
Research Site
Ostend
Research Site
Oudenaarde
Research Site
Poperinge
Research Site
Ransart
Research Site
Roux
Research Site
Ruisbroek
Research Site
Schaarbeek
Research Site
Spa
Research Site
Staden
Research Site
Theux
Research Site
Tilleur
Research Site
Torhout
Research Site
Tubize
Research Site
Verviers
Research Site
Veurne
Research Site
Wachtebeke
Research Site
Willebroek
Research Site
Wilrijk
Research Site
Woluwe-St-Lambert
Research Site
Zeebrugge
Research Site
Zichem
Research Site
Zomergem
Research Site
Zonnebeke
About this study
Official title: SERENITY: Evaluating the Effectiveness of Atypical Antipsychotics in the Community - a Prospective, Multicentre, Observational Study to Evaluate the Impact on Quality of Life of GP-Bases Management of Antipsychotic Treatment in Belgium.
Evaluating the effectiveness of atypical antipsychotics in the community - a prospective, multicentre, observational study to evaluate the impact on Quality of Life of GP-based management of antipsychotic treatment in Belgium
- Conditions
- Schizophrenia, Bipolar Disorder
- Keywords
- Schizophrenia, Bipolar Disorder, manic episode, atypical antipsychotic, Schizophrenia or Bipolar Disorder (currently in a manic episode)
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Mania
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the patient's functioning, by measuring the Quality of Life. Quality of Life will be assessed by the Q-LES-Q-16 (PRO).
Secondary outcomes (2)
The clinical efficacy & tolerability of atypical antipsychotics as assessed by the Clinical Global Impression(CGI) & Patient Global Impression of Change(PGIC)scores.
The wellbeing of the patients taking atypical antipsychotics as assessed by the Sheehan Disability Scale(SDS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startJan 2007
- Study completionJun 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
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pitchot W Pr, Principal investigator, ULg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543088
- Sponsor's protocol ID
- SRP-NB-SER-2006/1
- Acronym
- Serenity
- Status last verified
- Apr 2009
- First submitted
- 11 Oct 2007
- Last updated
- 23 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SERENITY: Evaluating the Effectiveness of Atypical Antipsychotics in the Community - a Prospective, Multicentre, Observational Study to Evaluate the Impact on Quality of Life of GP-Bases Management of Antipsychotic Treatment in Belgium.
- ClinicalTrials.gov ID
- NCT00543088
- Acronym / sponsor ID
- Serenity / SRP-NB-SER-2006/1
- Conditions
- Schizophrenia, Bipolar Disorder
- Keywords
- Schizophrenia, Bipolar Disorder, manic episode, atypical antipsychotic, Schizophrenia or Bipolar Disorder (currently in a manic episode)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Study completion
- Jun 2008 (actual)
- First posted
- 12 Oct 2007 (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.
Evaluating the effectiveness of atypical antipsychotics in the community - a prospective, multicentre, observational study to evaluate the impact on Quality of Life of GP-based management of antipsychotic treatment in Belgium
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with Schizophrenia or Bipolar Disorder (currently in a manic episode)
Key exclusion criteria (0 listed)
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
to evaluate the patient's functioning, by measuring the Quality of Life. Quality of Life will be assessed by the Q-LES-Q-16 (PRO).
2 secondary outcomes
The clinical efficacy & tolerability of atypical antipsychotics as assessed by the Clinical Global Impression(CGI) & Patient Global Impression of Change(PGIC)scores.
The wellbeing of the patients taking atypical antipsychotics as assessed by the Sheehan Disability Scale(SDS)
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 23 Apr 2009.
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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.
Pitchot W Pr principal investigator
ULg
57 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 57 sites in Belgium.
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 1 inclusion and 0 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 23 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Belgium. 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?
to evaluate the patient's functioning, by measuring the Quality of Life. Quality of Life will be assessed by the Q-LES-Q-16 (PRO).. 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 23 Apr 2009.