Bipolar DisordersHARMONYNCT00888264
A NIS Evaluating the Treatment Patterns of Atypical Antipsychotics in Patients Diagnosed With Bipolar I or II Disorder
An observational study of Bipolar Disorders, run by AstraZeneca at 45 sites in Belgium.
Trial summary
The purpose of this NIS is to obtain data on how AAPs are used in DSM-IV-TR Bipolar I and II Disorder, in the course of a major depressive episode. Both the parameters of use of AAPs and clinical evaluation will be recorded and potential differences that may exist due to epidemiological factors or comorbidities will… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorders
- How many people
- 152 participants
- Where
- 45 sitesBelgium
- Study dates
- May 2009to Aug 2010
- 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
Study population: Outpatients (male or female), diagnosed with Bipolar I or II disorder, having presented or presenting a major depressive episode (according to DSM-IV-TR) with starting date of 6 months maximum before the inclusion.
Who may be able to join
- Outpatients, diagnosed with Bipolar I or II Disorder, having presented or presenting a major depressive episode (according to DSM-IV-TR) with a starting date of 6 months maximum before the inclusion.
- Current treatment with atypical antipsychotic(s) (AAP(s)) minimal 1 month and maximum 6 months prior to the first study visit
- Patient takes an AAP at an adequate therapeutic dose as indicated in the local Summary of Product Characteristics (SPC) and current medical practice
Who cannot join
- Patients diagnosed with Bipolar I or II, experiencing a hypomanic, manic or mixed episode at time of inclusion
- Pregnant or breastfeeding women, or women of childbearing potential not using a medical reliable method of contraception as stated in the SPC of the AAPs
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
Belgium45 sites
Research Site
Aarschot
Research Site
Afsnee
Research Site
Antwerp
Research Site
Asse
Research Site
Berchem
Research Site
Bertrix
Research Site
Bierbeek
Research Site
Bouge
Research Site
Bruges
Research Site
Brussels
Research Site
Dave
Research Site
Dendermonde
Research Site
Erpe Mere
Research Site
Geel
Research Site
Ghent
Research Site
Hasselt
Research Site
Ixelles-Elsene
Research Site
Kortenberg
Research Site
Kortrijk
Research Site
Laken
Research Site
Lebbeke
Research Site
Lede
Research Site
Leuven
Research Site
Libramont
Research Site
Liège
Research Site
Lierneux
Research Site
Lubbeek
Research Site
Malle
Research Site
Marchienne-au-Pont
Research Site
Mons
Research Site
Montignies-sur-Sambre
Research Site
Namur
Research Site
Ottignies
Research Site
Roselaere
Research Site
Saint Denijs Westrem
Research Site
Saint-Servais
Research Site
Sint-Josse-ten-Noode
Research Site
Sint-Martens-Latem
Research Site
Sint-Niklaas
Research Site
Sleidinge
Research Site
St-Truiden
Research Site
Tienen
Research Site
Tournai
Research Site
Zottegem
Research Site
Zoutleeuw
About this study
Official title: A 6 Month Observational Multicentric Prospective Study Observing the Use of Atypical Antipsychotics in Patients Diagnosed With Bipolar I or II Disorder, in the Course of a Major Depressive Episode
The purpose of this NIS is to obtain data on how AAPs are used in DSM-IV-TR Bipolar I and II Disorder, in the course of a major depressive episode. Both the parameters of use of AAPs and clinical evaluation will be recorded and potential differences that may exist due to epidemiological factors or comorbidities will be analyzed.
- Conditions
- Bipolar Disorders
- Keywords
- Antipsychotics, Bipolar Disorder, Depressive episodes, Bipolar I or II Disorders
- Medical subject headings
- Bipolar Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Details of any AAP prescribed 1 to 6 months prior to the first study visit:
Measured: 4 visits
Secondary outcomes (3)
Montgomery Asberg Depression Rating Scale (MADRS), a 10-point observer rating scale, used to assess the symptoms and severity of depression.
Measured: 4 visits
Young Mania Rating Scale (YMRS), an 11-point observer rating scale, used to assess the symptoms and severity of mania.
Measured: 4 visits
Remission rate for the major depressive episode, in progress at inclusion
Measured: At completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisordersStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888264
- Sponsor's protocol ID
- NIS-NBE-SER-2008/1
- Acronym
- HARMONY
- Status last verified
- Dec 2010
- First submitted
- 24 Apr 2009
- Last updated
- 22 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6 Month Observational Multicentric Prospective Study Observing the Use of Atypical Antipsychotics in Patients Diagnosed With Bipolar I or II Disorder, in the Course of a Major Depressive Episode
- ClinicalTrials.gov ID
- NCT00888264
- Acronym / sponsor ID
- HARMONY / NIS-NBE-SER-2008/1
- Conditions
- Bipolar Disorders
- Keywords
- Antipsychotics, Bipolar Disorder, Depressive episodes, Bipolar I or II Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 27 Apr 2009 (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.
The purpose of this NIS is to obtain data on how AAPs are used in DSM-IV-TR Bipolar I and II Disorder, in the course of a major depressive episode. Both the parameters of use of AAPs and clinical evaluation will be recorded and potential differences that may exist due to epidemiological factors or comorbidities will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients (male or female), diagnosed with Bipolar I or II disorder, having presented or presenting a major depressive episode (according to DSM-IV-TR) with starting date of 6 months maximum before the inclusion.
Key inclusion criteria (3 listed)
- Outpatients, diagnosed with Bipolar I or II Disorder, having presented or presenting a major depressive episode (according to DSM-IV-TR) with a starting date of 6 months maximum before the inclusion.
- Current treatment with atypical antipsychotic(s) (AAP(s)) minimal 1 month and maximum 6 months prior to the first study visit
- Patient takes an AAP at an adequate therapeutic dose as indicated in the local Summary of Product Characteristics (SPC) and current medical practice
Key exclusion criteria (2 listed)
- Patients diagnosed with Bipolar I or II, experiencing a hypomanic, manic or mixed episode at time of inclusion
- Pregnant or breastfeeding women, or women of childbearing potential not using a medical reliable method of contraception as stated in the SPC of the AAPs
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
Details of any AAP prescribed 1 to 6 months prior to the first study visit:
Time frame: 4 visits
3 secondary outcomes
Montgomery Asberg Depression Rating Scale (MADRS), a 10-point observer rating scale, used to assess the symptoms and severity of depression.
Time frame: 4 visits
Young Mania Rating Scale (YMRS), an 11-point observer rating scale, used to assess the symptoms and severity of mania.
Time frame: 4 visits
Remission rate for the major depressive episode, in progress at inclusion
Time frame: At completion
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 22 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.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorders, run by AstraZeneca at 45 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 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 22 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 45 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?
Details of any AAP prescribed 1 to 6 months prior to the first study visit: (time frame: 4 visits). 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 22 Dec 2010.