Bipolar DisorderNCT01029145
Management of Index Episode in Patients With Bipolar Disorder Treated by Seroquel XR
An observational study of Bipolar Disorder and New Occurred Episode, run by AstraZeneca at 30 sites in Romania.
Trial summary
The primary purpose of the study is to explore management of symptomatology in patients with bipolar disorder that experience a new manic,depressive or mixed episode and are treated with Seroquel XR monotherapy/adjuctive, in routine clinical practice in Romania Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, New Occurred Episode
- How many people
- 537 participants
- Where
- 30 sitesRomania
- Study dates
- Dec 2009to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The programme will include patients with bipolar disorder currently experiencing a manic, mixed or depressed episode( named in the protocol the index episode) treated with Seroquel XR for 1 week
Who may be able to join
- Patients eligible for entry into the study, male and females, will have a diagnosis of bipolar disorder, as defined by DSM-IV-TR and the current episode, whether it is manic, depressed or mixed will be treated with Seroquel XR since 1 week before entering the programme.
- All eligible patients will be included in the programme provided they will receive information in advance and will sign consent to grant access to the data collected with regard to their condition during the observation interval proposed.
Who cannot join
- All the patients who have a known hypersensitivity to Seroquel XR/quetiapine or any of its excipients will not be included in this study.
- Concomitant medication, that could result in drug interactions and could jeopardize patient safety will be carefully considered before having the patient enrolled. Additionally, all precautions applicable for special category patients will be taken into account, as detailed in current valid Romanian SmPC.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Romania30 sites
Research Site
Arad, Arad
Research Site
Bacau, Bacău
Research Site
Bistriţa, Bistrița-Năsăud County
Research Site
Botoșani, Botoșani County
Research Site
Brăila, Brăila County
Research Site
Bucharest, Bucharest
Research Site
Câmpina, Prahova
Research Site
Cluj-Napoca, Cluj Napoca
Research Site
Craiova, Dolj
Research Site
Galati, Galați County
Research Site
Giurgiu, Giurgiu County
Research Site
Hunedoara, Hunedoara County
Research Site
Iași, Iaşi
Research Site
Luduş, Mureș County
Research Site
Lugoj, Timisoara
Research Site
Miecurea Ciuc, Harghita County
Research Site
Oradea, Oradea
Research Site
Palazu Mare, Constanța County
Research Site
Piatra Neamţ, Piatra Neamt
Research Site
Piteşti, Argeş
Research Site
Ploieşti, Prahova
Research Site
Rm Valcea, Vâlcea County
Research Site
Satu Mare, Satu Mare County
Research Site
Suceava, Suceava
Research Site
Targoviste, Dâmbovița County
Research Site
Tg Jiu, Gorj County
Research Site
Tg Mures, Tg Mures
Research Site
Timișoara, Timisoara
Research Site
Tulcea, Tulcea County
Research Site
Turda, Cluj Napoca
About this study
Official title: Non-interventional Study to obSERve currENt Management of Index Episode in Patients With Bipolar Disorder Treated bY Seroquel XR
The primary purpose of the study is to explore management of symptomatology in patients with bipolar disorder that experience a new manic,depressive or mixed episode and are treated with Seroquel XR monotherapy/adjuctive, in routine clinical practice in Romania
- Conditions
- Bipolar Disorder, New Occurred Episode
- Keywords
- Bipolar disorder, New occured episode: manic depressive or mixed
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Bipolar patients that experience a new episode of any type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms severity
Measured: 10 weeks ( 4 times:baseline; at 2 weeks; 6 weeks;10 weeks )
Secondary outcomes (1)
QoL/ quality of life
Measured: twice in 10 weeks ( v1 and v4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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
- 537 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ozana Serban, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029145
- Sponsor's protocol ID
- NIS-NRO-SER-2009/1
- Status last verified
- Sep 2010
- First submitted
- 8 Dec 2009
- Last updated
- 20 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study to obSERve currENt Management of Index Episode in Patients With Bipolar Disorder Treated bY Seroquel XR
- ClinicalTrials.gov ID
- NCT01029145
- Acronym / sponsor ID
- NIS-NRO-SER-2009/1
- Conditions
- Bipolar Disorder, New Occurred Episode
- Keywords
- Bipolar disorder, New occured episode: manic depressive or mixed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 9 Dec 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 primary purpose of the study is to explore management of symptomatology in patients with bipolar disorder that experience a new manic,depressive or mixed episode and are treated with Seroquel XR monotherapy/adjuctive, in routine clinical practice in Romania
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Bipolar patients that experience a new episode of any type |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The programme will include patients with bipolar disorder currently experiencing a manic, mixed or depressed episode( named in the protocol the index episode) treated with Seroquel XR for 1 week
Key inclusion criteria (2 listed)
- Patients eligible for entry into the study, male and females, will have a diagnosis of bipolar disorder, as defined by DSM-IV-TR and the current episode, whether it is manic, depressed or mixed will be treated with Seroquel XR since 1 week before entering the programme.
- All eligible patients will be included in the programme provided they will receive information in advance and will sign consent to grant access to the data collected with regard to their condition during the observation interval proposed.
Key exclusion criteria (2 listed)
- All the patients who have a known hypersensitivity to Seroquel XR/quetiapine or any of its excipients will not be included in this study.
- Concomitant medication, that could result in drug interactions and could jeopardize patient safety will be carefully considered before having the patient enrolled. Additionally, all precautions applicable for special category patients will be taken into account, as detailed in current valid Romanian SmPC.
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
Symptoms severity
Time frame: 10 weeks ( 4 times:baseline; at 2 weeks; 6 weeks;10 weeks )
1 secondary outcome
QoL/ quality of life
Time frame: twice in 10 weeks ( v1 and v4)
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 20 Sep 2010.
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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.
Ozana Serban study director
AstraZeneca
30 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 Disorder and New Occurred Episode, run by AstraZeneca at 30 sites in Romania.
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 2 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 20 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Romania. 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?
Symptoms severity (time frame: 10 weeks ( 4 times:baseline; at 2 weeks; 6 weeks;10 weeks )). 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 20 Sep 2010.