Management of Index Episode in Patients With Bipolar Disorder Treated by Seroquel XR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01029145
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : September 20, 2010
Information provided by:

Brief 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

Condition or disease
Bipolar Disorder New Occurred Episode

Study Type : Observational
Actual Enrollment : 537 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study to obSERve currENt Management of Index Episode in Patients With Bipolar Disorder Treated bY Seroquel XR
Study Start Date : December 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Bipolar patients that experience a new episode of any type

Primary Outcome Measures :
  1. Symptoms severity [ Time Frame: 10 weeks ( 4 times:baseline; at 2 weeks; 6 weeks;10 weeks ) ]

Secondary Outcome Measures :
  1. QoL/ quality of life [ Time Frame: twice in 10 weeks ( v1 and v4) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01029145

Research Site
Pitesti, Arges, Romania
Research Site
Bistrita, Bistrita Nasaud, Romania
Research Site
Turda, Cluj Napoca, Romania
Research Site
Palazu Mare, Constanta, Romania
Research Site
Targoviste, Dambovita, Romania
Research Site
Craiova, Dolj, Romania
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Tg Jiu, Gorj, Romania
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Miecurea Ciuc, Harghita, Romania
Research Site
Ludus, Mures, Romania
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Campina, Prahova, Romania
Research Site
Ploiesti, Prahova, Romania
Research Site
Lugoj, Timisoara, Romania
Research Site
Rm Valcea, Valcea, Romania
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Arad, Romania
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Bacau, Romania
Research Site
Botosani, Romania
Research Site
Braila, Romania
Research Site
Bucuresti, Romania
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Cluj Napoca, Romania
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Galati, Romania
Research Site
Giurgiu, Romania
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Hunedoara, Romania
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Iasi, Romania
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Oradea, Romania
Research Site
Piatra Neamt, Romania
Research Site
Satu Mare, Romania
Research Site
Suceava, Romania
Research Site
Tg Mures, Romania
Research Site
Timisoara, Romania
Research Site
Tulcea, Romania
Sponsors and Collaborators
Study Director: Ozana Serban AstraZeneca

Responsible Party: MC MD, AstraZeneca PHARMA SRL ROMANIA Identifier: NCT01029145     History of Changes
Other Study ID Numbers: NIS-NRO-SER-2009/1
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: September 20, 2010
Last Verified: September 2010

Keywords provided by AstraZeneca:
Bipolar disorder
New occured episode: manic depressive or mixed

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs