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

NCT ID: NCT01029145

Last Updated: 2010-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

537 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Bipolar Disorder New Occurred Episode

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Bipolar patients that experience a new episode of any type

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca PHARMA SRL ROMANIA

Principal Investigators

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Ozana Serban

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Arad, Arad, Romania

Site Status

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Piteşti, Argeş, Romania

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Bacau, Bacău, Romania

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Bistriţa, Bistrița-Năsăud County, Romania

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Botoșani, Botoșani County, Romania

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Brăila, Brăila County, Romania

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Bucharest, București, Romania

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Cluj-Napoca, Cluj Napoca, Romania

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Turda, Cluj Napoca, Romania

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Palazu Mare, Constanța County, Romania

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Craiova, Dolj, Romania

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Târgovişte, Dâmbovița County, Romania

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Galati, Galați County, Romania

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Giurgiu, Giurgiu County, Romania

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Tg Jiu, Gorj County, Romania

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Miecurea Ciuc, Harghita County, Romania

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Hunedoara, Hunedoara County, Romania

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Iași, Iaşi, Romania

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Luduş, Mureș County, Romania

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Oradea, Oradea, Romania

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Piatra Neamţ, Piatra Neamt, Romania

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Câmpina, Prahova, Romania

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Ploieşti, Prahova, Romania

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Satu Mare, Satu Mare County, Romania

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Suceava, Suceava, Romania

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Tg Mures, Tg Mures, Romania

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Lugoj, Timisoara, Romania

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Timișoara, Timisoara, Romania

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Tulcea, Tulcea County, Romania

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Rm Valcea, Vâlcea County, Romania

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Countries

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Romania

Other Identifiers

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NIS-NRO-SER-2009/1

Identifier Type: -

Identifier Source: org_study_id