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Management of Index Episode in Patients With Bipolar Disorder Treated by Seroquel XR | Clinical Trials | Clareo Health

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

Non-interventional Study to obSERve currENt Management of Index Episode in Patients With Bipolar Disorder Treated bY Seroquel XR

NCT01029145•AstraZeneca

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (30)

Research Site

Arad, Arad, Romania

Research Site

Piteşti, Argeş, Romania

Research Site

Bacau, Bacău, Romania

Research Site

Bistriţa, Bistrița-Năsăud County, Romania

Research Site

Botoșani, Botoșani County, Romania

Research Site

Brăila, Brăila County, Romania

Research Site

Bucharest, București, Romania

Research Site

Cluj-Napoca, Cluj Napoca, Romania

Research Site

Turda, Cluj Napoca, Romania

Research Site

Palazu Mare, Constanța County, Romania

Key Dates

Start Date

December 1, 2009

Primary Completion Date

May 1, 2010

Completion Date

May 1, 2010

Last Updated

September 20, 2010

Enrollment

537

ACTUAL participants

Conditions

Bipolar DisorderNew Occurred Episode

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 20, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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