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

September 16, 2010 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

537

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Arad, Romania
        • Research Site
      • Bacau, Romania
        • Research Site
      • Botosani, Romania
        • Research Site
      • Braila, Romania
        • Research Site
      • Bucuresti, Romania
        • Research Site
      • Cluj Napoca, Romania
        • Research Site
      • Galati, Romania
        • Research Site
      • Giurgiu, Romania
        • Research Site
      • Hunedoara, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
      • 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
        • Research Site
    • Arges
      • Pitesti, Arges, Romania
        • Research Site
    • Bistrita Nasaud
      • Bistrita, Bistrita Nasaud, Romania
        • Research Site
    • Cluj Napoca
      • Turda, Cluj Napoca, Romania
        • Research Site
    • Constanta
      • Palazu Mare, Constanta, Romania
        • Research Site
    • Dambovita
      • Targoviste, Dambovita, Romania
        • Research Site
    • Dolj
      • Craiova, Dolj, Romania
        • Research Site
    • Gorj
      • Tg Jiu, Gorj, Romania
        • Research Site
    • Harghita
      • Miecurea Ciuc, Harghita, Romania
        • Research Site
    • Mures
      • Ludus, Mures, Romania
        • Research Site
    • Prahova
      • Campina, Prahova, Romania
        • Research Site
      • Ploiesti, Prahova, Romania
        • Research Site
    • Timisoara
      • Lugoj, Timisoara, Romania
        • Research Site
    • Valcea
      • Rm Valcea, Valcea, Romania
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Bipolar patients that experience a new episode of any type

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptoms severity
Time Frame: 10 weeks ( 4 times:baseline; at 2 weeks; 6 weeks;10 weeks )
10 weeks ( 4 times:baseline; at 2 weeks; 6 weeks;10 weeks )

Secondary Outcome Measures

Outcome Measure
Time Frame
QoL/ quality of life
Time Frame: twice in 10 weeks ( v1 and v4)
twice in 10 weeks ( v1 and v4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Ozana Serban, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

December 8, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

September 20, 2010

Last Update Submitted That Met QC Criteria

September 16, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NRO-SER-2009/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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