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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01029145
First received: December 8, 2009
Last updated: September 16, 2010
Last verified: September 2010
  Purpose

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
Bipolar Disorder
New Occurred Episode

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Symptoms severity [ Time Frame: 10 weeks ( 4 times:baseline; at 2 weeks; 6 weeks;10 weeks ) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QoL/ quality of life [ Time Frame: twice in 10 weeks ( v1 and v4) ] [ Designated as safety issue: No ]

Enrollment: 537
Study Start Date: December 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Bipolar patients that experience a new episode of any type

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029145

Locations
Romania
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
Research Site
Tg Jiu, Gorj, Romania
Research Site
Miecurea Ciuc, Harghita, Romania
Research Site
Ludus, Mures, Romania
Research Site
Campina, Prahova, Romania
Research Site
Ploiesti, Prahova, Romania
Research Site
Lugoj, Timisoara, Romania
Research Site
Rm Valcea, Valcea, Romania
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Ozana Serban AstraZeneca
  More Information

No publications provided

Responsible Party: MC MD, AstraZeneca PHARMA SRL ROMANIA
ClinicalTrials.gov Identifier: NCT01029145     History of Changes
Other Study ID Numbers: NIS-NRO-SER-2009/1
Study First Received: December 8, 2009
Last Updated: September 16, 2010
Health Authority: Romania: Ethics Committee
Romania: National Medicines Agency

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

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 16, 2014