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

December 8, 2009
September 16, 2010
December 2009
May 2010   (final data collection date for primary outcome measure)
Symptoms severity [ Time Frame: 10 weeks ( 4 times:baseline; at 2 weeks; 6 weeks;10 weeks ) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01029145 on ClinicalTrials.gov Archive Site
QoL/ quality of life [ Time Frame: twice in 10 weeks ( v1 and v4) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

  • Bipolar Disorder
  • New Occurred Episode
Not Provided
1
Bipolar patients that experience a new episode of any type
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
537
May 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
NCT01029145
NIS-NRO-SER-2009/1
No
MC MD, AstraZeneca PHARMA SRL ROMANIA
AstraZeneca
Not Provided
Study Director: Ozana Serban AstraZeneca
AstraZeneca
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP