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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029145
• Other study ID #: NIS-NRO-SER-2009/1
• Status: Completed
• Phase: N/A
• First received: December 8, 2009
• Last updated: September 16, 2010
• Start date: December 2009
• Est. completion date: May 2010

Study information

• Verified date: September 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ethics CommitteeRomania: National Medicines Agency
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 537
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder
• New Occurred Episode

Locations

Country	Name	City	State
Romania	Research Site	Arad
Romania	Research Site	Bacau
Romania	Research Site	Bistrita	Bistrita Nasaud
Romania	Research Site	Botosani
Romania	Research Site	Braila
Romania	Research Site	Bucuresti
Romania	Research Site	Campina	Prahova
Romania	Research Site	Cluj Napoca
Romania	Research Site	Craiova	Dolj
Romania	Research Site	Galati
Romania	Research Site	Giurgiu
Romania	Research Site	Hunedoara
Romania	Research Site	Iasi
Romania	Research Site	Ludus	Mures
Romania	Research Site	Lugoj	Timisoara
Romania	Research Site	Miecurea Ciuc	Harghita
Romania	Research Site	Oradea
Romania	Research Site	Palazu Mare	Constanta
Romania	Research Site	Piatra Neamt
Romania	Research Site	Pitesti	Arges
Romania	Research Site	Ploiesti	Prahova
Romania	Research Site	Rm Valcea	Valcea
Romania	Research Site	Satu Mare
Romania	Research Site	Suceava
Romania	Research Site	Targoviste	Dambovita
Romania	Research Site	Tg Jiu	Gorj
Romania	Research Site	Tg Mures
Romania	Research Site	Timisoara
Romania	Research Site	Tulcea
Romania	Research Site	Turda	Cluj Napoca

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms severity		10 weeks ( 4 times:baseline; at 2 weeks; 6 weeks;10 weeks )	No
Secondary	QoL/ quality of life		twice in 10 weeks ( v1 and v4)	No