Clinical trial NCT01029145: Management of Index Episode in Patients With Bipolar Disorder Treated by Seroquel XR
Official title: Non-interventional Study to obSERve currENt Management of Index Episode in Patients With Bipolar Disorder Treated bY Seroquel XR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
New Occurred Episode
Keywords: Bipolar disorder
New occured episode: manic depressive or mixed
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 537
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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 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.

Primary outcomes:
measure: Symptoms severity
timeFrame: 10 weeks ( 4 times:baseline; at 2 weeks; 6 weeks;10 weeks )
Secondary outcomes:
measure: QoL/ quality of life
timeFrame: twice in 10 weeks ( v1 and v4)
Other outcomes:
Locations:
city: Pitesti
country: Romania
facility: Research Site
state: Arges
city: Bistrita
country: Romania
facility: Research Site
state: Bistrita Nasaud
city: Turda
country: Romania
facility: Research Site
state: Cluj Napoca
city: Palazu Mare
country: Romania
facility: Research Site
state: Constanta
city: Targoviste
country: Romania
facility: Research Site
state: Dambovita
city: Craiova
country: Romania
facility: Research Site
state: Dolj
city: Tg Jiu
country: Romania
facility: Research Site
state: Gorj
city: Miecurea Ciuc
country: Romania
facility: Research Site
state: Harghita
city: Ludus
country: Romania
facility: Research Site
state: Mures
city: Campina
country: Romania
facility: Research Site
state: Prahova
city: Ploiesti
country: Romania
facility: Research Site
state: Prahova
city: Lugoj
country: Romania
facility: Research Site
state: Timisoara
city: Rm Valcea
country: Romania
facility: Research Site
state: Valcea
city: Arad
country: Romania
facility: Research Site
city: Bacau
country: Romania
facility: Research Site
city: Botosani
country: Romania
facility: Research Site
city: Braila
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj Napoca
country: Romania
facility: Research Site
city: Galati
country: Romania
facility: Research Site
city: Giurgiu
country: Romania
facility: Research Site
city: Hunedoara
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Piatra Neamt
country: Romania
facility: Research Site
city: Satu Mare
country: Romania
facility: Research Site
city: Suceava
country: Romania
facility: Research Site
city: Tg Mures
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Tulcea
country: Romania
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Ozana Serban
role: STUDY_DIRECTOR
References: