Management of Index Episode in Patients With Bipolar Disorder Treated by Seroquel XR
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01029145
First received: December 8, 2009
Last updated: September 16, 2010
Last verified: September 2010
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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 May 21, 2013