Quetiapine Efficacy in Bipolar Depression Study (QUEEN)

AstraZeneca

Status: Completed

Conditions: Bipolar Depression

Study type: Observational

Funder types: Industry

Identifiers

NCT00523601

NIS-NKR-SER-2007/2

Details and patient eligibility

About

To reassure the clinical study data on Seroquel antidepressant efficacy in patients who are diagnosed as bipolar depression

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent
• Meet DSM-IV-TR criteria for bipolar depression at the time of baseline

Exclusion criteria

• Since this programme intends to describe quetiapine use in routine clinical practice when prescribed as treatment of bipolar depression, there are no programme specific exclusion criteria, other than:

Or, any of the following is regarded as a criterion for exclusion from the programme:

1. Serious or unstable, medical illness. Subjects with chronic illness may be included but must be stable and otherwise physically healthy on the basis of a physical examination, medical history
2. Known intolerance for or lack of response to quetiapine, as judged by the investigator