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NCT00523601 Clinical Trial

Quetiapine Efficacy in Bipolar Depression Study

Bipolar Depression Clinical Trial

— QUEEN  

Official title:
A 8-Week, Multicenter, Open-Label, Observational Study of the Efficacy of Quetiapine Fumarate (SEROQUEL) Immediate-Release Tablets in Adult Patients With Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00523601
Other study ID # NIS-NKR-SER-2007/2
Secondary ID
Status Completed
Phase N/A
First received August 29, 2007
Last updated October 3, 2008
Start date June 2007
Est. completion date December 2007

Study information
Verified date April 2008
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 2000
Est. completion date December 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Research Site Daejun Kwangyuk-si
Korea, Republic of Research Site Kyungki-do Suwon-si
Korea, Republic of Research Site Kyungki-do Goyang-si

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

See also
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Active, not recruiting NCT03641300 - Efficacy of Convulsive Therapies for Bipolar Depression N/A
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Terminated NCT01807741 - Asenapine for Bipolar Depression Phase 2
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Completed NCT00762268 - A Trial of SAMe for Treatment-Resistant Bipolar Depression N/A
Terminated NCT00566111 - Ceftriaxone in the Management of Bipolar Depression N/A
Terminated NCT00217217 - Low Field Magnetic Stimulation Treatment for Bipolar Depression Phase 3
Recruiting NCT04998773 - Efficacy and Biomarkers of Response of TBS in Treatment Resistant Depression N/A
Recruiting NCT04939649 - Ketamine as an Adjunctive Therapy for Major Depression (2) Phase 3
Completed NCT03658824 - Behavioural Activation for Bipolar Depression: A Case Series N/A
Suspended NCT03674671 - Ketamine Versus Electroconvulsive Therapy in Depression Phase 3
Recruiting NCT05340686 - Braining- Aerobic Physical Activity as Add on Treatment in Bipolar Depression N/A
Recruiting NCT05296356 - OSU6162 in Bipolar Depression (OBID) Phase 2
Recruiting NCT03711019 - Efficacy of Convulsive Therapies During Continuation N/A
Completed NCT02088580 - Feasibility and Tolerability of Adjunct Chronotherapy in Depressed Inpatients N/A
Terminated NCT00272025 - Treatment Resistant Bipolar Depression Phase 1

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