Study Stopped
Poor recruitment
Study of the Broad Clinical Benefit for Seroquel XR With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current Therapy
RELEASE
A 4-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Broad Clinical Benefit for Seroquel XR (Quetiapine Fumarate Extended Release) With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current Therapy
1 other identifier
interventional
32
1 country
11
Brief Summary
The primary objective of this study is to evaluate the broad clinical benefit of dosing Seroquel XR with flexible in the treatment of acute bipolar mania patients with partial response to existing therapy. Clinical benefit will be assessed with the Clinical Global Impression-Clinical Benefit (CGI-CB) score, according to a classification based on the principles outlined in the CGI efficacy index. Improvement in clinical benefit will be defined as a decrease from baseline in CGI-CB.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2010
Shorter than P25 for phase_4
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2010
CompletedFirst Posted
Study publicly available on registry
May 21, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
April 10, 2012
CompletedApril 17, 2012
April 1, 2012
9 months
May 20, 2010
May 24, 2011
April 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Proportion of Patients With Improvement From Baseline to Week 4 in Clinical Global Impression-Clinical Benefit Score (LOCF)
CGI-CB is used to evaluate the investigator's global weighted impression of efficacy and interference of adverse event from baseline to every visit. Improvement in clinical benefit is defined as a decrease from baseline in CGI-CB. Rank 1 denotes best possible benefit from new treatment and rank 10 indicates that there is no benefit from treatment.
Baseline, week 4
Secondary Outcomes (3)
The Mean Change From Baseline to Week 4 in - YMRS (Young Mania Rating Scale) Total Score
Baseline, week 4
The CGI-I (Clinical Global Impression-Improvement of Illness) Change From Baseline to Week 4
Baseline, week 4
The Mean Change From Baseline to Week 4 in CGI-S (Clinical Global Impression-Severity of Illness) Score
Baseline, week 4
Study Arms (1)
Quetiapine XR
EXPERIMENTALQuetiapine fumarate (Seroquel XR)
Interventions
Extended Release(XR) 50 mg, 200 mg, 300 mg and/or 400 mg tablet, oral, once daily in the evening, from assignment to the end of the study.
Eligibility Criteria
You may qualify if:
- Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (1. Bipolar I Disorder, manic or mixed type with/without psychotic feature, 2. Diagnosis should be confirmed by the Mini Inte)
- Currently on Lithium/Valproate without antipsychotics more than 3 weeks consecutive treatment YMRS total score ≥16 at study entry
You may not qualify if:
- Non-response to antipsychotic treatments for manic symptoms in previous episodes
- A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria (1. Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) \>8.5%, 2. Admitted to hospital for treatment of DM or DM related illness in past 12 weeks, etc)
- An absolute neutrophil count (ANC) of 1.5 x 10\^9 per liter
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (11)
Research Site
Junam, Choongnam, South Korea
Research Site
Cheonan, Chungcheongnam-do, South Korea
Research Site
Chuncheon, Gangwondo, South Korea
Research Site
Bucheon-si, Gueonggido, South Korea
Research Site
Suwon, Gyeonggi-do, South Korea
Research Site
Gyeongju, Gyeongsangbuk-do, South Korea
Research Site
Yongsan-gu, Seoul, South Korea
Research Site
Daejeon, South Korea
Research Site
Gyungbook, South Korea
Research Site
Naju, South Korea
Research Site
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
In March 2011, considering the low patient inclusion rate (32 patients recruited so far whereas study objective was 125 patients for 85 completers), the study was ended prematurely earlier than the planned date. No analysis was conducted afterwards.
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY CHAIR
Joon Woo Bahn
AstraZeneca
- PRINCIPAL INVESTIGATOR
Won-Myong Bahk, MD
St.Mary's hospital, The Catholic University of Korea
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2010
First Posted
May 21, 2010
Study Start
June 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
April 17, 2012
Results First Posted
April 10, 2012
Record last verified: 2012-04