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
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Bipolar Mania
Intervention: Quetiapine fumarate (Seroquel XR) (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Joon Woo Bahn, Study Chair, Affiliation: AstraZeneca Won-Myong Bahk, MD, Principal Investigator, Affiliation: St.Mary's hospital, The Catholic University of Korea
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.
Clinical Details
Official title: 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
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The Proportion of Patients With Improvement From Baseline to Week 4 in Clinical Global Impression-Clinical Benefit Score (LOCF)
Secondary outcome: The Mean Change From Baseline to Week 4 in - YMRS (Young Mania Rating Scale) Total ScoreThe CGI-I (Clinical Global Impression-Improvement of Illness) Change From Baseline to Week 4 The Mean Change From Baseline to Week 4 in CGI-S (Clinical Global Impression-Severity of Illness) Score
Detailed description:
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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Research Site, Daejeon, Korea, Republic of
Research Site, Gyungbook, Korea, Republic of
Research Site, Naju, Korea, Republic of
Research Site, Seoul, Korea, Republic of
Research Site, Chunan, Choongnam, Korea, Republic of
Research Site, CheonAn, Chungcheongnam-do, Korea, Republic of
Research Site, Chuncheon, Gangwondo, Korea, Republic of
Research Site, Bucheon, Gueonggido, Korea, Republic of
Research Site, Suwon, Gyeonggi-do, Korea, Republic of
Research Site, Gyeongju, Gyeongsangbuk-do, Korea, Republic of
Research Site, Yongsan-gu, Seoul, Korea, Republic of
Additional Information
Starting date: June 2010
Last updated: April 11, 2012
|