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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 Score

The 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

Page last updated: August 23, 2015

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