Clinical trial NCT01128114: 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
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Bipolar Mania
Keywords: Acute bipolar mania
Seroquel XR
Quetiapine fumarate
Add-on therapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-05-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: The Proportion of Patients With Improvement From Baseline to Week 4 in Clinical Global Impression-Clinical Benefit Score (LOCF)
timeFrame: Baseline, week 4
Secondary outcomes:
measure: The Mean Change From Baseline to Week 4 in - YMRS (Young Mania Rating Scale) Total Score
timeFrame: Baseline, week 4
measure: The CGI-I (Clinical Global Impression-Improvement of Illness) Change From Baseline to Week 4
timeFrame: Baseline, week 4
measure: The Mean Change From Baseline to Week 4 in CGI-S (Clinical Global Impression-Severity of Illness) Score
timeFrame: Baseline, week 4
Other outcomes:
Locations:
city: Chunan
country: Korea, Republic of
facility: Research Site
state: Choongnam
city: CheonAn
country: Korea, Republic of
facility: Research Site
state: Chungcheongnam-do
city: Chuncheon
country: Korea, Republic of
facility: Research Site
state: Gangwondo
city: Bucheon
country: Korea, Republic of
facility: Research Site
state: Gueonggido
city: Suwon
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Gyeongju
country: Korea, Republic of
facility: Research Site
state: Gyeongsangbuk-do
city: Yongsan-gu
country: Korea, Republic of
facility: Research Site
state: Seoul
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Gyungbook
country: Korea, Republic of
facility: Research Site
city: Naju
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Joon Woo Bahn
role: STUDY_CHAIR
affiliation: St.Mary's hospital, The Catholic University of Korea
name: Won-Myong Bahk, MD
role: PRINCIPAL_INVESTIGATOR
References: