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

Acute Bipolar Mania Clinical Trial

— RELEASE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01128114
• Other study ID #: D1443L00080
• Status: Terminated
• Phase: Phase 4
• First received: May 20, 2010
• Last updated: April 11, 2012
• Start date: June 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Bipolar Mania

Intervention

Drug:
• Quetiapine fumarate (Seroquel XR)
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.

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Bucheon	Gueonggido
Korea, Republic of	Research Site	CheonAn	Chungcheongnam-do
Korea, Republic of	Research Site	Chunan	Choongnam
Korea, Republic of	Research Site	Chuncheon	Gangwondo
Korea, Republic of	Research Site	Daejeon
Korea, Republic of	Research Site	Gyeongju	Gyeongsangbuk-do
Korea, Republic of	Research Site	Gyungbook
Korea, Republic of	Research Site	Naju
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon	Gyeonggi-do
Korea, Republic of	Research Site	Yongsan-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The Mean Change From Baseline to Week 4 in - YMRS (Young Mania Rating Scale) Total Score	The YMRS is an 11-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure severity of manic episodes. There are 4 items graded on a 0 to 8 scale (irritability, speech, thought content, disruptive/aggressive behavior), and 7 items graded on 0 to 4 scale. These 4 items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Typical YMRS baseline scores can vary a lot. They depend on patients' clinical features such as mania (YMRS = 12), depression (YMRS = 3), or euthymia (YMRS = 2.	Baseline, week 4	No
Secondary	The CGI-I (Clinical Global Impression-Improvement of Illness) Change From Baseline to Week 4	The Global Improvement scale (CGI-I) is scored to rate the patient's change from baseline CGI. A CGI-I score of 1 indicates that a patient is "very much improved" and a score of 7 indicates that a patient is "very much worse." CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement. At all following visits CGI-I will also be rated. The following calculations will be made: Proportion of patients with CGI Global Improvement rating = 2 at Day 29	Baseline, week 4	No
Secondary	The Mean Change From Baseline to Week 4 in CGI-S (Clinical Global Impression-Severity of Illness) Score	The CGI-S is scored to rate patient's current clinical state. At enrolment patient's condition is rated using the CGI-S. At assignment CGI-S is again completed and a score of at least 4 (moderately ill). The score at assignment Day 1 will be regarded as the baseline value. At all following visits CGI-S will be rated. Each CGI item is scored on a scale from 1 to 7. A CGI-S score of 1 indicates that a patient is "Normal, not at all ill" and a score of 7 indicates that a patient is "Among the most extremely ill patients".	Baseline, week 4	No