Back to resultsA Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study (STAR)
Primary Purpose
Acute Bipolar Mania
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Quetiapine fumarate
lithium
Sponsored by
About this trial
This is an interventional treatment trial for Acute Bipolar Mania focused on measuring Acute bipolar mania, Seroquel XR, Seroquel XR plus lithium, Quetiapine fumarate
Eligibility Criteria
Inclusion Criteria:
- Female and/or male inpatients or outpatients, aged over 18 years and under 65 years
- Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
- YMRS total score =20 at enrollment and randomization (Day 1) Patients had a history of at least one manic episode that required hospitalization and/or treatment with a mood stabilizer or antipsychotic.
- Female patients must have a negative urine human chorionic gonadotropin (HCG) test at enrolment and must be using a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive
Exclusion Criteria:
- Pregnancy or lactation Meeting the criteria for any other (than bipolar disorder) DSM-IV Axis I diagnosis, concomitant organic mental disorder or mental retardation
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization/baseline
- Known intolerance or hypersensitivity to, or lack of response to previous treatment with quetiapine fumarate or lithium
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Seroquel XR tablet
Seroquel XR + lithium
Outcomes
Primary Outcome Measures
The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29
The Young Mania Rating Scale (YMRS) is an eleven-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Total score is summed of 11items. Total score rage is from 0 to 60 and the higher score represent a worse oucome.
Secondary Outcome Measures
The Change From Baseline up to Day 29 and Final Assessment in the Clinical Global Impression-Severity of Illness Scale (CGI-S)
The Severity of Illness scale (CGI-S) is scored to rate the patient's current clinical state. The score range is form 0 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".
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01254721
Brief Title
A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study
Acronym
STAR
Official Title
A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative, Phase 4 Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Difficulty of recruitment.
Study Start Date
December 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to compare the efficacy of Seroquel XR monotherapy compared with Seroquel XR plus lithium in the treatment of acute bipolar mania by evaluation of the changes from baseline in Young Mania Ratings Scale (YMRS) total score to Day 29 using the last observation carried forward method.
Detailed Description
A comparison of the effectiveness of Seroquel XR and Seroquel XR plus lithium in patients with acute bipolar mania: An open-label, randomized, parallel groups, rater-blinded, 4 week, multicenter, comparative, phase 4 study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bipolar Mania
Keywords
Acute bipolar mania, Seroquel XR, Seroquel XR plus lithium, Quetiapine fumarate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Seroquel XR tablet
Arm Title
2
Arm Type
Active Comparator
Arm Description
Seroquel XR + lithium
Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate
Intervention Description
eXtended Release(XR) 50mg, 200mg, 300mg and/or 400mg tablet, oral, once daily in the evening, from assignment to the end of the study.
Intervention Type
Drug
Intervention Name(s)
lithium
Intervention Description
300mg tablet, oral
Primary Outcome Measure Information:
Title
The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29
Description
The Young Mania Rating Scale (YMRS) is an eleven-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Total score is summed of 11items. Total score rage is from 0 to 60 and the higher score represent a worse oucome.
Time Frame
From Baseline to Day 29
Secondary Outcome Measure Information:
Title
The Change From Baseline up to Day 29 and Final Assessment in the Clinical Global Impression-Severity of Illness Scale (CGI-S)
Description
The Severity of Illness scale (CGI-S) is scored to rate the patient's current clinical state. The score range is form 0 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".
Time Frame
From Baseline to Day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female and/or male inpatients or outpatients, aged over 18 years and under 65 years
Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
YMRS total score =20 at enrollment and randomization (Day 1) Patients had a history of at least one manic episode that required hospitalization and/or treatment with a mood stabilizer or antipsychotic.
Female patients must have a negative urine human chorionic gonadotropin (HCG) test at enrolment and must be using a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive
Exclusion Criteria:
Pregnancy or lactation Meeting the criteria for any other (than bipolar disorder) DSM-IV Axis I diagnosis, concomitant organic mental disorder or mental retardation
Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization/baseline
Known intolerance or hypersensitivity to, or lack of response to previous treatment with quetiapine fumarate or lithium
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeon Ho Joo
Organizational Affiliation
Asan Medical Center, St. Asan medical center 86, Songpa-gu, Seoul Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Ansan
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
State/Province
Gyeongsangbuk-do
Country
Korea, Republic of
Facility Name
Research Site
City
Busan
State/Province
Gyeongsangnam-do
Country
Korea, Republic of
Facility Name
Research Site
City
Jinju
State/Province
Gyeongsangnam-do
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study
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