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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 (STAR)

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ClinicalTrials.gov Identifier: NCT01254721
Recruitment Status : Terminated (Difficulty of recruitment.)
First Posted : December 7, 2010
Results First Posted : May 8, 2014
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE December 3, 2010
First Posted Date  ICMJE December 7, 2010
Results First Submitted Date  ICMJE October 22, 2013
Results First Posted Date  ICMJE May 8, 2014
Last Update Posted Date May 8, 2014
Study Start Date  ICMJE December 2010
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2014)
The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29 [ Time Frame: From Baseline 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2010)
  • The changes in YMRS total score from baseline to Day 29 [ Time Frame: Visit 1 (Day<7) ]
  • The changes in YMRS total score from baseline to Day 29 [ Time Frame: Visit 2 (Day1) ]
  • The changes in YMRS total score from baseline to Day 29 [ Time Frame: Visit 3 (Day8) ]
  • The changes in YMRS total score from baseline to Day 29 [ Time Frame: Visit 4 (Day15) ]
  • The changes in YMRS total score from baseline to Day 29 [ Time Frame: Visit 5 (Day29) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2014)
The Change From Baseline up to Day 29 and Final Assessment in the Clinical Global Impression-Severity of Illness Scale (CGI-S) [ Time Frame: From Baseline to Day 29 ]
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".
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2010)
  • The percentage of patients with a =50% reduction from baseline in the YMRS total score at study endpoint [ Time Frame: Visit 1 (Day<7) ]
  • The percentage of patients with a =50% reduction from baseline in the YMRS total score at study endpoint [ Time Frame: Visit 2 (Day1) ]
  • The percentage of patients with a =50% reduction from baseline in the YMRS total score at study endpoint [ Time Frame: Visit 4 (Day8) ]
  • The percentage of patients with a =50% reduction from baseline in the YMRS total score at study endpoint [ Time Frame: Visit 5 (Day15) ]
  • The percentage of patients with a =50% reduction from baseline in the YMRS total score at study endpoint [ Time Frame: Visit 6 (Day29) ]
  • The percentage of patients with YMRS remission (defined as a YMRS score = 12) at Day 29 [ Time Frame: Visit 1 (Day<7) ]
  • The percentage of patients with YMRS remission (defined as a YMRS score = 12) at Day 29 [ Time Frame: Visit 2 (Day1) ]
  • The percentage of patients with YMRS remission (defined as a YMRS score = 12) at Day 29 [ Time Frame: Visit 4 (Day8) ]
  • The percentage of patients with YMRS remission (defined as a YMRS score = 12) at Day 29 [ Time Frame: Visit 5 (Day15) ]
  • The percentage of patients with YMRS remission (defined as a YMRS score = 12) at Day 29 [ Time Frame: Visit 6 (Day29) ]
  • The change from baseline to each assessment (observed cases) in the YMRS total score [ Time Frame: Visit 1 (Day<7) ]
  • The change from baseline to each assessment (observed cases) in the YMRS total score [ Time Frame: Visit 2 (Day1) ]
  • The change from baseline to each assessment (observed cases) in the YMRS total score [ Time Frame: Visit 4 (Day8) ]
  • The change from baseline to each assessment (observed cases) in the YMRS total score [ Time Frame: Visit 5 (Day15) ]
  • The change from baseline to each assessment (observed cases) in the YMRS total score [ Time Frame: Visit 6 (Day29) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Bipolar Mania
Intervention  ICMJE
  • Drug: Quetiapine fumarate
    eXtended Release(XR) 50mg, 200mg, 300mg and/or 400mg tablet, oral, once daily in the evening, from assignment to the end of the study.
  • Drug: lithium
    300mg tablet, oral
Study Arms  ICMJE
  • Experimental: 1
    Seroquel XR tablet
    Intervention: Drug: Quetiapine fumarate
  • Active Comparator: 2
    Seroquel XR + lithium
    Interventions:
    • Drug: Quetiapine fumarate
    • Drug: lithium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 21, 2012)
131
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2010)
220
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01254721
Other Study ID Numbers  ICMJE D1443L00086
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yeon Ho Joo Asan Medical Center, St. Asan medical center 86, Songpa-gu, Seoul Korea
PRS Account AstraZeneca
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP