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)

This study has been terminated.
(Difficulty of recruitment.)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01254721
First received: December 3, 2010
Last updated: November 21, 2012
Last verified: November 2012

December 3, 2010
November 21, 2012
December 2010
October 2012   (final data collection date for primary outcome measure)
  • The changes in YMRS total score from baseline to Day 29 [ Time Frame: Visit 1 (Day<7) ] [ Designated as safety issue: No ]
  • The changes in YMRS total score from baseline to Day 29 [ Time Frame: Visit 2 (Day1) ] [ Designated as safety issue: No ]
  • The changes in YMRS total score from baseline to Day 29 [ Time Frame: Visit 3 (Day8) ] [ Designated as safety issue: No ]
  • The changes in YMRS total score from baseline to Day 29 [ Time Frame: Visit 4 (Day15) ] [ Designated as safety issue: No ]
  • The changes in YMRS total score from baseline to Day 29 [ Time Frame: Visit 5 (Day29) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01254721 on ClinicalTrials.gov Archive Site
  • The percentage of patients with a =50% reduction from baseline in the YMRS total score at study endpoint [ Time Frame: Visit 1 (Day<7) ] [ Designated as safety issue: No ]
  • The percentage of patients with a =50% reduction from baseline in the YMRS total score at study endpoint [ Time Frame: Visit 2 (Day1) ] [ Designated as safety issue: No ]
  • The percentage of patients with a =50% reduction from baseline in the YMRS total score at study endpoint [ Time Frame: Visit 4 (Day8) ] [ Designated as safety issue: No ]
  • The percentage of patients with a =50% reduction from baseline in the YMRS total score at study endpoint [ Time Frame: Visit 5 (Day15) ] [ Designated as safety issue: No ]
  • The percentage of patients with a =50% reduction from baseline in the YMRS total score at study endpoint [ Time Frame: Visit 6 (Day29) ] [ Designated as safety issue: No ]
  • The percentage of patients with YMRS remission (defined as a YMRS score = 12) at Day 29 [ Time Frame: Visit 1 (Day<7) ] [ Designated as safety issue: No ]
  • The percentage of patients with YMRS remission (defined as a YMRS score = 12) at Day 29 [ Time Frame: Visit 2 (Day1) ] [ Designated as safety issue: No ]
  • The percentage of patients with YMRS remission (defined as a YMRS score = 12) at Day 29 [ Time Frame: Visit 4 (Day8) ] [ Designated as safety issue: No ]
  • The percentage of patients with YMRS remission (defined as a YMRS score = 12) at Day 29 [ Time Frame: Visit 5 (Day15) ] [ Designated as safety issue: No ]
  • The percentage of patients with YMRS remission (defined as a YMRS score = 12) at Day 29 [ Time Frame: Visit 6 (Day29) ] [ Designated as safety issue: No ]
  • The change from baseline to each assessment (observed cases) in the YMRS total score [ Time Frame: Visit 1 (Day<7) ] [ Designated as safety issue: No ]
  • The change from baseline to each assessment (observed cases) in the YMRS total score [ Time Frame: Visit 2 (Day1) ] [ Designated as safety issue: No ]
  • The change from baseline to each assessment (observed cases) in the YMRS total score [ Time Frame: Visit 4 (Day8) ] [ Designated as safety issue: No ]
  • The change from baseline to each assessment (observed cases) in the YMRS total score [ Time Frame: Visit 5 (Day15) ] [ Designated as safety issue: No ]
  • The change from baseline to each assessment (observed cases) in the YMRS total score [ Time Frame: Visit 6 (Day29) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Bipolar Mania
  • 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
  • Experimental: 1
    Seroquel XR tablet
    Intervention: Drug: Quetiapine fumarate
  • Active Comparator: 2
    Seroquel XR + lithium
    Interventions:
    • Drug: Quetiapine fumarate
    • Drug: lithium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
131
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01254721
D1443L00086
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Yeon Ho Joo Asan Medical Center, St. Asan medical center 86, Songpa-gu, Seoul Korea
AstraZeneca
November 2012

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