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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)

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: April 9, 2014
Last verified: April 2014

December 3, 2010
April 9, 2014
December 2010
October 2012   (final data collection date for primary outcome measure)
The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29 [ Time Frame: From Baseline to Day 29 ] [ Designated as safety issue: No ]
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.
  • 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 ]
Complete list of historical versions of study NCT01254721 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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".
  • 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 ]
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
April 2014

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