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
  Purpose

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.


Condition Intervention Phase
Acute Bipolar Mania
Drug: Quetiapine fumarate
Drug: lithium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 131
Study Start Date: December 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Seroquel XR tablet
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.
Active Comparator: 2
Seroquel XR + lithium
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254721

Locations
Korea, Republic of
Research Site
Ansan, Gyeonggi-do, Korea, Republic of
Research Site
Daegu, Gyeongsangbuk-do, Korea, Republic of
Research Site
Busan, Gyeongsangnam-do, Korea, Republic of
Research Site
Jinju, Gyeongsangnam-do, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Yeon Ho Joo Asan Medical Center, St. Asan medical center 86, Songpa-gu, Seoul Korea
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01254721     History of Changes
Other Study ID Numbers: D1443L00086
Study First Received: December 3, 2010
Last Updated: November 21, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by AstraZeneca:
Acute bipolar mania
Seroquel XR
Seroquel XR plus lithium
Quetiapine fumarate

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lithium
Quetiapine
Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014