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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
Results First Received: October 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Bipolar Mania
Interventions: Drug: Quetiapine fumarate
Drug: lithium

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Seroquel XR

Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.

Treatment duration: 28 days

Seroquel XR + Lithium

Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].

Treatment duration: 28 days


Participant Flow:   Overall Study
    Seroquel XR     Seroquel XR + Lithium  
STARTED     67 [1]   64 [2]
COMPLETED     52     42  
NOT COMPLETED     15     22  
Lost to Follow-up                 0                 4  
Lack of Efficacy                 4                 2  
Death                 0                 1  
technical problum                 1                 0  
Adverse Event                 2                 3  
Withdrawal by Subject                 8                 11  
Wrongly randomization                 0                 1  
[1] Seroquel XR: 300mg
[2] Seroquel XR: 300mg Lithium: 900mg



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Seroquel XR

Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.

Treatment duration: 28 days

Seroquel XR + Lithium

Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].

Treatment duration: 28 days

Total Total of all reporting groups

Baseline Measures
    Seroquel XR     Seroquel XR + Lithium     Total  
Number of Participants  
[units: participants]
  63     58     121  
Age [1]
[units: Years]
Mean ± Standard Deviation
     
Age     38.4  ± 9.8     36.9  ± 11.7     37.7  ± 10.7  
Age, Customized [2]
[units: Years]
Mean ± Standard Deviation
     
Age at onset of acute bipolar mania     31.0  ± 10.6     30.0  ± 11.3     30.5  ± 10.9  
Gender [3]
[units: Number of patients in ITT analysis set]
     
Female     37     34     71  
Male     26     24     50  
Total No. of acute bipolar mania episodes over lifetime  
[units: Episodes]
Mean ± Standard Deviation
  4.24  ± 4.31     3.25  ± 2.42     3.76  ± 3.54  
Bipolar I Disorder [4]
[units: Number of Patients in ITT analysis set]
     
Manic Episodes     57     51     108  
Mixed Episodes     6     7     13  
[1] Age in ITT population.
[2] Age at onset of acute bipolar mania in ITT analysis set
[3] Total ITT analysis set is 121
[4] number of patients experiencing manic and mixed episodes in ITT analysis set



  Outcome Measures
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1.  Primary:   The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29   [ Time Frame: From Baseline to Day 29 ]

2.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Hui Jung Sin / Clinical Project Leader
Organization: SM&M Korea
phone: 82-2-2188-2165
e-mail: ClinicalTrialTransparency@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01254721     History of Changes
Other Study ID Numbers: D1443L00086
Study First Received: December 3, 2010
Results First Received: October 22, 2013
Last Updated: April 9, 2014
Health Authority: Korea: Institutional Review Board