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Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder (MANIA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00672490
First received: May 2, 2008
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
Results First Received: June 24, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Mania in Bipolar Disorder
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
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Reporting Groups
  Description
Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate 600 to 800 mg/day
Quetiapine Fumarate Used as Adjunct Therapy Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day

Participant Flow:   Overall Study
    Quetiapine Fumarate Used as Mono-Therapy     Quetiapine Fumarate Used as Adjunct Therapy  
STARTED     187     189  
COMPLETED     163     157  
NOT COMPLETED     24     32  
Withdrawal by Subject                 8                 8  
Lack of Compliance                      2                 7  
Mismatch Include/Exclude Criteria                 1                 0  
Adverse Event                 5                 8  
Violation of Concomitant Medicine                 1                 0  
Intolerance                 0                 2  
Lost to Follow-up                 1                 5  
No reason was provided                 6                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate 600 to 800 mg/day
Quetiapine Fumarate Used as Adjunct Therapy Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
Total Total of all reporting groups

Baseline Measures
    Quetiapine Fumarate Used as Mono-Therapy     Quetiapine Fumarate Used as Adjunct Therapy     Total  
Number of Participants  
[units: participants]
 		  187     189     376  
Age  
[units: years]
Mean ± Standard Deviation 		  34.3  ± 12.16     32.43  ± 11.14     33.36  ± 11.68  
Gender  
[units: Participants]
 		     
Female     94     87     181  
Male     93     102     195  



  Outcome Measures
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1.  Primary:   Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 28)   [ Time Frame: Baseline and 4 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in the Clinical Global Impressions for Bipolar Disorder Severity of Illness (CGI-BP-S) Score to Each Assessment (Day 28)   [ Time Frame: Baseline and 4 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score to Each Assessment (Day 28)   [ Time Frame: Baseline and 4 weeks ]
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4.  Secondary:   Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Each Assessment(Day 28)   [ Time Frame: Baseline and 4 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in the Young Mania Rating Scale (YMRS) Item 4 Score to Each Assessment   [ Time Frame: Baseline and 4 weeks ]
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Measure Type Secondary
Measure Title Change From Baseline in the Young Mania Rating Scale (YMRS) Item 4 Score to Each Assessment
Measure Description The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 4 (sleep) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Time Frame Baseline and 4 weeks  
Safety Issue No  

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.
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Reporting Groups
  Description
Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate 600 to 800 mg/day
Quetiapine Fumarate Used as Adjunct Therapy Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day

Measured Values
    Quetiapine Fumarate Used as Mono-Therapy     Quetiapine Fumarate Used as Adjunct Therapy  
Number of Participants Analyzed  
[units: participants]
 		  187     189  
Change From Baseline in the Young Mania Rating Scale (YMRS) Item 4 Score to Each Assessment  
[units: score on a scale]
Mean ± Standard Deviation 		  -2.0  ± 1.2     -2.1  ± 1.2  

No statistical analysis provided for Change From Baseline in the Young Mania Rating Scale (YMRS) Item 4 Score to Each Assessment



6.  Secondary:   Response Rate (Number of Patients With Clinically Response)   [ Time Frame: From Baseline to 4 weeks ]
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7.  Secondary:   Remission Rate (Number of Patients With Clinically Significant Remission)   [ Time Frame: From Baseline to 4 weeks ]
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8.  Secondary:   Treatment of Agitation (Change From Baseline in the PANSS Activation Subscale Score to Day 28)   [ Time Frame: Baseline and 4 weeks ]
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9.  Secondary:   Treatment of Aggression Risk (Change From Baseline in the PANSS Supplement Aggression Risk Subscale Score to Day 28)   [ Time Frame: Baseline and 4 weeks ]
  Show Outcome Measure 9


  Serious Adverse Events
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  Other Adverse Events
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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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00672490     History of Changes
Other Study ID Numbers: D1443L00023
Study First Received: May 2, 2008
Results First Received: June 24, 2010
Last Updated: June 11, 2012
Health Authority: China: Food and Drug Administration