Adult Bipolar Mania

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00931723
First received: June 29, 2009
Last updated: March 27, 2012
Last verified: March 2012
Results First Received: November 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acute Mania
Interventions: Drug: Quetiapine fumarate XR
Drug: Lithium
Drug: Placebo

  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
This multicenter study was conducted between 24 June 2009 and 22 November 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study had an up to 28-day enrollment period (including a washout period lasting 7 to 28 days) and a 6-week double-blind treatment period. Patients were randomized to receive lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day or placebo+quetiapine XR 400 to 800 mg/day.

Reporting Groups
  Description
Lithium+Quetiapine XR Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
Placebo+Quetiapine XR Placebo+quetiapine XR 400 to 800 mg/day

Participant Flow:   Overall Study
    Lithium+Quetiapine XR     Placebo+Quetiapine XR  
STARTED     173     183  
COMPLETED     147     144  
NOT COMPLETED     26     39  
Withdrawal by Subject                 11                 13  
Adverse Event                 6                 13  
Lithium found in blood                 0                 1  
Condition under investigation worsened                 1                 2  
Lost to Follow-up                 1                 2  
Study-specific discontinuation criteria                 1                 1  
Severe non-compliance to protocol                 2                 0  
Safety reasons                 0                 1  
Took prohibited concomitant medication                 0                 1  
Lack or insufficient theraputic response                 2                 5  
Sponsor decision                 1                 0  
Late hospital discharge                 1                 0  



  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
Lithium+Quetiapine XR Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
Placebo+Quetiapine XR Placebo+quetiapine XR 400 to 800 mg/day
Total Total of all reporting groups

Baseline Measures
    Lithium+Quetiapine XR     Placebo+Quetiapine XR     Total  
Number of Participants  
[units: participants]
  173     183     356  
Age  
[units: Years]
Mean ± Standard Deviation
  37.9  ± 12.71     38.8  ± 12.09     38.3  ± 12.39  
Gender  
[units: Participants]
     
Female     72     62     134  
Male     101     121     222  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43)   [ Time Frame: Change in YMRS total score from baseline to Day 43. ]

2.  Secondary:   The Number of Patients With Clinically Significant Response.   [ Time Frame: 43 days (from baseline to Day 43) ]

3.  Secondary:   Remission   [ Time Frame: Days 8 to 43 ]

4.  Secondary:   Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness)   [ Time Frame: Change from baseline to Day 43. ]

5.  Secondary:   Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase)   [ Time Frame: Change from baseline to Day 43 ]

6.  Secondary:   Improvement of Overall Bipolar Illness   [ Time Frame: Day 43. ]

7.  Secondary:   Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: Change from baseline to Day 43. ]

8.  Secondary:   Change From Baseline to Day 43 in Positive and Negative Syndrome Scale (PANSS) Total Score   [ Time Frame: Change from baseline to Day 43 ]

9.  Secondary:   Change From Baseline to Day 43 in PANSS Activation Subscale Score   [ Time Frame: Change from baseline to Day 43 ]

10.  Secondary:   Change From Baseline to Day 43 in PANSS Positive Subscale Score   [ Time Frame: Change from baseline to Day 43 ]

11.  Secondary:   Change From Baseline to Day 43 in Each YMRS Item Score No. 1   [ Time Frame: Change from baseline to Day 43 ]

12.  Secondary:   Change From Baseline to Day 43 in Each YMRS Item Score No. 2   [ Time Frame: Change from baseline to Day 43 ]

13.  Secondary:   Change From Baseline to Day 43 in Each YMRS Item Score No. 3   [ Time Frame: Change from baseline to Day 43 ]

14.  Secondary:   Change From Baseline to Day 43 in Each YMRS Item Score No. 4   [ Time Frame: Change from baseline to Day 43 ]

15.  Secondary:   Change From Baseline to Day 43 in Each YMRS Item Score No. 5   [ Time Frame: Change from baseline to Day 43 ]

16.  Secondary:   Change From Baseline to Day 43 in Each YMRS Item Score No. 6   [ Time Frame: Change from baseline to Day 43 ]

17.  Secondary:   Change From Baseline to Day 43 in Each YMRS Item Score No. 7   [ Time Frame: Change from baseline to Day 43 ]

18.  Secondary:   Change From Baseline to Day 43 in Each YMRS Item Score No. 8   [ Time Frame: Change from baseline to Day 43 ]

19.  Secondary:   Change From Baseline to Day 43 in Each YMRS Item Score No. 9   [ Time Frame: Change from baseline to Day 43 ]

20.  Secondary:   Change From Baseline to Day 43 in Each YMRS Item Score No. 10   [ Time Frame: Change from baseline to Day 43 ]

21.  Secondary:   Change From Baseline to Day 43 in Each YMRS Item Score No. 11   [ Time Frame: Change from baseline to Day 43 ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


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: NCT00931723     History of Changes
Other Study ID Numbers: D144AC00003
Study First Received: June 29, 2009
Results First Received: November 17, 2011
Last Updated: March 27, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Ukraine: State Pharmacological Center - Ministry of Health