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Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00857584
First received: March 5, 2009
Last updated: April 16, 2012
Last verified: March 2012
History of Changes
Results First Received: February 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Bipolar Disorder
Bipolar Depression
Interventions: Drug: Extended release quetiapine (quetiapine XR)
Drug: Sertraline
Drug: adequate mood stabilizer

  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 Extended Release Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
Setraline Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.

Participant Flow:   Overall Study
    Quetiapine Extended Release     Setraline  
STARTED     14     13  
Week 1     14     13  
Week 2     14     11  
Week 4     11     9  
Week 8     10     8  
COMPLETED     10     8  
NOT COMPLETED     4     5  
Lack of Efficacy                 1                 2  
Adverse Event                 2                 2  
Physician Decision                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Quetiapine Extended Release Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
Setraline Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
Total Total of all reporting groups

Baseline Measures
    Quetiapine Extended Release     Setraline     Total  
Number of Participants  
[units: participants]
 		  14     13     27  
Age  
[units: years]
Mean ± Standard Deviation 		  48.5  ± 12.5     43.3  ± 12.6     46.07  ± 12.6  
Gender  
[units: Participants]
 		     
Female     6     4     10  
Male     8     9     17  
Montgomery Asberg Depression Rating Scale (MADRS) total score, Continuous [1]
[units: score on a scale]
Mean ± Standard Deviation 		  29.5  ± 5.0     28.2  ± 5.8     28.9  ± 5.3  
Clinical Impression Global Scale - Bipolar total score (CGI-BP-M), Continuous [2]
[units: score on a scale]
Mean ± Standard Deviation 		  5.1  ± 0.7     5.3  ± 0.8     5.2  ± 0.8  
Hamilton Anxiety Rating Scale (HARS) total score, Continuous [3]
[units: score on a scale]
Mean ± Standard Deviation 		  22.4  ± 4.03     17.6  ± 4.46     20.04  ± 7.38  
[1] MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)
[2] CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 (higher scores indicating a greater clinical severity)
[3] HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms)



  Outcome Measures
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1.  Primary:   The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: baseline, week 2 ]
  Show Outcome Measure 1

2.  Secondary:   The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: baseline, week 1 ]
  Show Outcome Measure 2

3.  Secondary:   The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: baseline, week 4 ]
  Show Outcome Measure 3

4.  Secondary:   The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: baseline. week 8 ]
  Show Outcome Measure 4

5.  Secondary:   The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score   [ Time Frame: baseline, week 1 ]
  Show Outcome Measure 5

6.  Secondary:   The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score   [ Time Frame: baseline, week 2 ]
  Show Outcome Measure 6

7.  Secondary:   The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score   [ Time Frame: baseline, week 4 ]
  Show Outcome Measure 7

8.  Secondary:   The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score   [ Time Frame: baseline, week 8 ]
  Show Outcome Measure 8

9.  Secondary:   The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score   [ Time Frame: baseline, week 4 ]
  Show Outcome Measure 9

10.  Secondary:   The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score   [ Time Frame: baseline, week 8 ]
  Show Outcome Measure 10

11.  Secondary:   Number of Patients Response at Week 1   [ Time Frame: week 1 ]
  Show Outcome Measure 11

12.  Secondary:   Number of Patients With Response at Week 2   [ Time Frame: week 2 ]
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13.  Secondary:   Number of Patients With Response at Week 4.   [ Time Frame: week 4 ]
  Show Outcome Measure 13

14.  Secondary:   Number of Patients With Response at Week 8.   [ Time Frame: week 8 ]
  Hide Outcome Measure 14

Measure Type Secondary
Measure Title Number of Patients With Response at Week 8.
Measure Description

Number of patients responded to the treatment at week 8, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 8.

MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Time Frame week 8  
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.
Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.

Reporting Groups
  Description
Quetiapine Extended Release Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
Setraline Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.

Measured Values
    Quetiapine Extended Release     Setraline  
Number of Participants Analyzed  
[units: participants]
 		  10     8  
Number of Patients With Response at Week 8.  
[units: Participants]
 		  8     5  

No statistical analysis provided for Number of Patients With Response at Week 8.



15.  Secondary:   Number of Patients With Remission at Week 1.   [ Time Frame: week 1 ]
  Show Outcome Measure 15

16.  Secondary:   Number of Patients With Remission at Week 2.   [ Time Frame: week 2 ]
  Show Outcome Measure 16

17.  Secondary:   Number of Patients With Remission at Week 4.   [ Time Frame: week 4 ]
  Show Outcome Measure 17

18.  Secondary:   Number of Patients With Remission at Week 8.   [ Time Frame: week 8 ]
  Show Outcome Measure 18


  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 NOT 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.


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: NCT00857584     History of Changes
Other Study ID Numbers: D1443L00058
Study First Received: March 5, 2009
Results First Received: February 6, 2012
Last Updated: April 16, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica
Spain: Spanish Agency of Medicines