Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00388973
First received: October 16, 2006
Last updated: March 22, 2010
Last verified: March 2010
Results First Received: December 29, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Intervention: Drug: Quetiapine

  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
International multi-center study, 53 sites recruited between Sept 2006 and Dec 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening for eligibility and wash-out of restricted medications. At least moderate depression symptoms assessed by the Hamilton Rating Scale for Depression

Reporting Groups
  Description
Quetiapine XR Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
Placebo Placebo

Participant Flow:   Overall Study
    Quetiapine XR     Placebo  
STARTED     166 [1]   172 [1]
Completed Study     110     114  
COMPLETED     110 [2]   114 [2]
NOT COMPLETED     56     58  
Adverse Event                 16                 6  
Lack of Efficacy                 1                 12  
Protocol Violation                 3                 0  
Withdrawal by Subject                 14                 17  
Study specific Discontinuation Criteria                 0                 1  
Did not complete 61 days of treatment                 5                 4  
Left region                 0                 1  
Did not complete 2-week follow-up visit                 17                 17  
[1] Randomized
[2] Completed 9-week treatment and 2 week follow-up



  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
Quetiapine XR Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    Quetiapine XR     Placebo     Total  
Number of Participants  
[units: participants]
  166     172     338  
Age, Customized  
[units: Participants]
     
66 to 75 years     135     137     272  
>75 years     31     35     66  
Gender  
[units: Participants]
     
Female     116     120     236  
Male     50     52     102  
Region of Enrollment  
[units: Participants]
     
Europe     124     126     250  
North America     24     27     51  
South America     18     19     37  
DSM IV diagnosis  
[units: Participants]
     
296.2x - Major depressive disorder, single episode     27     25     52  
296.3x - Major depressive disorder, recurrent     139     147     286  



  Outcome Measures
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1.  Primary:   Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.   [ Time Frame: Baseline to Week 9 ]

2.  Secondary:   Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q)   [ Time Frame: Baseline to Week 9 ]

3.  Secondary:   Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q)   [ Time Frame: Baseline to Week 9 ]

4.  Secondary:   Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A)   [ Time Frame: Baseline to Week 9 ]

5.  Secondary:   Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index   [ Time Frame: Baseline to Week 9 ]

6.  Secondary:   Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10   [ Time Frame: Baseline to Week 9 ]

7.  Secondary:   Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A)   [ Time Frame: Baseline to Week 9 ]

8.  Secondary:   Tolerability as Measured by Adverse Event Withdrawals During Treatment   [ Time Frame: Baseline to Week 9 ]


  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: Medical Science Director, Seroquel
Organization: AstraZeneca
e-mail: AZTrial_Results_Posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: Martin Brecher, Seroquel Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00388973     History of Changes
Other Study ID Numbers: D1448C00014, EUDRACT No: 2006-001196-38
Study First Received: October 16, 2006
Results First Received: December 29, 2008
Last Updated: March 22, 2010
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Finland: Finnish Medicines Agency
Estonia: The State Agency of Medicine
Lithuania: State Medicine Control Agency - Ministry of Health
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health