Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00389064
First received: October 17, 2006
Last updated: March 30, 2012
Last verified: March 2012
Results First Received: April 15, 2009  
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: Anxiety Disorders
Interventions: Drug: Quetiapine XR
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
International multi-center study, 47 sites recruited between Sept 2006 and Apr 2008

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 restriced medications

Reporting Groups
  Description
Quetiapine XR Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
Placebo No text entered.

Participant Flow:   Overall Study
    Quetiapine XR     Placebo  
STARTED     223     227  
COMPLETED     178     168  
NOT COMPLETED     45     59  
Adverse Event                 11                 3  
Lack of Efficacy                 3                 14  
Withdrawal by Subject                 17                 27  
Physician Decision                 2                 2  
Lost to Follow-up                 1                 2  
Protocol Violation                 2                 0  
Multiple Reasons                 9                 11  



  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 fumerate XR - flexibly dosed (50 - 300 mg)
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Quetiapine XR     Placebo     Total  
Number of Participants  
[units: participants]
  223     227     450  
Age, Customized  
[units: Participants]
     
66 to 75 years     197     195     392  
> 75 years     26     32     58  
Gender  
[units: Participants]
     
Female     161     157     318  
Male     62     70     132  



  Outcome Measures
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1.  Primary:   Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score   [ Time Frame: Randomization to Week 9 ]

2.  Secondary:   Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score   [ Time Frame: Randomization to Week 9 ]

3.  Secondary:   Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score   [ Time Frame: Randomization to Week 9 ]

4.  Secondary:   Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score   [ Time Frame: Randomization to Week 9 ]

5.  Secondary:   Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score   [ Time Frame: Randomization to Week 9 ]

6.  Secondary:   Hamilton Rating Scale for Anxiety (HAM-A) Response.   [ Time Frame: Week 9 ]

7.  Secondary:   Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission   [ Time Frame: Week 9 ]

8.  Secondary:   Change in Montgomery-Asberg Depression Rating Scale (MADRS)   [ Time Frame: Randomization to week 9 ]

9.  Secondary:   Change in the Visual Analogue Scale (VAS) Measuring Pain   [ Time Frame: Randomization to week 9 ]

10.  Secondary:   Safety and Well Tolerated as Measured in Adverse Event   [ Time Frame: From the start of treatment to last dose plus 30 days ]

11.  Secondary:   Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)   [ Time Frame: From start of the study teatment to last dose plus 30 days ]


  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 by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00389064     History of Changes
Other Study ID Numbers: D1448C00015, EUDRACT No: 2006-001195-21
Study First Received: October 17, 2006
Results First Received: April 15, 2009
Last Updated: March 30, 2012
Health Authority: Estonia: The State Agency of Medicine
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health