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

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ClinicalTrials.gov Identifier: NCT00389064
Recruitment Status : Completed
First Posted : October 18, 2006
Results First Posted : June 23, 2009
Last Update Posted : April 4, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Anxiety Disorders
Interventions Drug: Quetiapine XR
Drug: Placebo
Enrollment 450

Recruitment Details International multi-center study, 47 sites recruited between Sept 2006 and Apr 2008
Pre-assignment Details Screening for eligibility and wash-out of restriced medications
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description Quetiapine fumerate XR - flexibly dosed (50 - 300 mg) [Not Specified]
Period Title: Overall Study
Started 223 227
Completed 178 168
Not Completed 45 59
Reason Not Completed
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
Arm/Group Title Quetiapine XR Placebo Total
Hide Arm/Group Description Quetiapine fumerate XR - flexibly dosed (50 - 300 mg) [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 223 227 450
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 223 participants 227 participants 450 participants
66 to 75 years 197 195 392
> 75 years 26 32 58
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants 227 participants 450 participants
Female
161
  72.2%
157
  69.2%
318
  70.7%
Male
62
  27.8%
70
  30.8%
132
  29.3%
1.Primary Outcome
Title Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Hide Description HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization
Time Frame Randomization to Week 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (MITT) population.
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
[Not Specified]
Overall Number of Participants Analyzed 222 226
Least Squares Mean (Standard Deviation)
Unit of Measure: units on scale
-14.97  (7.4) -7.21  (7.8)
2.Secondary Outcome
Title Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score
Hide Description

Q-LES-Q total score is the sum of the first 14 items of Q-LES-Q, and this total score is converted to a % maximum total score by : (Q-LES-Q total score -14) /56 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction.

Change : percentage at week 9 minus percentage at randomization

Time Frame Randomization to Week 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
In reporting Q-LES-Q there was missing data even with last observation carried forward (LOCF), so the total number of patients analyzed is 428 ( 211 Quetiapine XR and 217 Placebo).
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
[Not Specified]
Overall Number of Participants Analyzed 211 217
Least Squares Mean (Standard Deviation)
Unit of Measure: Percentage of Maximum Total Score
14.82  (12.40) 4.94  (11.60)
3.Secondary Outcome
Title Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Hide Description CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best Change : score at week 9 minus score at randomization
Time Frame Randomization to Week 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (MITT) population.
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
[Not Specified]
Overall Number of Participants Analyzed 222 226
Least Squares Mean (Standard Deviation)
Unit of Measure: units on scale
-1.76  (1.10) -0.59  (1.00)
4.Secondary Outcome
Title Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score
Hide Description HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization
Time Frame Randomization to Week 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (MITT) population.
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
[Not Specified]
Overall Number of Participants Analyzed 222 226
Least Squares Mean (Standard Deviation)
Unit of Measure: units on scale
-8.88  (4.20) -3.81  (4.60)
5.Secondary Outcome
Title Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score
Hide Description HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization
Time Frame Randomization to Week 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (MITT) population.
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
[Not Specified]
Overall Number of Participants Analyzed 222 226
Least Squares Mean (Standard Deviation)
Unit of Measure: units on scale
-6.05  (4.00) -3.37  (3.90)
6.Secondary Outcome
Title Hamilton Rating Scale for Anxiety (HAM-A) Response.
Hide Description HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score.
Time Frame Week 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
[Not Specified]
Overall Number of Participants Analyzed 222 226
Measure Type: Number
Unit of Measure: Number of participants.
152 54
7.Secondary Outcome
Title Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission
Hide Description

HAM-A remission, defined as HAM-A total score less or equal to 7. An indicator of HAM-A remission is calculated as:

  • If HAM-A total score≤7, THEN indicator=1
  • If HAM-A total score >7, THEN indicator=0
Time Frame Week 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (MITT) population.
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
[Not Specified]
Overall Number of Participants Analyzed 222 226
Measure Type: Number
Unit of Measure: Number of participants.
89 29
8.Secondary Outcome
Title Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization
Time Frame Randomization to week 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (MITT) population.
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
[Not Specified]
Overall Number of Participants Analyzed 222 226
Least Squares Mean (Standard Deviation)
Unit of Measure: units on scale
-6.94  (4.70) -2.22  (4.70)
9.Secondary Outcome
Title Change in the Visual Analogue Scale (VAS) Measuring Pain
Hide Description Visual Analogue Scale (VAS) measuring pain (0-100 mm), 0 is best Change : scale at week 9 minus scale at randomization
Time Frame Randomization to week 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (MITT) population.
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
[Not Specified]
Overall Number of Participants Analyzed 222 226
Least Squares Mean (Standard Deviation)
Unit of Measure: mm
-17.95  (21.80) -6.18  (19.80)
10.Secondary Outcome
Title Safety and Well Tolerated as Measured in Adverse Event
Hide Description Number of patients have at least one adverse event
Time Frame From the start of treatment to last dose plus 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
[Not Specified]
Overall Number of Participants Analyzed 223 227
Measure Type: Number
Unit of Measure: Participants
145.00 114.00
11.Secondary Outcome
Title Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)
Hide Description Number of patients have adverse events associated with EPS
Time Frame From start of the study teatment to last dose plus 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
[Not Specified]
Overall Number of Participants Analyzed 223 227
Measure Type: Number
Unit of Measure: Patients
12.00 5.00
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description Quetiapine fumerate XR - flexibly dosed (50 - 300 mg) [Not Specified]
All-Cause Mortality
Quetiapine XR Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine XR Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/223 (0.45%)   3/227 (1.32%) 
Cardiac disorders     
Cardiomyopathy  1  0/223 (0.00%)  1/227 (0.44%) 
Hepatobiliary disorders     
Cholelithiasis  1  0/223 (0.00%)  1/227 (0.44%) 
Infections and infestations     
Bronchopneumonia  1  1/223 (0.45%)  0/227 (0.00%) 
Cellulitis  1  0/223 (0.00%)  1/227 (0.44%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine XR Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   171/223 (76.68%)   89/227 (39.21%) 
Gastrointestinal disorders     
Dry Mouth  1  37/223 (16.59%)  16/227 (7.05%) 
Nausea  1  20/223 (8.97%)  9/227 (3.96%) 
Nervous system disorders     
Dizziness  1  30/223 (13.45%)  16/227 (7.05%) 
Headache  1  26/223 (11.66%)  29/227 (12.78%) 
Somnolence  1  58/223 (26.01%)  19/227 (8.37%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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 PI agrees to collaborate in good faith with AstraZeneca with regards to the contents and formation of any publication or disclosure to be made by the PI and to pay due consideration to the comments, views and opinions offered by AstraZeneca
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00389064     History of Changes
Other Study ID Numbers: D1448C00015
EUDRACT No: 2006-001195-21
First Submitted: October 17, 2006
First Posted: October 18, 2006
Results First Submitted: April 15, 2009
Results First Posted: June 23, 2009
Last Update Posted: April 4, 2012