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

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ClinicalTrials.gov Identifier: NCT00388973
Recruitment Status : Completed
First Posted : October 17, 2006
Results First Posted : April 1, 2010
Last Update Posted : April 1, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: Quetiapine
Enrollment 338
Recruitment Details International multi-center study, 53 sites recruited between Sept 2006 and Dec 2007
Pre-assignment Details Screening for eligibility and wash-out of restricted medications. At least moderate depression symptoms assessed by the Hamilton Rating Scale for Depression
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description Quetiapine fumarate XR - flexibly dosed (50 - 300 mg) Placebo
Period Title: Overall Study
Started 166 [1] 172 [1]
Completed Study 110 114
Completed 110 [2] 114 [2]
Not Completed 56 58
Reason Not Completed
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
Arm/Group Title Quetiapine XR Placebo Total
Hide Arm/Group Description Quetiapine fumarate XR - flexibly dosed (50 - 300 mg) Placebo Total of all reporting groups
Overall Number of Baseline Participants 166 172 338
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 166 participants 172 participants 338 participants
66 to 75 years 135 137 272
>75 years 31 35 66
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 172 participants 338 participants
Female
116
  69.9%
120
  69.8%
236
  69.8%
Male
50
  30.1%
52
  30.2%
102
  30.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 166 participants 172 participants 338 participants
Europe 124 126 250
North America 24 27 51
South America 18 19 37
DSM IV diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 166 participants 172 participants 338 participants
296.2x - Major depressive disorder, single episode 27 25 52
296.3x - Major depressive disorder, recurrent 139 147 286
1.Primary Outcome
Title Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.
Hide Description MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value.
Time Frame Baseline to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
Placebo
Overall Number of Participants Analyzed 164 171
Least Squares Mean (Standard Deviation)
Unit of Measure: units on scale
-16  (8) -9  (8)
2.Secondary Outcome
Title Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q)
Hide Description Q-LES-Q as percent of maximum (0 to 100%) calculated as Week 9 - baseline, where higher values indicate better quality of life.
Time Frame Baseline to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
Placebo
Overall Number of Participants Analyzed 164 171
Least Squares Mean (Standard Deviation)
Unit of Measure: Percentage of Improvement
17  (14) 9  (14)
3.Secondary Outcome
Title Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q)
Hide Description Item 15 the Quality of Life, Enjoyment Satisfaction Questionnaire (score 1 least -5 best) on Q-LES-Q, calculated as Week 9 value - baseline value
Time Frame Baseline to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study. Patients not on medication at baseline would have left the item blank and therefore no change from baseline could be calculated
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
Placebo
Overall Number of Participants Analyzed 55 70
Median (Full Range)
Unit of Measure: units on scale
0
(-1 to 2)
0
(-3 to 3)
4.Secondary Outcome
Title Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A)
Hide Description Change in HAM-A total score (total score 0-56), calculated as Week 9 value - baseline value, where lower scores indicate less anxiety.
Time Frame Baseline to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
Placebo
Overall Number of Participants Analyzed 164 171
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-11  (6) -5  (8)
5.Secondary Outcome
Title Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index
Hide Description The Pittsburgh Sleep Quality Index is an eighteen questionnaire scored with 7 sleep component scores each on a 0 to 3 scale, total score range from 0 to 21, worst value 21, best value 0
Time Frame Baseline to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
Placebo
Overall Number of Participants Analyzed 164 171
Least Squares Mean (Standard Deviation)
Unit of Measure: units on scale
-6  (4) -3  (4)
6.Secondary Outcome
Title Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10
Hide Description The suicide item is a single item of the Montgomery-Asberg Depression Rating Scale with a range of values from 0 to 6, worst value 6, best value 0
Time Frame Baseline to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
Placebo
Overall Number of Participants Analyzed 164 171
Median (Full Range)
Unit of Measure: units on scale
0
(-2 to 2)
0
(-2 to 5)
7.Secondary Outcome
Title Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A)
Hide Description The Somatic symptom Cluster of the Hamilton Anxiety Scale is a 7 item cluster associated with somatic symptoms *somatic muscular, somatic sensory, cardiovascular system, respiratory system, gastrointestinal system, genitourinary system, autonomic system) with a range of values from 0 to 28, worst value 28, best value 0
Time Frame Baseline to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
Placebo
Overall Number of Participants Analyzed 164 171
Median (Full Range)
Unit of Measure: units on scale
-4
(-15 to 7)
-2
(-14 to 6)
8.Secondary Outcome
Title Tolerability as Measured by Adverse Event Withdrawals During Treatment
Hide Description [Not Specified]
Time Frame Baseline to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized patients.
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
Placebo
Overall Number of Participants Analyzed 166 172
Measure Type: Number
Unit of Measure: Participants
16 7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description Quetiapine fumarate XR - flexibly dosed (50 - 300 mg) Placebo
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   4/166 (2.41%)   2/172 (1.16%) 
Musculoskeletal and connective tissue disorders     
Polymyalgia Rheumatica  1  1/166 (0.60%)  0/172 (0.00%) 
Psychiatric disorders     
Depression  1  0/166 (0.00%)  2/172 (1.16%) 
Depressive Symptom  1  1/166 (0.60%)  0/172 (0.00%) 
Suicide Attempt  1  1/166 (0.60%)  1/172 (0.58%) 
Renal and urinary disorders     
Renal Failure Acute  1  1/166 (0.60%)  0/172 (0.00%) 
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   133/166 (80.12%)   54/172 (31.40%) 
Gastrointestinal disorders     
Dry Mouth  1  34/166 (20.48%)  0/172 (0.00%) 
Nervous system disorders     
Dizziness  1  32/166 (19.28%)  26/172 (15.12%) 
Headache  1  35/166 (21.08%)  28/172 (16.28%) 
Somnolence  1  55/166 (33.13%)  0/172 (0.00%) 
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 regard 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
Layout table for Results Point of Contact information
Name/Title: Medical Science Director, Seroquel
Organization: AstraZeneca
EMail: AZTrial_Results_Posting@astrazeneca.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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
First Submitted: October 16, 2006
First Posted: October 17, 2006
Results First Submitted: December 29, 2008
Results First Posted: April 1, 2010
Last Update Posted: April 1, 2010