Trial Outcomes & Findings for Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder (NCT NCT00388973)
NCT ID: NCT00388973
Last Updated: 2010-04-01
Results Overview
MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value.
COMPLETED
PHASE3
338 participants
Baseline to Week 9
2010-04-01
Participant Flow
International multi-center study, 53 sites recruited between Sept 2006 and Dec 2007
Screening for eligibility and wash-out of restricted medications. At least moderate depression symptoms assessed by the Hamilton Rating Scale for Depression
Participant milestones
| Measure |
Quetiapine XR
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
172
|
|
Overall Study
Completed Study
|
110
|
114
|
|
Overall Study
COMPLETED
|
110
|
114
|
|
Overall Study
NOT COMPLETED
|
56
|
58
|
Reasons for withdrawal
| Measure |
Quetiapine XR
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
16
|
6
|
|
Overall Study
Lack of Efficacy
|
1
|
12
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
14
|
17
|
|
Overall Study
Study specific Discontinuation Criteria
|
0
|
1
|
|
Overall Study
Did not complete 61 days of treatment
|
5
|
4
|
|
Overall Study
Left region
|
0
|
1
|
|
Overall Study
Did not complete 2-week follow-up visit
|
17
|
17
|
Baseline Characteristics
Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Quetiapine XR
n=166 Participants
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
|
Placebo
n=172 Participants
Placebo
|
Total
n=338 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
66 to 75 years
|
135 Participants
n=93 Participants
|
137 Participants
n=4 Participants
|
272 Participants
n=27 Participants
|
|
Age, Customized
>75 years
|
31 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=93 Participants
|
120 Participants
n=4 Participants
|
236 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
102 Participants
n=27 Participants
|
|
Region of Enrollment
Europe
|
124 Participants
n=93 Participants
|
126 Participants
n=4 Participants
|
250 Participants
n=27 Participants
|
|
Region of Enrollment
North America
|
24 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Region of Enrollment
South America
|
18 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
DSM IV diagnosis
296.2x - Major depressive disorder, single episode
|
27 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
DSM IV diagnosis
296.3x - Major depressive disorder, recurrent
|
139 Participants
n=93 Participants
|
147 Participants
n=4 Participants
|
286 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 9Population: 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.
MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value.
Outcome measures
| Measure |
Quetiapine XR
n=164 Participants
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
|
Placebo
n=171 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.
|
-16 units on scale
Standard Deviation 8
|
-9 units on scale
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Baseline to Week 9Population: 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.
Q-LES-Q as percent of maximum (0 to 100%) calculated as Week 9 - baseline, where higher values indicate better quality of life.
Outcome measures
| Measure |
Quetiapine XR
n=164 Participants
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
|
Placebo
n=171 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q)
|
17 Percentage of Improvement
Standard Deviation 14
|
9 Percentage of Improvement
Standard Deviation 14
|
SECONDARY outcome
Timeframe: Baseline to Week 9Population: 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
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
Outcome measures
| Measure |
Quetiapine XR
n=55 Participants
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
|
Placebo
n=70 Participants
Placebo
|
|---|---|---|
|
Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q)
|
0 units on scale
Interval -1.0 to 2.0
|
0 units on scale
Interval -3.0 to 3.0
|
SECONDARY outcome
Timeframe: Baseline to Week 9Population: 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.
Change in HAM-A total score (total score 0-56), calculated as Week 9 value - baseline value, where lower scores indicate less anxiety.
Outcome measures
| Measure |
Quetiapine XR
n=164 Participants
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
|
Placebo
n=171 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A)
|
-11 units on a scale
Standard Deviation 6
|
-5 units on a scale
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Baseline to Week 9Population: 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.
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
Outcome measures
| Measure |
Quetiapine XR
n=164 Participants
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
|
Placebo
n=171 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index
|
-6 units on scale
Standard Deviation 4
|
-3 units on scale
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Baseline to Week 9Population: 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.
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
Outcome measures
| Measure |
Quetiapine XR
n=164 Participants
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
|
Placebo
n=171 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10
|
0 units on scale
Interval -2.0 to 2.0
|
0 units on scale
Interval -2.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline to Week 9Population: 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.
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
Outcome measures
| Measure |
Quetiapine XR
n=164 Participants
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
|
Placebo
n=171 Participants
Placebo
|
|---|---|---|
|
Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A)
|
-4 units on scale
Full Range -15.7 • Interval -15.0 to 7.0
|
-2 units on scale
Full Range -14.6 • Interval -14.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline to Week 9Population: All Randomized patients.
Outcome measures
| Measure |
Quetiapine XR
n=166 Participants
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
|
Placebo
n=172 Participants
Placebo
|
|---|---|---|
|
Tolerability as Measured by Adverse Event Withdrawals During Treatment
|
16 Participants
|
7 Participants
|
Adverse Events
Quetiapine XR
Placebo
Serious adverse events
| Measure |
Quetiapine XR
n=166 participants at risk
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
|
Placebo
n=172 participants at risk
Placebo
|
|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/166
|
1.2%
2/172
|
|
Psychiatric disorders
Depressive Symptom
|
0.60%
1/166
|
0.00%
0/172
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia Rheumatica
|
0.60%
1/166
|
0.00%
0/172
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.60%
1/166
|
0.00%
0/172
|
|
Psychiatric disorders
Suicide Attempt
|
0.60%
1/166
|
0.58%
1/172
|
Other adverse events
| Measure |
Quetiapine XR
n=166 participants at risk
Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
|
Placebo
n=172 participants at risk
Placebo
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
19.3%
32/166
|
15.1%
26/172
|
|
Gastrointestinal disorders
Dry Mouth
|
20.5%
34/166
|
0.00%
0/172
|
|
Nervous system disorders
Headache
|
21.1%
35/166
|
16.3%
28/172
|
|
Nervous system disorders
Somnolence
|
33.1%
55/166
|
0.00%
0/172
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER