Trial Outcomes & Findings for Quetiapine Extended Release (XR) Treatment of Major Depressive Disorder With Comorbid Generalized Anxiety Disorder (NCT NCT00868374)
NCT ID: NCT00868374
Last Updated: 2016-12-29
Results Overview
The Hamilton Rating Scale for Depression (HAM-D-17) is a 17-item clinician-rated measure that queries symptoms of depression, with a possible total score ranging for 0 to 52. A total score of 0-7 indicates no depression, a total score of 8-12 indicates doubtful depression, a total score of 13-17 indicates mild depression, a total score of 18-24 indicates moderate depression and a total score of 25-52 indicates severe depression.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
23 participants
Primary outcome timeframe
Week 0 - Week 8
Results posted on
2016-12-29
Participant Flow
Participant milestones
| Measure |
Quetiapine XR
Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
|
Placebo
Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Quetiapine Extended Release (XR) Treatment of Major Depressive Disorder With Comorbid Generalized Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Quetiapine XR
n=12 Participants
Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
|
Placebo
n=11 Participants
Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
48.3 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
45.1 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Gender
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Gender
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 - Week 8The Hamilton Rating Scale for Depression (HAM-D-17) is a 17-item clinician-rated measure that queries symptoms of depression, with a possible total score ranging for 0 to 52. A total score of 0-7 indicates no depression, a total score of 8-12 indicates doubtful depression, a total score of 13-17 indicates mild depression, a total score of 18-24 indicates moderate depression and a total score of 25-52 indicates severe depression.
Outcome measures
| Measure |
Quetiapine XR
n=12 Participants
Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
|
Placebo
n=11 Participants
Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
|
|---|---|---|
|
Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17)
|
-0.5 units on a scale
Interval -22.1 to 21.1
|
3.9 units on a scale
Interval -1.5 to 9.4
|
Adverse Events
Quetiapine XR
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Quetiapine XR
n=12 participants at risk
Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
|
Placebo
n=11 participants at risk
Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
|
|---|---|---|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
Other adverse events
| Measure |
Quetiapine XR
n=12 participants at risk
Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
|
Placebo
n=11 participants at risk
Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
|
|---|---|---|
|
General disorders
Dry Mouth
|
50.0%
6/12 • Number of events 6
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Fatigue
|
41.7%
5/12 • Number of events 5
|
27.3%
3/11 • Number of events 3
|
|
General disorders
Headache
|
25.0%
3/12 • Number of events 3
|
0.00%
0/11
|
|
General disorders
Sedation
|
16.7%
2/12 • Number of events 2
|
0.00%
0/11
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Eye disorders
Blurred Vision
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
General disorders
Dizziness
|
8.3%
1/12 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
Psychiatric disorders
Irritability
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Muscle Stiffness
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
Eye Twitching
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Gas
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Increase Appetite
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12
|
18.2%
2/11 • Number of events 2
|
Additional Information
Dr. Keming Gao
University Hospitals Cleveland Medical Center
Phone: 216-844-2865
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place