Trial Outcomes & Findings for Quetiapine Extended Release (XR) in Bipolar Patients With Comorbid Generalized Anxiety Disorder (GAD) (NCT NCT00671853)
NCT ID: NCT00671853
Last Updated: 2016-12-29
Results Overview
A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.
COMPLETED
PHASE3
120 participants
Week 0 - Week 8
2016-12-29
Participant Flow
The study consent 120 subjects. However, 29 subjects were considered screening failures and were not randomized.
Participant milestones
| Measure |
Quetiapine XR
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
Placebo for Quetiapine XR
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
45
|
|
Overall Study
COMPLETED
|
26
|
18
|
|
Overall Study
NOT COMPLETED
|
20
|
27
|
Reasons for withdrawal
| Measure |
Quetiapine XR
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
Placebo for Quetiapine XR
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
7
|
|
Overall Study
Adverse Event
|
7
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
Lost to Follow-up
|
8
|
8
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Non-adherence with study procedures
|
1
|
4
|
Baseline Characteristics
Quetiapine Extended Release (XR) in Bipolar Patients With Comorbid Generalized Anxiety Disorder (GAD)
Baseline characteristics by cohort
| Measure |
Quetiapine XR
n=46 Participants
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
Placebo for Quetiapine XR
n=45 Participants
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 12 • n=5 Participants
|
37.4 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
37.7 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Gender
Female
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Gender
Male
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
45 participants
n=7 Participants
|
91 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 - Week 8A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.
Outcome measures
| Measure |
Quetiapine XR
n=46 Participants
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
Placebo for Quetiapine XR
n=45 Participants
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
|---|---|---|
|
Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score
|
-9.91 units on a scale
Standard Deviation 16.45
|
-7.41 units on a scale
Standard Deviation 8.13
|
SECONDARY outcome
Timeframe: Week 0 - Week 8A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.
Outcome measures
| Measure |
Quetiapine XR
n=46 Participants
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
Placebo for Quetiapine XR
n=45 Participants
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
|---|---|---|
|
Response Rate (≥ 50% Improvement) on Hamilton Rating Scale for Depression (HAM-D-17)
|
12 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Week 0 - Week 8A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression. Remission is defined by the number of participants with Hamilton Rating Scale for Depression score equal to or less than 7.
Outcome measures
| Measure |
Quetiapine XR
n=46 Participants
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
Placebo for Quetiapine XR
n=45 Participants
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
|---|---|---|
|
Remission Rate (≤ 7) on Hamilton Rating Scale for Depression (HAM-D-17)
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 0 - Week 8The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Outcome measures
| Measure |
Quetiapine XR
n=46 Participants
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
Placebo for Quetiapine XR
n=45 Participants
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
|---|---|---|
|
Change in Clinical Global Impressions of Improvement or Severity (CGI-I or S) Score
|
-1.10 units on a scale
Standard Deviation 1.16
|
-0.8 units on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Week 0 - Week 8This assessment degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70 with a higher score indicating less enjoyment and satisfaction.
Outcome measures
| Measure |
Quetiapine XR
n=46 Participants
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
Placebo for Quetiapine XR
n=45 Participants
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
|---|---|---|
|
Change in the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score
|
0.11 units on a scale
Standard Deviation 0.22
|
-0.06 units on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Week 0 - Week 8The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe
Outcome measures
| Measure |
Quetiapine XR
n=46 Participants
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
Placebo for Quetiapine XR
n=45 Participants
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
|---|---|---|
|
Change in Hamilton Rating Scale for Anxiety (HAM-A)
|
-9.54 units on a scale
Standard Deviation 7.58
|
-8.25 units on a scale
Standard Deviation 8.70
|
Adverse Events
Quetiapine XR
Placebo for Quetiapine XR
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quetiapine XR
n=46 participants at risk
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
Placebo for Quetiapine XR
n=45 participants at risk
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
|
|---|---|---|
|
Ear and labyrinth disorders
Dry Mouth
|
58.7%
27/46 • Number of events 27
|
20.0%
9/45 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/46 • Number of events 1
|
6.7%
3/45 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
6.5%
3/46 • Number of events 3
|
4.4%
2/45 • Number of events 2
|
|
Gastrointestinal disorders
Stomach Upset
|
6.5%
3/46 • Number of events 3
|
11.1%
5/45 • Number of events 5
|
|
General disorders
Dizziness
|
17.4%
8/46 • Number of events 8
|
17.8%
8/45 • Number of events 8
|
|
General disorders
Headache
|
15.2%
7/46 • Number of events 7
|
6.7%
3/45 • Number of events 3
|
|
General disorders
Increased Appetite
|
2.2%
1/46 • Number of events 1
|
8.9%
4/45 • Number of events 4
|
|
Psychiatric disorders
Sedation
|
8.7%
4/46 • Number of events 4
|
31.1%
14/45 • Number of events 14
|
Additional Information
Dr. Kemp Gao
University Hospitals Cleveland Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place