Trial Outcomes & Findings for Gao Bipolar Spectrum Lithium/Quetiapine Study (NCT NCT01526148)
NCT ID: NCT01526148
Last Updated: 2017-08-16
Results Overview
The time, as measured in number of days, for discontinuation due to all causes will be measured and used as the primary outcome measure
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
42 participants
Primary outcome timeframe
Week 16
Results posted on
2017-08-16
Participant Flow
Participant milestones
| Measure |
Lithium
Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels \> 0.6mEq/L.
|
Quetiapine
Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
24
|
|
Overall Study
COMPLETED
|
4
|
11
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
Reasons for withdrawal
| Measure |
Lithium
Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels \> 0.6mEq/L.
|
Quetiapine
Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
5
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Unstable Medical Condition
|
1
|
0
|
|
Overall Study
Unable to discontinue concomitant med
|
1
|
0
|
|
Overall Study
Moved out of state
|
1
|
0
|
|
Overall Study
Incarcerated
|
0
|
2
|
Baseline Characteristics
Gao Bipolar Spectrum Lithium/Quetiapine Study
Baseline characteristics by cohort
| Measure |
Lithium
n=18 Participants
Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels \> 0.6mEq/L.
|
Quetiapine
n=24 Participants
Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.26 years
STANDARD_DEVIATION 16.66 • n=93 Participants
|
35.58 years
STANDARD_DEVIATION 12.64 • n=4 Participants
|
38.98 years
STANDARD_DEVIATION 14.88 • n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Diagnosis
Bipolar I Disorder
|
10 participants
n=93 Participants
|
15 participants
n=4 Participants
|
25 participants
n=27 Participants
|
|
Diagnosis
Bipolar II Disorder
|
9 participants
n=93 Participants
|
7 participants
n=4 Participants
|
16 participants
n=27 Participants
|
|
Diagnosis
Bipolar NOS
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 16The time, as measured in number of days, for discontinuation due to all causes will be measured and used as the primary outcome measure
Outcome measures
| Measure |
Lithium
n=18 Participants
Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels \> 0.6mEq/L.
|
Quetiapine
n=24 Participants
Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
|
|---|---|---|
|
Time to Study Discontinuation
|
41 days
Interval 23.0 to 83.0
|
77 days
Interval 38.0 to 200.0
|
SECONDARY outcome
Timeframe: Screening and Week 16Change in homeostatic model assessment for insulin resistance (HOMA-IR) from screening to end of study. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone in the body. The HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. The higher the score, the higher the level of insulin resistance.
Outcome measures
| Measure |
Lithium
n=18 Participants
Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels \> 0.6mEq/L.
|
Quetiapine
n=24 Participants
Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
|
|---|---|---|
|
Lithium vs. Quetiapine Effects on General Cardiovascular Disease Risk as Measured by Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
|
-5.5 IR Score
Standard Deviation 15.9
|
0.2 IR Score
Standard Deviation 1.6
|
Adverse Events
Lithium
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Quetiapine
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lithium
n=18 participants at risk
Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels \> 0.6mEq/L.
|
Quetiapine
n=24 participants at risk
Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
|
|---|---|---|
|
General disorders
Excessive sleepiness / daytime somnolence
|
38.9%
7/18 • Number of events 7
|
50.0%
12/24 • Number of events 12
|
|
Gastrointestinal disorders
Stomach Upset
|
27.8%
5/18 • Number of events 5
|
0.00%
0/24
|
|
General disorders
Increased thirst
|
22.2%
4/18 • Number of events 4
|
16.7%
4/24 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
22.2%
4/18 • Number of events 4
|
0.00%
0/24
|
|
General disorders
Insomnia
|
16.7%
3/18 • Number of events 3
|
0.00%
0/24
|
|
Renal and urinary disorders
Increased urination
|
11.1%
2/18 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Tremor
|
11.1%
2/18 • Number of events 2
|
12.5%
3/24 • Number of events 3
|
|
General disorders
Headache
|
11.1%
2/18 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
|
General disorders
Muscle Stiffness
|
5.6%
1/18 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Cognitive Impairment
|
5.6%
1/18 • Number of events 1
|
12.5%
3/24 • Number of events 3
|
|
General disorders
Unusual discomfort to warm temperatures
|
5.6%
1/18 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Increased Appetite
|
5.6%
1/18 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Weight Gain
|
5.6%
1/18 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Dizziness/Lightheadedness
|
5.6%
1/18 • Number of events 1
|
25.0%
6/24 • Number of events 6
|
|
General disorders
Dry Mouth
|
0.00%
0/18
|
45.8%
11/24 • Number of events 11
|
|
Gastrointestinal disorders
Consitpation
|
0.00%
0/18
|
12.5%
3/24 • Number of events 3
|
|
Psychiatric disorders
Irritability
|
0.00%
0/18
|
8.3%
2/24 • Number of events 2
|
|
General disorders
Hot flashes
|
0.00%
0/18
|
8.3%
2/24 • Number of events 2
|
Additional Information
Keming Gao, MD, PhD
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