Trial Outcomes & Findings for SGA-induced Metabolic Syndrome in Bipolar Youth (NCT NCT01858948)
NCT ID: NCT01858948
Last Updated: 2022-11-25
Results Overview
Body Mass Index (BMI) is a measure of body fat calculated as weight in kilograms divided by height in meters squared (kg/m\^2). BMI Categories are: Underweight = \<18.5; Normal weight = 18.5-24.9; Overweight = 25-29.9; Obesity = BMI of 30 or greater. Greater decreases in BMI are a better outcome.
COMPLETED
PHASE3
19 participants
24 weeks
2022-11-25
Participant Flow
All patients received 6-week open-label quetiapine prior to entering the trial.
Participant milestones
| Measure |
Quitiapine Plus Omega
Patients will be randomized to EPA+DHA supplements (OmegaRx) at a fixed dose of 3.0 g/day (EPA: 2.0 g, DHA: 1.0 g; 5 capsules/d) for 24 weeks
Omega: Omega-3 supplements
Quetiapine fumarate: Patients will be started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.
|
Quetiapine Plus Placebo
Patients will be randomized to similar in shape an color placebo supplements (corn oil)
Placebo: Similar in shape and color to Omega supplements
Quetiapine fumarate: Patients will be started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SGA-induced Metabolic Syndrome in Bipolar Youth
Baseline characteristics by cohort
| Measure |
Quitiapine Plus Omega
n=9 Participants
Patients will be randomized to EPA+DHA supplements (OmegaRx) a fixed dose of 3.0 g/day (EPA: 2.0 g, DHA: 1.0 g; 5 capsules/d) for 24 weeks
Omega: Omega-3 supplements
Quetiapine fumarate: Patients will be started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.
|
Quetiapine Plus Placebo
n=10 Participants
Patients will be randomized to similar in shape an color placebo supplements (corn oil)
Placebo: Similar in shape and color to Omega supplements
Quetiapine fumarate: Patients will be started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.4 years
STANDARD_DEVIATION 2.2 • n=99 Participants
|
14.1 years
STANDARD_DEVIATION 1.8 • n=107 Participants
|
14.7 years
STANDARD_DEVIATION 2.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
23.1 kg/m^2
STANDARD_DEVIATION 4.2 • n=99 Participants
|
26.2 kg/m^2
STANDARD_DEVIATION 6.1 • n=107 Participants
|
24.7 kg/m^2
STANDARD_DEVIATION 5.4 • n=206 Participants
|
|
Fasting blood triglyceride levels
|
122.3 mg/dL
STANDARD_DEVIATION 43.5 • n=99 Participants
|
122.9 mg/dL
STANDARD_DEVIATION 54.9 • n=107 Participants
|
122.6 mg/dL
STANDARD_DEVIATION 47.1 • n=206 Participants
|
|
Manic Symptom Severity
|
26.2 units on a scale
STANDARD_DEVIATION 6.6 • n=99 Participants
|
21.1 units on a scale
STANDARD_DEVIATION 7.6 • n=107 Participants
|
23.5 units on a scale
STANDARD_DEVIATION 7.4 • n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: First-episode adolescent manic patients treated with open-label quetiapine were randomized to adjunctive treatment with fish oil or placebo for 24-weeks.
Body Mass Index (BMI) is a measure of body fat calculated as weight in kilograms divided by height in meters squared (kg/m\^2). BMI Categories are: Underweight = \<18.5; Normal weight = 18.5-24.9; Overweight = 25-29.9; Obesity = BMI of 30 or greater. Greater decreases in BMI are a better outcome.
Outcome measures
| Measure |
Quitiapine Plus Omega
n=9 Participants
Patients will be randomized to EPA+DHA supplements (OmegaRx) for 24 weeks
Omega: Omega-3 supplements
Quetiapine fumarate: Patients will be started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.
|
Quetiapine Plus Placebo
n=10 Participants
Patients will be randomized to similar in shape an color placebo supplements (corn oil)
Placebo: Similar in shape and color to Omega supplements
Quetiapine fumarate: Patients will be started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.
|
|---|---|---|
|
Body Mass Index (BMI)
|
24.4 kg/m^2
Standard Deviation 4.7
|
26.3 kg/m^2
Standard Deviation 7.4
|
PRIMARY outcome
Timeframe: 24 weeksTriglycerides are the chemical form in which most fat exists in food as well as in the body. They're also present in blood plasma and, in association with cholesterol, form the plasma lipids. Levels are categorized as follows: Normal - Less than 150 milligrams per deciliter (mg/dL); Borderline high - 150 to 199 mg/dL; High - 200 to 499 mg/dL; Very high - 500 mg/dL or above. Greater reductions blood triglyceride levels are a better outcome.
Outcome measures
| Measure |
Quitiapine Plus Omega
n=9 Participants
Patients will be randomized to EPA+DHA supplements (OmegaRx) for 24 weeks
Omega: Omega-3 supplements
Quetiapine fumarate: Patients will be started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.
|
Quetiapine Plus Placebo
n=10 Participants
Patients will be randomized to similar in shape an color placebo supplements (corn oil)
Placebo: Similar in shape and color to Omega supplements
Quetiapine fumarate: Patients will be started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.
|
|---|---|---|
|
Fasting Blood Triglycerides Levels
|
99.7 mg/dL
Standard Deviation 24.9
|
88 mg/dL
Standard Deviation 39.3
|
SECONDARY outcome
Timeframe: 24 weeksManic symptom ratings will be obtained using the Young Mania Rating Scale (YMRS). The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania: Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania). Greater reductions from baseline indicates a greater improvement in manic symptoms.
Outcome measures
| Measure |
Quitiapine Plus Omega
n=9 Participants
Patients will be randomized to EPA+DHA supplements (OmegaRx) for 24 weeks
Omega: Omega-3 supplements
Quetiapine fumarate: Patients will be started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.
|
Quetiapine Plus Placebo
n=10 Participants
Patients will be randomized to similar in shape an color placebo supplements (corn oil)
Placebo: Similar in shape and color to Omega supplements
Quetiapine fumarate: Patients will be started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.
|
|---|---|---|
|
Manic Symptom Severity
|
4.3 units on a scale
Standard Deviation 3.7
|
7.2 units on a scale
Standard Deviation 5.1
|
Adverse Events
Quitiapine Plus Omega
Quetiapine Plus Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place