A Phase 3 interventional study of Omega and Placebo in Bipolar Youth Treated With Second-generation Antipsychotics, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-11-25.
Sponsored by University of Cincinnati · Phase 3, Interventional, and Treatment
The investigators tested the hypothesis that long-chain omega-3 (LCn-3) fatty acid supplementation will attenuate the adverse cardiometabolic effects of second-generation antipsychotics exposure in first-episode adolescent manic patients.
Following acute (6-week) open-label treatment with quetiapine, first-episode adolescent manic patients (ages 10-17 years) were randomized to double-blind adjunctive treatment with long-chain omega-3 (LCn-3) fatty acids or placebo for 24 weeks to investigate protective effects on the of adverse cardiometabolic events and weight gain during quetiapine maintenance therapy. They will have 6 visits over a 24-week period.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 19 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.
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Exclusion Criteria:
Patients will be randomized to EPA+DHA supplements (OmegaRx) at fixed dose of 3.0 g/day (EPA: 2.0 g, DHA: 1.0 g; 5 capsules/d) for 24 weeks.
Drug: Omega · Drug: Quetiapine fumarate
Patients will be randomized to similar in shape an color placebo supplements (corn oil)
Drug: Placebo · Drug: Quetiapine fumarate
Omega-3 supplements
Also known as: EPA+DHA supplements (OmegaRx)
Similar in shape and color to Omega supplements
Also known as: Placebo supplements (corn oil) provided by the Inflammation Research Foundation
Prior to randomization to Omega/placebo, patients were started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.
Also known as: Seroquel
Body Mass Index (BMI)
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.
Time frame: 24 weeks
Fasting Blood Triglycerides Levels
Triglycerides 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.
Time frame: 24 weeks
Manic Symptom Severity
Manic 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.
Time frame: 24 weeks
| Milestone | Quitiapine Plus Omega | Quetiapine Plus Placebo |
|---|---|---|
| Started | 9 | 10 |
| Completed | 5 | 4 |
| Not completed | 4 | 6 |
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.
| kg/m^2 | Quitiapine Plus Omega | Quetiapine Plus Placebo |
|---|---|---|
| Body Mass Index (BMI) | 24.4 ± 4.7 | 26.3 ± 7.4 |
Triglycerides 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.
| mg/dL | Quitiapine Plus Omega | Quetiapine Plus Placebo |
|---|---|---|
| Fasting Blood Triglycerides Levels | 99.7 ± 24.9 | 88 ± 39.3 |
Manic 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.
| units on a scale | Quitiapine Plus Omega | Quetiapine Plus Placebo |
|---|---|---|
| Manic Symptom Severity | 4.3 ± 3.7 | 7.2 ± 5.1 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Quitiapine Plus Omega | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Quetiapine Plus Placebo | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | Quitiapine Plus Omega | Quetiapine Plus Placebo | Total |
|---|---|---|---|
| Mean | 15.4 ± 2.2 | 14.1 ± 1.8 | 14.7 ± 2.0 |
| Sex: Female, Male(Participants) | Quitiapine Plus Omega | Quetiapine Plus Placebo | Total |
|---|---|---|---|
| Female | 3 | 8 | 11 |
| Male | 6 | 2 | 8 |
| Race (NIH/OMB)(Participants) | Quitiapine Plus Omega | Quetiapine Plus Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 8 | 7 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Body Mass Index (BMI)(kg/m^2) | Quitiapine Plus Omega | Quetiapine Plus Placebo | Total |
|---|---|---|---|
| Mean | 23.1 ± 4.2 | 26.2 ± 6.1 | 24.7 ± 5.4 |
| Fasting blood triglyceride levels(mg/dL) | Quitiapine Plus Omega | Quetiapine Plus Placebo | Total |
|---|---|---|---|
| Mean | 122.3 ± 43.5 | 122.9 ± 54.9 | 122.6 ± 47.1 |
| Manic Symptom Severity(units on a scale) | Quitiapine Plus Omega | Quetiapine Plus Placebo | Total |
|---|---|---|---|
| Mean | 26.2 ± 6.6 | 21.1 ± 7.6 | 23.5 ± 7.4 |
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