- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01858948
SGA-induced Metabolic Syndrome in Bipolar Youth
November 2, 2022 updated by: Robert McNamara, University of Cincinnati
Risk and Protective Factors for SGA-induced Metabolic Syndrome in Bipolar Youth
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Cincinnati, Ohio, United States, 45219
- University of Cincinnati
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- DSM-IV-TR criteria for bipolar disorder, type I, manic or mixed episode
- Baseline YMRS score > 20
- Ages 10-17 years
- Tanner scale stages III-V
- No prior exposure to SGA medications
- Fluent in English
- Provision of written informed consent by a legal guardian and written assent by the subject
- Manic or depressive symptoms do not result entirely from acute medical illness or acute intoxication or withdrawal from drugs or alcohol as determined by medical evaluation and rapid symptom resolution
- If female and of child bearing potential, agrees to use one of the following method of birth control: complete abstinence from sexual intercourse, barrier (diaphragm or condom), or oral/injectable contraceptive. For Phase II, additional Inclusion criteria are
- Receiving a stable therapeutic dose of quetiapine for a minimum of 1 week (i.e., patients who achieved remission (YMRS total score 7 during Phase I)
- Not requiring concomitant use of antidepressant or mood-stabilizer medications (see Section C.4.c. Concomitant Medications).
Exclusion Criteria:
- IQ < 70, as determined by The Wechsler Abbreviated Scale of Intelligence
- Positive pregnancy test (to avoid teratogenesis)
- A history of major cardiovascular or neurological illness
- Any lifetime DSM-IV-TR substance use disorder (nicotine dependence is permitted)
- A lifetime DSM-IV-TR diagnosis of any pervasive developmental disorder
- Any history of a hematological disorder in themselves or a first-degree relative will be excluded (since omega-3 fatty acids may be associated with anti-thrombotic effects). Similarly, concomitant use of medications with anticoagulant effects (e.g. aspirin) will be prohibited
- Allergy to fish/seafood; 8) Currently taking omega-3 fatty acid supplements
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Quetiapine plus Omega
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.
|
Omega-3 supplements
Other Names:
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.
Other Names:
|
Placebo Comparator: Quetiapine plus Placebo
Patients will be randomized to similar in shape an color placebo supplements (corn oil)
|
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.
Other Names:
Similar in shape and color to Omega supplements
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index (BMI)
Time Frame: 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. |
24 weeks
|
Fasting Blood Triglycerides Levels
Time Frame: 24 weeks
|
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.
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Manic Symptom Severity
Time Frame: 24 weeks
|
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.
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
April 1, 2018
Study Completion (Actual)
April 1, 2018
Study Registration Dates
First Submitted
May 16, 2013
First Submitted That Met QC Criteria
May 20, 2013
First Posted (Estimate)
May 21, 2013
Study Record Updates
Last Update Posted (Actual)
November 25, 2022
Last Update Submitted That Met QC Criteria
November 2, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK097599-01A1
- 5R01DK097599 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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