Bipolar Youth Treated With Second-generation Antipsychotics Clinical Trial
Official title:
Risk and Protective Factors for SGA-induced Metabolic Syndrome in Bipolar Youth
| Verified date | November 2022 |
| Source | University of Cincinnati |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 19 |
| Est. completion date | April 2018 |
| Est. primary completion date | April 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 10 Years to 17 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Cincinnati | Cincinnati | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| University of Cincinnati | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
24 weeks | |
| Primary | 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. | 24 weeks | |
| Secondary | 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. | 24 weeks |