Back to resultsSGA-induced Metabolic Syndrome in Bipolar Youth
Primary Purpose
Bipolar Youth Treated With Second-generation Antipsychotics
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Omega
Placebo
Quetiapine fumarate
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Youth Treated With Second-generation Antipsychotics focused on measuring Bipolar disorder, Second-generation antipsychotics, Obesity, Cardiometabolic risk
Eligibility Criteria
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
Sites / Locations
- University of Cincinnati
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Quetiapine plus Omega
Quetiapine plus Placebo
Arm Description
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.
Patients will be randomized to similar in shape an color placebo supplements (corn oil)
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01858948
First Posted
May 16, 2013
Last Updated
November 2, 2022
Sponsor
University of Cincinnati
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT01858948
Brief Title
SGA-induced Metabolic Syndrome in Bipolar Youth
Official Title
Risk and Protective Factors for SGA-induced Metabolic Syndrome in Bipolar Youth
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Youth Treated With Second-generation Antipsychotics
Keywords
Bipolar disorder, Second-generation antipsychotics, Obesity, Cardiometabolic risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quetiapine plus Omega
Arm Type
Experimental
Arm Description
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.
Arm Title
Quetiapine plus Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will be randomized to similar in shape an color placebo supplements (corn oil)
Intervention Type
Drug
Intervention Name(s)
Omega
Other Intervention Name(s)
EPA+DHA supplements (OmegaRx)
Intervention Description
Omega-3 supplements
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo supplements (corn oil) provided by the Inflammation Research Foundation
Intervention Description
Similar in shape and color to Omega supplements
Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate
Other Intervention Name(s)
Seroquel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
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
Title
Fasting Blood Triglycerides Levels
Description
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
Secondary Outcome Measure Information:
Title
Manic Symptom Severity
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert K McNamara, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
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SGA-induced Metabolic Syndrome in Bipolar Youth
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