Status:
COMPLETED
SGA-induced Metabolic Syndrome in Bipolar Youth
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Bipolar Youth Treated With Second-generation Antipsychotics
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
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 fi...
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 (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01858948
Start Date
July 1 2013
End Date
April 1 2018
Last Update
November 25 2022
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45219