SGA-induced Metabolic Syndrome in Bipolar Youth

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators will test the hypothesis that the adverse effects of second-generation antipsychotics exposure and the beneficial effects of long-chain omega-3 (LCn-3) fatty acids are mediated by opposing effects on the enzyme implicated in the metabolic syndrome and obesity.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Quetiapine Fumarate

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