SGA-induced Metabolic Syndrome in Bipolar Youth
Condition: Bipolar Youth Treated With Second-generation Antipsychotics
MeSH terms: Metabolic Syndrome
Intervention: Omega; Placebo; Quetiapine fumarate
Intervention description: Omega-3 supplements; Similar in shape and color to Omega supplements; 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.
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Bipolar disorder; Second-generation antipsychotics; Obesity; Cardiometabolic risk

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.
    

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