SGA-induced Metabolic Syndrome in Bipolar Youth

University of Cincinnati

Status and phase: Completed; Phase 3

Conditions: Bipolar Youth Treated With Second-generation Antipsychotics

Treatments: Drug: Placebo; Drug: Quetiapine fumarate; Drug: Omega

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01858948

5R01DK097599 (U.S. NIH Grant/Contract)

DK097599-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

19 participants in 2 patient groups, including a placebo group

Quetiapine plus Omega

Experimental group

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.

Treatment:

Drug: Omega

Drug: Quetiapine fumarate

Quetiapine plus Placebo

Placebo Comparator group

Description:

Patients will be randomized to similar in shape an color placebo supplements (corn oil)

Treatment:

Drug: Quetiapine fumarate

Drug: Placebo