Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia

Completed · Phase 4

Conditions studied: High Triglycerides, Hypercholesterolemia, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

In brief

This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second-generation) antipsychotic medication. The investigators hypotheses are that patients who receive Lovaza will experience a significant decrease in triglycerides from baseline. Secondary hypotheses include: Patients will experience a significant decrease in total cholesterol, and Lovaza will be well tolerated.

Key facts

Study ID

NCT00833976

Run by

Massachusetts General Hospital

People needed

65

Starts

2009-07-01

Expected to finish

2013-03-01

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female or male patients, 18-75 years of age.
• Serum triglycerides >200 mg/dl or high cholesterol >250 mg/dl
• Current use of an atypical (second-generation) antipsychotic medication - including clozapine (Clozaril), olanzapine (Zyprexa), risperidone (Risperdal), aripiprazole (Abilify), ziprasidone (Geodon), quetiapine (Seroquel), paliperidone (Invega) - for at least three months

You may not qualify if…

• Current use of triglyceride or cholesterol-lowering medication other than a statin
• Current use of omega-3 fatty acid supplement
• Intake of fish more than twice per week
• Currently pregnant, or breastfeeding
• Known hypersensitivity or allergy to omega-3 fatty acids (or any fish allergies)
• Current use of anticoagulant medication, except for 1 baby aspirin/day - 81mg (coumadin, heparin, Plavix. etc).
• Consumption of alcohol greater than two drinks per day or active substance abuse
• Any medical condition that would make participation in the study unsafe, as determined by investigator

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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