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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: GlaxoSmithKline
• Treatments: Antipsychotic Agents

Criteria

Inclusion Criteria:

1. Female or male patients, 18-75 years of age.

2. Serum triglycerides >200 mg/dl or high cholesterol >250 mg/dl

3. 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

Exclusion Criteria:

1. Current use of triglyceride or cholesterol-lowering medication other than a statin

2. Current use of omega-3 fatty acid supplement

3. Intake of fish more than twice per week

4. Currently pregnant, or breastfeeding

5. Known hypersensitivity or allergy to omega-3 fatty acids (or any fish allergies)

6. Current use of anticoagulant medication, except for 1 baby aspirin/day - 81mg (coumadin, heparin, Plavix. etc).

7. Consumption of alcohol greater than two drinks per day or active substance abuse

8. Any medical condition that would make participation in the study unsafe, as determined by investigator