Status:
COMPLETED
Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
High Triglycerides
Hypercholesterolemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 hypo...
Detailed Description
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. Eligible subjects incl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00833976
Start Date
July 1 2009
End Date
March 1 2013
Last Update
July 2 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114