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

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: High Triglycerides; Schizophrenia; Bipolar Disorder; Hypercholesterolemia; Schizoaffective Disorder

Treatments: Drug: Lovaza

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00833976

2008-P-002219

Details and patient eligibility

About

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.

Full 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 include men and women, ages 18-75, who have been taking an atypical antipsychotic for at least three months prior to enrollment. Atypical antipsychotics include: clozapine (Clozaril), olanzapine (Zyprexa), risperidone (Risperdal), aripiprazole (Abilify), ziprasidone (Geodon), quetiapine (Seroquel), paliperidone (Invega), asenapine (Saphris), iloperidone (Fanapt), and lurasidone (Latuda). Eligible subjects must also have serum triglycerides >200 mg/dl or high cholesterol >250 mg/dl at baseline.

Enrollment: 65 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

open-label Lovaza (omega-3 fatty acids)

Experimental group

Description:

4g per day (4g once a day or 2g two times a day) for 16 weeks

Treatment:

Drug: Lovaza