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



Status:Completed
Conditions:High Cholesterol, Schizophrenia, Schizophrenia, Psychiatric, Psychiatric, Metabolic, Bipolar Disorder
Therapuetic Areas:Cardiology / Vascular Diseases, Pharmacology / Toxicology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:July 2009
End Date:March 2013

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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.

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.

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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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mi
from
Boston, MA
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