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

Study Overview
=================
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 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.

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 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.

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

Conditions
-----------------
High Triglycerides, Hypercholesterolemia, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Lovaza


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: open-label Lovaza (omega-3 fatty acids)<br>4g per day (4g once a day or 2g two times a day) for 16 weeks | Drug: Lovaza<br>* 4 grams per day<br>* Other names: Omega 3 Fatty Acids;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Triglycerides From Baseline to 16 Weeks |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Cholesterol From Baseline to 16 Weeks |  | 16 weeks | 
| Tolerability of Omega-3 Fatty Acid Capsules (Lovaza) | At each of the visits, participants completed a questionnaire to determine tolerability of the omega-3 fatty acid capsules (Lovaza). | 16 weeks |