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

Phase 4

Completed

• Conditions: High Triglycerides; Schizophrenia; Hypercholesterolemia; Bipolar Disorder; Schizoaffective Disorder
• Interventions: Drug: Lovaza

• Registration Number: NCT00833976
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-30
• Study First Posted: 2009-02-02
• Study Start: 2009-07
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2015-04-14
• Results First Submitted QC: 2016-03-14
• Results First Posted: 2016-04-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-05
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
open-label Lovaza (omega-3 fatty acids)	Lovaza	4g per day (4g once a day or 2g two times a day) for 16 weeks

Primary Outcome Measures

Name	Time	Method
Change in Triglycerides From Baseline to 16 Weeks	16 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States