NCT00833976

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High Triglycerides
• Hypercholesterolemia
• Schizophrenia
• Schizoaffective Disorder
• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Lovaza	4 grams per day

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-02-02
• Last updated: 2017-07-02
• Results posted: 2016-04-04

Locations

1 site across 1 country: United States