Clinical trial NCT00833976: Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
Official title: Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: High Triglycerides
Hypercholesterolemia
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-02-02
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Triglycerides From Baseline to 16 Weeks
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in Total Cholesterol From Baseline to 16 Weeks
timeFrame: 16 weeks
measure: Tolerability of Omega-3 Fatty Acid Capsules (Lovaza)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Marlene P Freeman, MD
role: PRINCIPAL_INVESTIGATOR
References: