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OpenTrials
Completed

NCT Number: NCT00833976

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lovaza

Drug

4 grams per day

Other names: Omega 3 Fatty Acids

Primary outcomes

  1. Change in Triglycerides From Baseline to 16 Weeks

    Time frame: 16 weeks

Secondary outcomes

  1. Change in Total Cholesterol From Baseline to 16 Weeks

    Time frame: 16 weeks

  2. Tolerability of Omega-3 Fatty Acid Capsules (Lovaza)

    Time frame: 16 weeks

    At each of the visits, participants completed a questionnaire to determine tolerability of the omega-3 fatty acid capsules (Lovaza).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 2, 2009
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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