- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00833976
Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
June 5, 2017 updated by: Marlene P. Freeman, MD, Massachusetts General Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: open-label Lovaza (omega-3 fatty acids)
4g per day (4g once a day or 2g two times a day) for 16 weeks
|
4 grams per day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Triglycerides From Baseline to 16 Weeks
Time Frame: 16 weeks
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total Cholesterol From Baseline to 16 Weeks
Time Frame: 16 weeks
|
16 weeks
|
|
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).
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (ACTUAL)
March 1, 2013
Study Completion (ACTUAL)
March 1, 2013
Study Registration Dates
First Submitted
January 29, 2009
First Submitted That Met QC Criteria
January 30, 2009
First Posted (ESTIMATE)
February 2, 2009
Study Record Updates
Last Update Posted (ACTUAL)
July 2, 2017
Last Update Submitted That Met QC Criteria
June 5, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-P-002219
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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