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

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ClinicalTrials.gov Identifier: NCT00833976
Recruitment Status : Completed
First Posted : February 2, 2009
Results First Posted : April 4, 2016
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Marlene P. Freeman, MD, 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.

Condition or disease Intervention/treatment Phase
High Triglycerides Hypercholesterolemia Schizophrenia Schizoaffective Disorder Bipolar Disorder Drug: Lovaza Phase 4

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  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
Study Start Date : July 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013


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
Drug: Lovaza
4 grams per day
Other Name: Omega 3 Fatty Acids



Primary Outcome Measures :
  1. Change in Triglycerides From Baseline to 16 Weeks [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833976


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
GlaxoSmithKline
Investigators
Principal Investigator: Marlene P Freeman, MD Massachusetts General Hospital

Additional Information:
Responsible Party: Marlene P. Freeman, MD, Director of Clinical Services, MGH Center for Women's Mental Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00833976     History of Changes
Other Study ID Numbers: 2008-P-002219
First Posted: February 2, 2009    Key Record Dates
Results First Posted: April 4, 2016
Last Update Posted: July 2, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Disease
Schizophrenia
Bipolar Disorder
Hypercholesterolemia
Psychotic Disorders
Hypertriglyceridemia
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs