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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

Tracking Information
First Submitted Date  ICMJE January 29, 2009
First Posted Date  ICMJE February 2, 2009
Results First Submitted Date  ICMJE April 14, 2015
Results First Posted Date  ICMJE April 4, 2016
Last Update Posted Date July 2, 2017
Study Start Date  ICMJE July 2009
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
Change in Triglycerides From Baseline to 16 Weeks [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2009)
decrease in triglycerides from baseline [ Time Frame: 16 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
  • Change in Total Cholesterol From Baseline to 16 Weeks [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2009)
decrease in total cholesterol and tolerability [ Time Frame: 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
Official Title  ICMJE Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • High Triglycerides
  • Hypercholesterolemia
  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Disorder
Intervention  ICMJE Drug: Lovaza
4 grams per day
Other Name: Omega 3 Fatty Acids
Study Arms  ICMJE Experimental: open-label Lovaza (omega-3 fatty acids)
4g per day (4g once a day or 2g two times a day) for 16 weeks
Intervention: Drug: Lovaza
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2016)
65
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2009)
40
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00833976
Other Study ID Numbers  ICMJE 2008-P-002219
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marlene P. Freeman, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Marlene P Freeman, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP