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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions High Triglycerides
Hypercholesterolemia
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Intervention Drug: Lovaza
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-label Lovaza (Omega-3 Fatty Acids)
Hide Arm/Group Description

4g per day (4g once a day or 2g two times a day) for 16 weeks

Lovaza: 4 grams per day

Period Title: Overall Study
Started 65
Completed 14
Not Completed 51
Reason Not Completed
Withdrawal by Subject             5
Lost to Follow-up             4
Did not meet eligibility criteria             41
Physician Decision             1
Arm/Group Title Open-label Lovaza (Omega-3 Fatty Acids)
Hide Arm/Group Description

4g per day (4g once a day or 2g two times a day) for 16 weeks

Lovaza: 4 grams per day

Overall Number of Baseline Participants 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants
48  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Female
36
  55.4%
Male
29
  44.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 65 participants
65
1.Primary Outcome
Title Change in Triglycerides From Baseline to 16 Weeks
Hide Description [Not Specified]
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Although only 14 participants completed the triall, 16 were included in the analyzable population. The 2 participants who are analyzable but not completers were lost to follow-up. They were included in the analysis since they still had 2 measurements time points. These 16 participants all had adherence values, as determined by pill count, of ≥75%
Arm/Group Title Open-label Lovaza (Omega-3 Fatty Acids)
Hide Arm/Group Description:

4g per day (4g once a day or 2g two times a day) for 16 weeks

Lovaza: 4 grams per day

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: mg/dL
-54.13  (83.44)
2.Secondary Outcome
Title Change in Total Cholesterol From Baseline to 16 Weeks
Hide Description [Not Specified]
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Although only 14 participants completed the triall, 16 were included in the analyzable population. The 2 participants who are analyzable but not completers were lost to follow-up. They were included in the analysis since they still had 2 measurements time points. These 16 participants all had adherence values, as determined by pill count, of ≥75%
Arm/Group Title Open-label Lovaza (Omega-3 Fatty Acids)
Hide Arm/Group Description:

4g per day (4g once a day or 2g two times a day) for 16 weeks

Lovaza: 4 grams per day

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: mg/dL
-1.75  (29.40)
3.Secondary Outcome
Title Tolerability of Omega-3 Fatty Acid Capsules (Lovaza)
Hide Description At each of the visits, participants completed a questionnaire to determine tolerability of the omega-3 fatty acid capsules (Lovaza).
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who took at least one dose of the study medication were included in the analyzable population.
Arm/Group Title Open-label Lovaza (Omega-3 Fatty Acids)
Hide Arm/Group Description:

4g per day (4g once a day or 2g two times a day) for 16 weeks

Lovaza: 4 grams per day

Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
non-tolerable
1
   4.3%
tolerable
22
  95.7%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open-label Lovaza (Omega-3 Fatty Acids)
Hide Arm/Group Description

4g per day (4g once a day or 2g two times a day) for 16 weeks

Lovaza: 4 grams per day

All-Cause Mortality
Open-label Lovaza (Omega-3 Fatty Acids)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Open-label Lovaza (Omega-3 Fatty Acids)
Affected / at Risk (%) # Events
Total   0/65 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open-label Lovaza (Omega-3 Fatty Acids)
Affected / at Risk (%) # Events
Total   13/65 (20.00%)    
Cardiac disorders   
Chest pain  1/65 (1.54%)  1
Gastrointestinal disorders   
Nausea  4/65 (6.15%)  5
Unpleasant taste  2/65 (3.08%)  2
Gassy  1/65 (1.54%)  1
Psychiatric disorders   
Compulsive eating  1/65 (1.54%)  1
Renal and urinary disorders   
Abnormal potassium levels  2/65 (3.08%)  2
Abnormal levels of sodium  1/65 (1.54%)  1
Dehydration  1/65 (1.54%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Marlene Freeman, MD
Organization: Massachusetts General Hospital
Phone: 617-643-6403
EMail: mfreeman@partners.org
Layout table for additonal information
Responsible Party: Marlene P. Freeman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00833976    
Other Study ID Numbers: 2008-P-002219
First Submitted: January 29, 2009
First Posted: February 2, 2009
Results First Submitted: April 14, 2015
Results First Posted: April 4, 2016
Last Update Posted: July 2, 2017