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

Primary Purpose

High Triglycerides, Hypercholesterolemia, Schizophrenia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lovaza
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Triglycerides

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

open-label Lovaza (omega-3 fatty acids)

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Triglycerides From Baseline to 16 Weeks

Secondary Outcome Measures

Change in Total Cholesterol From Baseline to 16 Weeks
Tolerability of Omega-3 Fatty Acid Capsules (Lovaza)
At each of the visits, participants completed a questionnaire to determine tolerability of the omega-3 fatty acid capsules (Lovaza).

Full Information

First Posted
January 29, 2009
Last Updated
June 5, 2017
Sponsor
Massachusetts General Hospital
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00833976
Brief Title
Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
Official Title
Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Triglycerides, Hypercholesterolemia, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
open-label Lovaza (omega-3 fatty acids)
Arm Type
Experimental
Arm Description
4g per day (4g once a day or 2g two times a day) for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Lovaza
Other Intervention Name(s)
Omega 3 Fatty Acids
Intervention Description
4 grams per day
Primary Outcome Measure Information:
Title
Change in Triglycerides From Baseline to 16 Weeks
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change in Total Cholesterol From Baseline to 16 Weeks
Time Frame
16 weeks
Title
Tolerability of Omega-3 Fatty Acid Capsules (Lovaza)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlene P Freeman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.womensmentalhealth.org
Description
Massachusetts General Hospital's Center for Women's Mental Health

Learn more about this trial

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

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