NCT00833976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

April 4, 2016

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

3.7 years

First QC Date

January 29, 2009

Results QC Date

April 14, 2015

Last Update Submit

June 5, 2017

Conditions

High TriglyceridesHypercholesterolemiaSchizophreniaSchizoaffective DisorderBipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in Triglycerides From Baseline to 16 Weeks

    16 weeks

Secondary Outcomes (2)

  • Change in Total Cholesterol From Baseline to 16 Weeks

    16 weeks

  • Tolerability of Omega-3 Fatty Acid Capsules (Lovaza)

    16 weeks

Study Arms (1)

open-label Lovaza (omega-3 fatty acids)

EXPERIMENTAL

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

Drug: Lovaza

Interventions

LovazaDRUG

4 grams per day

Also known as: Omega 3 Fatty Acids
open-label Lovaza (omega-3 fatty acids)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

MeSH Terms

Conditions

HypertriglyceridemiaHypercholesterolemiaSchizophreniaPsychotic DisordersBipolar Disorder

Interventions

OmacorFatty Acids, Omega-3

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSchizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Results Point of Contact

Title
Dr. Marlene Freeman, MD
Organization
Massachusetts General Hospital
mfreeman@partners.org
617-643-6403

Study Officials

  • Marlene P Freeman, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Services, MGH Center for Women's Mental Health

Study Record Dates

First Submitted

January 29, 2009

First Posted

February 2, 2009

Study Start

July 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

July 2, 2017

Results First Posted

April 4, 2016

Record last verified: 2017-06

Locations

US(1)