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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Marlene P. Freeman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00833976
First received: January 29, 2009
Last updated: March 14, 2016
Last verified: March 2016
  Purpose
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 Intervention Phase
High Triglycerides
Hypercholesterolemia
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Drug: Lovaza
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Triglycerides From Baseline to 16 Weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decrease in Total Cholesterol [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Tolerability of Lovaza [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: July 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: January 29, 2009
Results First Received: April 14, 2015
Last Updated: March 14, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Hypercholesterolemia
Hypertriglyceridemia
Psychotic Disorders
Affective Disorders, Psychotic
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Mental Disorders
Metabolic Diseases
Mood Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 04, 2016