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

This study is currently recruiting participants.
Verified November 2012 by Massachusetts General Hospital
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: November 6, 2012
Last verified: November 2012
History of Changes
  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 and Cholesterol
 Drug: Lovaza
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • decrease in triglycerides from baseline [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • decrease in total cholesterol and tolerability [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Lovaza
4 grams per day
Other Name: Omega 3 Fatty Acids

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833976

Contacts
Contact: Molly Kwiatkowski 617-643-9284 mkwiatkowski@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Molly Kwiatkowski     617-643-9284     mkwiatkowski@partners.org    
Sponsors and Collaborators
Massachusetts General Hospital
GlaxoSmithKline
Investigators
Principal Investigator: Marlene P Freeman, MD Massachusetts General Hospital
  More Information

Additional Information:
Massachusetts General Hospital's Center for Women's Mental Health  This link exits the ClinicalTrials.gov site

No publications provided

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
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 21, 2013