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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00833976
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 65
• Location: 1
• Arm: 1
• Duration (Months): 44
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
High Triglycerides; Hypercholesterolemia; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder	Drug: Lovaza	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Omega 3 Fatty Acids

Outcome Measures

Primary Outcome Measures

1. Change in Triglycerides From Baseline to 16 Weeks [16 weeks]

Secondary Outcome Measures

1. Change in Total Cholesterol From Baseline to 16 Weeks [16 weeks]

2. Tolerability of Omega-3 Fatty Acid Capsules (Lovaza) [16 weeks]

   At each of the visits, participants completed a questionnaire to determine tolerability of the omega-3 fatty acid capsules (Lovaza).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Massachusetts General Hospital's Center for Women's Mental Health

Publications

None 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
• Other Study ID Numbers: 2008-P-002219
• First Posted: Feb 2, 2009
• Last Update Posted: Jul 2, 2017
• Last Verified: Jun 1, 2017

• Additional relevant MeSH terms: Hypercholesterolemia; Hypertriglyceridemia; Disease; Schizophrenia; Bipolar Disorder; Psychotic Disorders

Study Results

Participant Flow

Arm/Group Title	Open-label Lovaza (Omega-3 Fatty Acids)
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

Baseline Characteristics

Arm/Group Title	Open-label Lovaza (Omega-3 Fatty Acids)
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 Participants	65
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	48 (13)
Sex: Female, Male (Count of Participants)
Female	36 55.4%
Male	29 44.6%
Region of Enrollment (participants) [Number]
United States	65 100%

Outcome Measures

1. Primary Outcome

Title	Change in Triglycerides From Baseline to 16 Weeks
Time Frame	16 weeks

Outcome Measure Data

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)
Arm/Group Description	4g per day (4g once a day or 2g two times a day) for 16 weeks Lovaza: 4 grams per day
Measure Participants	16
Mean (Standard Deviation) [mg/dL]	-54.13 (83.44)

2. Secondary Outcome

Title	Change in Total Cholesterol From Baseline to 16 Weeks
Time Frame	16 weeks

Outcome Measure Data

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)
Arm/Group Description	4g per day (4g once a day or 2g two times a day) for 16 weeks Lovaza: 4 grams per day
Measure Participants	16
Mean (Standard Deviation) [mg/dL]	-1.75 (29.40)

3. Secondary Outcome

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

Outcome Measure Data

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)
Arm/Group Description	4g per day (4g once a day or 2g two times a day) for 16 weeks Lovaza: 4 grams per day
Measure Participants	23
non-tolerable	1 1.5%
tolerable	22 33.8%

Adverse Events

Arm/Group Title	Open-label Lovaza (Omega-3 Fatty Acids)
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Open-label Lovaza (Omega-3 Fatty Acids)
	Affected / at Risk (%)	# Events
Total	0/65 (0%)
Other (Not Including Serious) Adverse Events
	Open-label Lovaza (Omega-3 Fatty Acids)
	Affected / at Risk (%)	# Events
Total	13/65 (20%)
Cardiac disorders
Chest pain	1/65 (1.5%)	1
Gastrointestinal disorders
Nausea	4/65 (6.2%)	5
Unpleasant taste	2/65 (3.1%)	2
Gassy	1/65 (1.5%)	1
Psychiatric disorders
Compulsive eating	1/65 (1.5%)	1
Renal and urinary disorders
Abnormal potassium levels	2/65 (3.1%)	2
Abnormal levels of sodium	1/65 (1.5%)	1
Dehydration	1/65 (1.5%)	1

Limitations/Caveats

[Not Specified]

More Information

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.