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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open-label Lovaza (omega-3 fatty acids) | Experimental | 4g per day (4g once a day or 2g two times a day) for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lovaza | Drug | 4 grams per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Triglycerides From Baseline to 16 Weeks | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Cholesterol From Baseline to 16 Weeks | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlene P Freeman, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| Label | URL |
|---|---|
| Massachusetts General Hospital's Center for Women's Mental Health | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-label Lovaza (Omega-3 Fatty Acids) | 4g per day (4g once a day or 2g two times a day) for 16 weeks Lovaza: 4 grams per day |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-label Lovaza (Omega-3 Fatty Acids) | 4g per day (4g once a day or 2g two times a day) for 16 weeks Lovaza: 4 grams per day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Triglycerides From Baseline to 16 Weeks | 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% | Posted | Mean | Standard Deviation | mg/dL | 16 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open-label Lovaza (Omega-3 Fatty Acids) | 4g per day (4g once a day or 2g two times a day) for 16 weeks Lovaza: 4 grams per day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marlene Freeman, MD | Massachusetts General Hospital | 617-643-6403 | mfreeman@partners.org |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| D006937 | Hypercholesterolemia |
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C405603 | Omacor |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| 16 weeks |
| Physician Decision |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Total Cholesterol From Baseline to 16 Weeks | 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% | Posted | Mean | Standard Deviation | mg/dL | 16 weeks |
|
|
|
| Secondary | 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). | All participants who took at least one dose of the study medication were included in the analyzable population. | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| 0 |
| 65 |
| 13 |
| 65 |
| Abnormal potassium levels | Renal and urinary disorders |
|
| Abnormal levels of sodium | Renal and urinary disorders |
|
| Dehydration | Renal and urinary disorders |
|
| Unpleasant taste | Gastrointestinal disorders |
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| Chest pain | Cardiac disorders |
|
| Compulsive eating | Psychiatric disorders |
|
| Gassy | Gastrointestinal disorders |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |