A Phase 4 interventional study of Lovaza in High Triglycerides, Hypercholesterolemia and Schizophrenia, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment
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.
1,238 studies on the registry are indexed under Hypercholesterolemia; 110 are open to participants now.
This study's enrollment of 65 is below the median of 100 across 992 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
4g per day (4g once a day or 2g two times a day) for 16 weeks
Drug: Lovaza
4 grams per day
Also known as: Omega 3 Fatty Acids
Change in Triglycerides From Baseline to 16 Weeks
Time frame: 16 weeks
Change in Total Cholesterol From Baseline to 16 Weeks
Time frame: 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).
Time frame: 16 weeks
| Milestone | Open-label Lovaza (Omega-3 Fatty Acids) |
|---|---|
| Started | 65 |
| Completed | 14 |
| Not completed | 51 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Did not meet eligibility criteria | 41 |
| Withdrew: Physician decision | 1 |
| mg/dL | Open-label Lovaza (Omega-3 Fatty Acids) |
|---|---|
| Change in Triglycerides From Baseline to 16 Weeks | -54.13 ± 83.44 |
| mg/dL | Open-label Lovaza (Omega-3 Fatty Acids) |
|---|---|
| Change in Total Cholesterol From Baseline to 16 Weeks | -1.75 ± 29.40 |
At each of the visits, participants completed a questionnaire to determine tolerability of the omega-3 fatty acid capsules (Lovaza).
| Participants | Open-label Lovaza (Omega-3 Fatty Acids) |
|---|---|
| non-tolerable | 1 |
| tolerable | 22 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open-label Lovaza (Omega-3 Fatty Acids) | — | 0/65 (0%) | 13/65 (20%) |
| Event | Open-label Lovaza (Omega-3 Fatty Acids) |
|---|---|
| NauseaGastrointestinal disorders | 4/65 |
| Abnormal potassium levelsRenal and urinary disorders | 2/65 |
| Unpleasant tasteGastrointestinal disorders | 2/65 |
| Abnormal levels of sodiumRenal and urinary disorders | 1/65 |
| DehydrationRenal and urinary disorders | 1/65 |
| Chest painCardiac disorders | 1/65 |
| Compulsive eatingPsychiatric disorders | 1/65 |
| GassyGastrointestinal disorders | 1/65 |
| Age, Continuous(years) | Open-label Lovaza (Omega-3 Fatty Acids) |
|---|---|
| Median | 48 ± 13 |
| Sex: Female, Male(Participants) | Open-label Lovaza (Omega-3 Fatty Acids) |
|---|---|
| Female | 36 |
| Male | 29 |
| Region of Enrollment(participants) | Open-label Lovaza (Omega-3 Fatty Acids) |
|---|---|
| United States | 65 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital