Trial Outcomes & Findings for Decreasing Risk of Coronary Artery Disease in Schizophrenia by Omega-3 Fatty Acid Supplementation (NCT NCT00167310)
NCT ID: NCT00167310
Last Updated: 2017-04-10
Results Overview
Biochemical measures: Plasma levels of triglycerides, small dense LDL (LDL3- and LDL4-) cholesterol, large buoyant LDL (LDL1- and LDL2-) cholesterol, and HDL2-cholesterol.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
4 months
Results posted on
2017-04-10
Participant Flow
Participant milestones
| Measure |
Omega-3 Fatty Acid
Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
|
Placebo
Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
COMPLETED
|
21
|
18
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
| Measure |
Omega-3 Fatty Acid
Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
|
Placebo
Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
|
|---|---|---|
|
Overall Study
Protocol Violation
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
Baseline Characteristics
Decreasing Risk of Coronary Artery Disease in Schizophrenia by Omega-3 Fatty Acid Supplementation
Baseline characteristics by cohort
| Measure |
Omega-3 Fatty Acid
n=28 Participants
Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
|
Placebo
n=24 Participants
Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 8 • n=99 Participants
|
54 years
STANDARD_DEVIATION 8 • n=107 Participants
|
55 years
STANDARD_DEVIATION 8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
24 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Body Mass Index
|
31 kg/m^2
STANDARD_DEVIATION 7 • n=99 Participants
|
31 kg/m^2
STANDARD_DEVIATION 6 • n=107 Participants
|
31 kg/m^2
STANDARD_DEVIATION 6 • n=206 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Plasma triglyceride levels
Biochemical measures: Plasma levels of triglycerides, small dense LDL (LDL3- and LDL4-) cholesterol, large buoyant LDL (LDL1- and LDL2-) cholesterol, and HDL2-cholesterol.
Outcome measures
| Measure |
Omega-3 Fatty Acid
n=21 Participants
Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
|
Placebo
n=18 Participants
Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
|
|---|---|---|
|
Plasma Levels of Triglycerides and Lipoprotein Cholesterol
Plasma triglyceride
|
155 mg/dL
Standard Deviation 78
|
182 mg/dL
Standard Deviation 67
|
|
Plasma Levels of Triglycerides and Lipoprotein Cholesterol
Plasma LDL-1 cholesterol
|
12.68 mg/dL
Standard Deviation 4.93
|
16.92 mg/dL
Standard Deviation 7.10
|
|
Plasma Levels of Triglycerides and Lipoprotein Cholesterol
Plasma LDL-2 cholesterol
|
14.62 mg/dL
Standard Deviation 11.36
|
15.79 mg/dL
Standard Deviation 12.37
|
|
Plasma Levels of Triglycerides and Lipoprotein Cholesterol
Plasma LDL-3 cholesterol
|
40.93 mg/dL
Standard Deviation 14.69
|
43.47 mg/dL
Standard Deviation 23.44
|
|
Plasma Levels of Triglycerides and Lipoprotein Cholesterol
Plasma LDL-4 cholesterol
|
15.61 mg/dL
Standard Deviation 10.47
|
17.66 mg/dL
Standard Deviation 12.50
|
|
Plasma Levels of Triglycerides and Lipoprotein Cholesterol
Plasma HDL-2 cholesterol
|
8.00 mg/dL
Standard Deviation 3.96
|
8.56 mg/dL
Standard Deviation 2.41
|
SECONDARY outcome
Timeframe: 4 monthsBiochemical Measures: Plasma levels of total cholesterol, LDL-cholesterol, HDL-cholesterol, VLDL-cholesterol, Lp(a) cholesterol, IDL-cholesterol, HDL3-cholesterol, VLDL1,2-cholesterol, and VLDL3-cholesterol.
Outcome measures
| Measure |
Omega-3 Fatty Acid
n=21 Participants
Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
|
Placebo
n=18 Participants
Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
|
|---|---|---|
|
Plasma Cholesterol Levels in Various Lipoprotein Fractions
Plasma total cholesterol
|
158 mg/dL
Standard Deviation 38
|
175 mg/dL
Standard Deviation 45
|
|
Plasma Cholesterol Levels in Various Lipoprotein Fractions
Plasma LDL cholesterol
|
98.14 mg/dL
Standard Deviation 30.50
|
109.83 mg/dL
Standard Deviation 37.55
|
|
Plasma Cholesterol Levels in Various Lipoprotein Fractions
Plasma HDL cholesterol
|
38.95 mg/dL
Standard Deviation 11.79
|
40.22 mg/dL
Standard Deviation 8.61
|
|
Plasma Cholesterol Levels in Various Lipoprotein Fractions
Plasma VLDL cholesterol
|
21.24 mg/dL
Standard Deviation 5.27
|
24.67 mg/dL
Standard Deviation 6.06
|
|
Plasma Cholesterol Levels in Various Lipoprotein Fractions
Plasma Lp(a) cholesterol
|
6.10 mg/dL
Standard Deviation 4.06
|
4.83 mg/dL
Standard Deviation 2.71
|
|
Plasma Cholesterol Levels in Various Lipoprotein Fractions
Plasma IDL cholesterol
|
8.24 mg/dL
Standard Deviation 5.70
|
11.17 mg/dL
Standard Deviation 6.14
|
|
Plasma Cholesterol Levels in Various Lipoprotein Fractions
Plasma HDL3 cholesterol
|
31.00 mg/dL
Standard Deviation 8.26
|
31.61 mg/dL
Standard Deviation 7.28
|
|
Plasma Cholesterol Levels in Various Lipoprotein Fractions
Plasma VLDL1 + VLDL2 cholesterol
|
9.62 mg/dL
Standard Deviation 2.85
|
11.45 mg/dL
Standard Deviation 3.26
|
|
Plasma Cholesterol Levels in Various Lipoprotein Fractions
Plasma VLDL3 cholesterol
|
11.67 mg/dL
Standard Deviation 2.82
|
13.39 mg/dL
Standard Deviation 3.09
|
Adverse Events
Omega-3 Fatty Acid
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omega-3 Fatty Acid
n=28 participants at risk
Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
|
Placebo
n=24 participants at risk
Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
|
|---|---|---|
|
Cardiac disorders
EKG report indicated sinus bradycardia with HR of 39. Patient asymptomatic.
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/24 • 4 months
|
|
Psychiatric disorders
Patient experiences mental problem
|
3.6%
1/28 • Number of events 1 • 4 months
|
4.2%
1/24 • Number of events 1 • 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place