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Trial Outcomes & Findings for Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors (NCT NCT00116857)

NCT ID: NCT00116857

Last Updated: 2012-09-12

Results Overview

Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

122 participants

Primary outcome timeframe

Measured at Baseline and 10 weeks

Results posted on

2012-09-12

Participant Flow

Participant milestones

Participant milestones
Measure
Sertraline Plus Omega-3 Supplement
Sertraline 50mg 1 tablet by mouth everyday. Plus Omega-3 supplement capsules 2g by mouth everyday.
Sertraline/Corn Oil
Sertraline 50mg 1 tablet by mouth everyday. Plus corn oil placebo capsules 2 g by mouth everyday.
Overall Study
STARTED
62
60
Overall Study
COMPLETED
59
56
Overall Study
NOT COMPLETED
3
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sertraline Plus Omega-3 Supplement
n=62 Participants
Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
Sertraline/Corn Oil
n=60 Participants
Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
Total
n=122 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
50 Participants
n=5 Participants
48 Participants
n=7 Participants
98 Participants
n=5 Participants
Age, Categorical
>=65 years
12 Participants
n=5 Participants
12 Participants
n=7 Participants
24 Participants
n=5 Participants
Age Continuous
58.1 years
STANDARD_DEVIATION 9.4 • n=5 Participants
58.6 years
STANDARD_DEVIATION 8.5 • n=7 Participants
58.4 years
STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male
Female
22 Participants
n=5 Participants
19 Participants
n=7 Participants
41 Participants
n=5 Participants
Sex: Female, Male
Male
40 Participants
n=5 Participants
41 Participants
n=7 Participants
81 Participants
n=5 Participants
Region of Enrollment
United States
62 participants
n=5 Participants
60 participants
n=7 Participants
122 participants
n=5 Participants

PRIMARY outcome

Timeframe: Measured at Baseline and 10 weeks

Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment.

Outcome measures

Outcome measures
Measure
Sertraline Plus Omega-3 Supplement
n=62 Participants
Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
Sertraline/Corn Oil
n=60 Participants
Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
Beck Depression Inventory-II
16.1 units on a scale
Standard Deviation 10.2
14.8 units on a scale
Standard Deviation 9.7

Adverse Events

Sertraline Plus Omega-3 Supplement

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sertraline/Corn Oil

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert M. Carney, Ph.D.

Washington University School of Medicine

Phone: 314-286-1313

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place