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Trial Outcomes & Findings for Omega-3 Fatty Acids as Adjunct Treatment for Major Depressive Disorder (NCT NCT00511810)

NCT ID: NCT00511810

Last Updated: 2016-05-27

Results Overview

Depression symptom severity was determined with the Children's Depression Rating Scale-Revised (CDRS-R), which is a brief rating scale based on a semi-structured interview with the child. It is a 17-item observer-rated questionnaire where the 17 symptom areas are rated on a 6- or 7-point scale. Total score ranges from a low (not depressed) of 17 to a maximum (very depressed) of 108. Remission was defined as a CDRS-R score of \<28. (The total score is the sum of the ratings on each of the 17 items.)

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

20 participants

Primary outcome timeframe

10 weeks

Results posted on

2016-05-27

Participant Flow

Recruitment started in August, 2007 at the University of Cincinnati, Medical Sciences Building.

A total of 24 patients were screened and 20 patients met inclusion criteria.

Participant milestones

Participant milestones
Measure
High Dose Fish Oil
Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day) High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
Low Dose Fish Oil
Capsule omega-3 fatty acids 2.4g/day (4 capsules/day) Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)
Overall Study
STARTED
8
12
Overall Study
COMPLETED
7
7
Overall Study
NOT COMPLETED
1
5

Reasons for withdrawal

Reasons for withdrawal
Measure
High Dose Fish Oil
Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day) High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
Low Dose Fish Oil
Capsule omega-3 fatty acids 2.4g/day (4 capsules/day) Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)
Overall Study
Lost to Follow-up
1
2
Overall Study
Lack of Efficacy
0
2
Overall Study
Refused second scn
0
1

Baseline Characteristics

Omega-3 Fatty Acids as Adjunct Treatment for Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
High Dose Fish Oil
n=8 Participants
Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day) High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
Low Dose Fish Oil
n=12 Participants
Capsule omega-3 fatty acids 2.4g/day (4 capsules/day) Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)
Total
n=20 Participants
Total of all reporting groups
Age, Categorical
<=18 years
8 Participants
n=5 Participants
12 Participants
n=7 Participants
20 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
13.3 years
STANDARD_DEVIATION 3.2 • n=5 Participants
16.7 years
STANDARD_DEVIATION 2.9 • n=7 Participants
15.0 years
STANDARD_DEVIATION 3.05 • n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
9 Participants
n=7 Participants
14 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants
Region of Enrollment
United States
8 participants
n=5 Participants
12 participants
n=7 Participants
20 participants
n=5 Participants
Depression Score
33.5 CDRS-R Score
STANDARD_DEVIATION 3.1 • n=5 Participants
31.9 CDRS-R Score
STANDARD_DEVIATION 6.5 • n=7 Participants
32.7 CDRS-R Score
STANDARD_DEVIATION 4.8 • n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Depression symptom severity was determined with the Children's Depression Rating Scale-Revised (CDRS-R), which is a brief rating scale based on a semi-structured interview with the child. It is a 17-item observer-rated questionnaire where the 17 symptom areas are rated on a 6- or 7-point scale. Total score ranges from a low (not depressed) of 17 to a maximum (very depressed) of 108. Remission was defined as a CDRS-R score of \<28. (The total score is the sum of the ratings on each of the 17 items.)

Outcome measures

Outcome measures
Measure
Baseline CDRS-R: High Dose Fish Oil
n=8 Participants
CDRS-R scores were computed for High Fish Oil groups.
Baseline CDRS-R: Low Dose Fish Oil
n=12 Participants
CDRS-R scores were computed for Low Fish Oil groups.
Mood Symptoms Ratings
33.0 CDRS-R score
Standard Deviation 1.5
33.1 CDRS-R score
Standard Deviation 1.7

Adverse Events

High Dose Fish Oil

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

Low Dose Fish Oil

Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
High Dose Fish Oil
n=8 participants at risk
Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day) High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
Low Dose Fish Oil
n=12 participants at risk
Capsule omega-3 fatty acids 2.4g/day (4 capsules/day) Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)
Psychiatric disorders
Worsening of depressive symptoms
0.00%
0/8
16.7%
2/12 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Robert McNamara, PhD

University of Cincinnati

Phone: 513-558-5601

Results disclosure agreements

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