Trial Outcomes & Findings for Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis (NCT NCT00122954)

Last Updated: 2017-06-08

Results Overview

Higher MADRS scores indicate more severe depression, and the overall score ranges from 0-60. A score of 0-6 indicates symptoms absent, 7-19 indicates mild depression, 20-34 moderate, and \> 34 severe. Our primary outcome was 50% or greater improvement on the Montgomery-Asberg Depression Rating Scale (MADRS).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

39 participants

Primary outcome timeframe

baseline to 3 months

Results posted on

2017-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.	Omega-3 Fatty Acids Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
Overall Study STARTED	18	21
Overall Study COMPLETED	16	18
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.	Omega-3 Fatty Acids Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
Overall Study Withdrawal by Subject	2	2
Overall Study Protocol Violation	0	1

Baseline Characteristics

Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=18 Participants Participants receiving soybean placebo with 1% fish oil at a daily dose of 6 grams.	Fish Oil Concentrate n=21 Participants Participants receiving fish oil concentrate at a daily dose of 6 grams (2.1 grams EPA and 1.5 grams DHA)	Total n=39 Participants Total of all reporting groups
Age, Continuous	51.9 years STANDARD_DEVIATION 10.0 • n=5 Participants	50.7 years STANDARD_DEVIATION 11.6 • n=7 Participants	51.3 years STANDARD_DEVIATION 1.81 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Disease duration	17.2 years STANDARD_DEVIATION 10.0 • n=5 Participants	16.6 years STANDARD_DEVIATION 9.5 • n=7 Participants	17 years STANDARD_DEVIATION 10.42 • n=5 Participants
Expanded Disability Status Scale (EDSS)	4.1 units on a scale STANDARD_DEVIATION 2.4 • n=5 Participants	3.2 units on a scale STANDARD_DEVIATION 2.1 • n=7 Participants	3.6 units on a scale STANDARD_DEVIATION 2.3 • n=5 Participants
Montgomery-Asberg Depression Rating Scale (MADRS)	19.1 participants STANDARD_DEVIATION 4.0 • n=5 Participants	18.4 participants STANDARD_DEVIATION 5.3 • n=7 Participants	18.75 participants STANDARD_DEVIATION 4.82 • n=5 Participants
Beck Depression Inventory (BDI)	19.6 units on a scale STANDARD_DEVIATION 5.7 • n=5 Participants	20.1 units on a scale STANDARD_DEVIATION 8.0 • n=7 Participants	19.97 units on a scale STANDARD_DEVIATION 7.05 • n=5 Participants
Eicosapentaenoic Acid	0.61 % total fatty acids STANDARD_DEVIATION 0.3 • n=5 Participants	0.58 % total fatty acids STANDARD_DEVIATION 0.2 • n=7 Participants	0.59 % total fatty acids STANDARD_DEVIATION 0.24 • n=5 Participants
Docosahexaenoic Acid	3.9 % total fatty acids STANDARD_DEVIATION 1.2 • n=5 Participants	4.0 % total fatty acids STANDARD_DEVIATION 1.0 • n=7 Participants	4.0 % total fatty acids STANDARD_DEVIATION 1.0 • n=5 Participants
Adequate antidepressant use	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Multiple sclerosis modifying therapy (MS DMT) use	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 3 months

Population: A total of 8 participants discontinued intervention (placebo n = 2, 1 colitis and 1 swallowing problems; treatment n = 6, 2 lost to follow-up, 1 bronchitis, 1 knee surgery, 1 went off antidepressant, 1 travel issues) and did not complete outcome measures

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.	Omega-3 Fatty Acids n=15 Participants Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
Montgomery-Asberg Depression Rating Scale (MADRS)	45.5 percentage of subjects	47.4 percentage of subjects

SECONDARY outcome

Timeframe: baseline to 3 months

Population: A total of 8 participants discontinued (placebo n = 2, 1 colitis, 1 swallowing problems; treatment n = 8, 2 lost to follow-up, 1 bronchitis, 1 knee surgery, 1 went off anti-depressant, 1 travel difficulties) and did not complete measures at end of study

SF-36 is a commonly used measure of health-related quality of life and is well validated in many disease conditions. Responses are self-administered and responses are summed into two subscores, the mental component summary (MCS) and physical component summary (PCS). The SF-36 has eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed on a 0-100 scale. Higher scores represent higher function.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.	Omega-3 Fatty Acids n=15 Participants Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
Quality of Life (SF-36) Physical (PCS)	-0.8 mean change of units on a scale Standard Error 0.8	1.6 mean change of units on a scale Standard Error 0.8
Quality of Life (SF-36) Mental (MCS)	4.2 mean change of units on a scale Standard Error 1.0	1.5 mean change of units on a scale Standard Error 1.0

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Omega-3 Fatty Acids

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=18 participants at risk Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.	Omega-3 Fatty Acids n=21 participants at risk Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
Renal and urinary disorders Urinary Tract Infection	22.2% 4/18 • Number of events 4 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.	0.00% 0/21 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.
Immune system disorders multiple sclerosis relapse	16.7% 3/18 • Number of events 3 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.	0.00% 0/21 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.
Infections and infestations cold or flu	16.7% 3/18 • Number of events 3 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.	14.3% 3/21 • Number of events 3 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.
Skin and subcutaneous tissue disorders bruising	0.00% 0/18 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.	14.3% 3/21 • Number of events 3 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.
Gastrointestinal disorders diarrhea	5.6% 1/18 • Number of events 1 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.	4.8% 1/21 • Number of events 1 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.
Gastrointestinal disorders nausea	0.00% 0/18 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.	4.8% 1/21 • Number of events 1 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.
Immune system disorders fatigue	16.7% 3/18 • Number of events 3 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.	0.00% 0/21 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.
Nervous system disorders numbness and tingling	11.1% 2/18 • Number of events 2 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.	0.00% 0/21 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.
Gastrointestinal disorders colitis	5.6% 1/18 • Number of events 1 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.	0.00% 0/21 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.
Nervous system disorders dizziness	5.6% 1/18 • Number of events 1 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.	4.8% 1/21 • Number of events 1 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.
Cardiac disorders arrhythmia	0.00% 0/18 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.	4.8% 1/21 • Number of events 1 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.
Reproductive system and breast disorders prolonged menstruation	0.00% 0/18 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.	4.8% 1/21 • Number of events 1 • Adverse event data were collected from baseline to end of study at 3 months Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (\>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.

Additional Information

Lynne Shinto, ND, MPH

Oregon Health & Science University

Phone: 503-494-5035

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place