Trial Outcomes & Findings for NAPLS Omega-3 Fatty Acid Versus Placebo Study (NCT NCT01429454)
NCT ID: NCT01429454
Last Updated: 2021-02-25
Results Overview
The rate of conversion to psychosis among prodromal patients assigned at random to Omega-3 Fatty Acids at 12 months will be significantly lower than that among patients assigned to placebo.The Structured Interview for Prodromal Syndromes (SIPS) include the "Presence of Psychotic Syndrome (POPS)" scale that determines if the criteria for conversion to psychosis are met. The scale is binary, a 1 equals conversion and 0 equals non-conversion.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
127 participants
Primary outcome timeframe
12 months
Results posted on
2021-02-25
Participant Flow
Participant milestones
| Measure |
Soybean-Corn Blend Capsule
The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them.
Placebo: The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them. The dose will be 2 capsules per day.
|
Omega 3 Long Chain Fatty Acid
The Omega-3 Fatty Acid compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA.
Omega-3 Long Chain Fatty Acid: : The Omega-3FA compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA.
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
65
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
27
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NAPLS Omega-3 Fatty Acid Versus Placebo Study
Baseline characteristics by cohort
| Measure |
Soybean-Corn Blend Capsule
n=62 Participants
The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them.
Placebo: The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them. The dose will be 2 capsules per day.
|
Omega 3 Long Chain Fatty Acid
n=65 Participants
The Omega-3 Fatty Acid compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA.
Omega-3 Long Chain Fatty Acid: : The Omega-3FA compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
65 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
|
18.37 years
STANDARD_DEVIATION 4.66 • n=5 Participants
|
18.95 years
STANDARD_DEVIATION 4.65 • n=7 Participants
|
18.69 years
STANDARD_DEVIATION 4.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
51 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The population included participants who met the criteria for Clinical High Risk for Psychosis
The rate of conversion to psychosis among prodromal patients assigned at random to Omega-3 Fatty Acids at 12 months will be significantly lower than that among patients assigned to placebo.The Structured Interview for Prodromal Syndromes (SIPS) include the "Presence of Psychotic Syndrome (POPS)" scale that determines if the criteria for conversion to psychosis are met. The scale is binary, a 1 equals conversion and 0 equals non-conversion.
Outcome measures
| Measure |
Omega 3 Fatty Acid
n=65 Participants
Omega 3 Fatty Acid Supplementation
|
Placebo
n=62 Participants
Soybean/corn blend
|
|---|---|---|
|
Rate of Conversion to Psychosis.
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 month follow upPopulation: These subject numbers represent the number of participants who completed the 6 month evaluation and had symptom ratings performed.
The reduction from baseline in the Scale of Prodromal Symptoms (SOPS) total score (indexing severity of positive, negative, and general symptoms) at 6 and 12 months will be significantly greater in prodromal patients assigned at random to Omega-3 Fatty Acids than in patients assigned to placebo. Minimum SOPS score= 0 Maximum SOPS score= 114 Higher Total SOPS score does not necessarily mean the subject is more "psychotic" as the aggregate score is that of four independent categorically defined symptom subscales, including: Positive Symptoms Scale, Negative Symptoms Scale, Disorganized Symptoms Scale, and General Symptoms Scale. However, a higher Total SOPS score would likely indicate an individual is presenting with more overall symptoms.The Structured Interview for Prodromal Syndromes (SIPS) determines if the criteria for conversion to psychosis has been met.
Outcome measures
| Measure |
Omega 3 Fatty Acid
n=34 Participants
Omega 3 Fatty Acid Supplementation
|
Placebo
n=36 Participants
Soybean/corn blend
|
|---|---|---|
|
Scale of Prodromal Symptoms (SOPS) Total Score (Indexing Severity of Positive, Negative, and General Symptoms)
|
27.2 score on a scale
Standard Deviation 12.4
|
28.8 score on a scale
Standard Deviation 15.4
|
Adverse Events
Soybean-Corn Blend Capsule
Serious events: 4 serious events
Other events: 48 other events
Deaths: 0 deaths
Omega 3 Long Chain Fatty Acid
Serious events: 2 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Soybean-Corn Blend Capsule
n=62 participants at risk
The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them.
Placebo: The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them. The dose will be 2 capsules per day.
|
Omega 3 Long Chain Fatty Acid
n=65 participants at risk
The Omega-3 Fatty Acid compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA.
Omega-3 Long Chain Fatty Acid: : The Omega-3FA compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization due to suicidal ideation
|
1.6%
1/62 • Number of events 1 • 1 year
|
1.5%
1/65 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Hospitalization due to severe stomach pain diagnosed as Crohn's disease
|
0.00%
0/62 • 1 year
|
1.5%
1/65 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Attempted suicide
|
1.6%
1/62 • Number of events 1 • 1 year
|
0.00%
0/65 • 1 year
|
|
Psychiatric disorders
Attempt to quiet auditory hallucinations
|
1.6%
1/62 • Number of events 1 • 1 year
|
0.00%
0/65 • 1 year
|
|
Psychiatric disorders
Suicidal Ideation
|
1.6%
1/62 • Number of events 1 • 1 year
|
0.00%
0/65 • 1 year
|
Other adverse events
| Measure |
Soybean-Corn Blend Capsule
n=62 participants at risk
The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them.
Placebo: The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them. The dose will be 2 capsules per day.
|
Omega 3 Long Chain Fatty Acid
n=65 participants at risk
The Omega-3 Fatty Acid compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA.
Omega-3 Long Chain Fatty Acid: : The Omega-3FA compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA.
|
|---|---|---|
|
Nervous system disorders
Sedation/drowsiness
|
45.2%
28/62 • Number of events 28 • 1 year
|
55.4%
36/65 • Number of events 36 • 1 year
|
|
General disorders
Irritability
|
58.1%
36/62 • Number of events 36 • 1 year
|
50.8%
33/65 • Number of events 33 • 1 year
|
|
General disorders
Headache
|
51.6%
32/62 • Number of events 32 • 1 year
|
47.7%
31/65 • Number of events 31 • 1 year
|
|
General disorders
Insomnia
|
41.9%
26/62 • Number of events 26 • 1 year
|
53.8%
35/65 • Number of events 35 • 1 year
|
|
General disorders
Sleep disturbance, other
|
41.9%
26/62 • Number of events 26 • 1 year
|
53.8%
35/65 • Number of events 35 • 1 year
|
|
General disorders
Fatigue/weakness
|
43.5%
27/62 • Number of events 27 • 1 year
|
47.7%
31/65 • Number of events 31 • 1 year
|
|
General disorders
Excitement/nervousness
|
41.9%
26/62 • Number of events 26 • 1 year
|
44.6%
29/65 • Number of events 29 • 1 year
|
|
General disorders
Appetite decrease
|
40.3%
25/62 • Number of events 25 • 1 year
|
43.1%
28/65 • Number of events 28 • 1 year
|
|
General disorders
Memory problems
|
40.3%
25/62 • Number of events 25 • 1 year
|
38.5%
25/65 • Number of events 25 • 1 year
|
|
General disorders
Sensory perception abnormality
|
38.7%
24/62 • Number of events 24 • 1 year
|
40.0%
26/65 • Number of events 26 • 1 year
|
|
General disorders
Malaise
|
33.9%
21/62 • Number of events 21 • 1 year
|
38.5%
25/65 • Number of events 25 • 1 year
|
|
Gastrointestinal disorders
Stomach/abdominal discomfort
|
35.5%
22/62 • Number of events 22 • 1 year
|
36.9%
24/65 • Number of events 24 • 1 year
|
|
Psychiatric disorders
Hallucinations
|
37.1%
23/62 • Number of events 23 • 1 year
|
30.8%
20/65 • Number of events 20 • 1 year
|
|
General disorders
Nasal congestion
|
30.6%
19/62 • Number of events 19 • 1 year
|
36.9%
24/65 • Number of events 24 • 1 year
|
|
General disorders
Mentation impaired
|
30.6%
19/62 • Number of events 19 • 1 year
|
32.3%
21/65 • Number of events 21 • 1 year
|
|
General disorders
Dizziness/faintness
|
22.6%
14/62 • Number of events 14 • 1 year
|
36.9%
24/65 • Number of events 24 • 1 year
|
|
Gastrointestinal disorders
Nausea/vomiting
|
30.6%
19/62 • Number of events 19 • 1 year
|
29.2%
19/65 • Number of events 19 • 1 year
|
|
General disorders
Appetite increase
|
30.6%
19/62 • Number of events 19 • 1 year
|
29.2%
19/65 • Number of events 19 • 1 year
|
|
Gastrointestinal disorders
Weight gain
|
27.4%
17/62 • Number of events 17 • 1 year
|
32.3%
21/65 • Number of events 21 • 1 year
|
|
Ear and labyrinth disorders
Tinnitus/difficulty hearing
|
30.6%
19/62 • Number of events 19 • 1 year
|
26.2%
17/65 • Number of events 17 • 1 year
|
|
General disorders
Dry mouth
|
24.2%
15/62 • Number of events 15 • 1 year
|
32.3%
21/65 • Number of events 21 • 1 year
|
|
Gastrointestinal disorders
Weight loss
|
22.6%
14/62 • Number of events 14 • 1 year
|
30.8%
20/65 • Number of events 20 • 1 year
|
|
General disorders
Muscle twitching
|
29.0%
18/62 • Number of events 18 • 1 year
|
23.1%
15/65 • Number of events 15 • 1 year
|
|
Psychiatric disorders
Depersonalization
|
25.8%
16/62 • Number of events 16 • 1 year
|
24.6%
16/65 • Number of events 16 • 1 year
|
|
General disorders
Muscle cramps
|
22.6%
14/62 • Number of events 14 • 1 year
|
27.7%
18/65 • Number of events 18 • 1 year
|
|
Cardiac disorders
Tachycardia/palpitations
|
27.4%
17/62 • Number of events 17 • 1 year
|
23.1%
15/65 • Number of events 15 • 1 year
|
|
Psychiatric disorders
Derealization
|
24.2%
15/62 • Number of events 15 • 1 year
|
23.1%
15/65 • Number of events 15 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Ataxia/impaired coordination
|
21.0%
13/62 • Number of events 13 • 1 year
|
26.2%
17/65 • Number of events 17 • 1 year
|
|
Cardiac disorders
Chest pain
|
19.4%
12/62 • Number of events 12 • 1 year
|
26.2%
17/65 • Number of events 17 • 1 year
|
|
Psychiatric disorders
Delusions
|
21.0%
13/62 • Number of events 13 • 1 year
|
23.1%
15/65 • Number of events 15 • 1 year
|
|
General disorders
Sweating excessively
|
16.1%
10/62 • Number of events 10 • 1 year
|
26.2%
17/65 • Number of events 17 • 1 year
|
|
Eye disorders
Vision blurred
|
19.4%
12/62 • Number of events 12 • 1 year
|
21.5%
14/65 • Number of events 14 • 1 year
|
|
General disorders
Tremor
|
24.2%
15/62 • Number of events 15 • 1 year
|
16.9%
11/65 • Number of events 11 • 1 year
|
|
General disorders
Speech slurred
|
22.6%
14/62 • Number of events 14 • 1 year
|
15.4%
10/65 • Number of events 10 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
22.6%
14/62 • Number of events 14 • 1 year
|
15.4%
10/65 • Number of events 10 • 1 year
|
|
General disorders
Dermatitis/allergy
|
22.6%
14/62 • Number of events 14 • 1 year
|
15.4%
10/65 • Number of events 10 • 1 year
|
|
General disorders
Other
|
9.7%
6/62 • Number of events 6 • 1 year
|
26.2%
17/65 • Number of events 17 • 1 year
|
|
General disorders
Libido decrease
|
12.9%
8/62 • Number of events 8 • 1 year
|
16.9%
11/65 • Number of events 11 • 1 year
|
|
General disorders
Salivation increase
|
11.3%
7/62 • Number of events 7 • 1 year
|
15.4%
10/65 • Number of events 10 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
8.1%
5/62 • Number of events 5 • 1 year
|
16.9%
11/65 • Number of events 11 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Abnormal muscle tone/movement
|
9.7%
6/62 • Number of events 6 • 1 year
|
12.3%
8/65 • Number of events 8 • 1 year
|
|
General disorders
Hyperventilation
|
9.7%
6/62 • Number of events 6 • 1 year
|
12.3%
8/65 • Number of events 8 • 1 year
|
|
General disorders
Libido increase
|
9.7%
6/62 • Number of events 6 • 1 year
|
12.3%
8/65 • Number of events 8 • 1 year
|
|
General disorders
Edema
|
8.1%
5/62 • Number of events 5 • 1 year
|
6.2%
4/65 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Urination problems
|
0.00%
0/62 • 1 year
|
4.6%
3/65 • Number of events 3 • 1 year
|
|
General disorders
Fishy burp
|
9.7%
6/62 • Number of events 6 • 1 year
|
15.4%
10/65 • Number of events 10 • 1 year
|
Additional Information
Dr. Kristin Cadenhead
University of California San Diego
Phone: (619) 543-6445
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place