Trial Outcomes & Findings for Omega-3 Dietary Supplements in Schizophrenia (NCT NCT01786239)
NCT ID: NCT01786239
Last Updated: 2017-02-01
Results Overview
The primary outcome measure will be the total Brief Psychiatric Rating Scale Score. The range of the BPRS is 0 to 126 with higher scores indicated more psychological symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
16 weeks
Results posted on
2017-02-01
Participant Flow
Participant milestones
| Measure |
Omega-3 Capsules & Risperidone
Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion.
|
Amber50/50 Soybean Corn Placebo & Risperidone
Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Amber 50/50 Soybean/Corn Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Omega-3 Dietary Supplements in Schizophrenia
Baseline characteristics by cohort
| Measure |
Omega-3 Capsules & Risperidone
n=25 Participants
Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion.
|
Placebo & Risperidone
n=25 Participants
Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=93 Participants
|
25 participants
n=4 Participants
|
50 participants
n=27 Participants
|
|
Structured Clinical interview for DMS-IV (SCID)
Schizophreriform
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Structured Clinical interview for DMS-IV (SCID)
Schizophrenia
|
17 participants
n=93 Participants
|
17 participants
n=4 Participants
|
34 participants
n=27 Participants
|
|
Structured Clinical interview for DMS-IV (SCID)
Bipolar 1 Disorder
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Structured Clinical interview for DMS-IV (SCID)
Psychosis NOS
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Structured Clinical interview for DMS-IV (SCID)
Schizoaffective Disorder
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 16 weeksThe primary outcome measure will be the total Brief Psychiatric Rating Scale Score. The range of the BPRS is 0 to 126 with higher scores indicated more psychological symptoms.
Outcome measures
| Measure |
Omega-3 Capsules & Risperidone
n=25 Participants
Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion.
|
Placebo & Risperidone
n=25 Participants
Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.
Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion.
|
|---|---|---|
|
Treatment Response
Baseline BPRS Score
|
41.64 units on a scale
Standard Error 1.44
|
42.38 units on a scale
Standard Error 1.56
|
|
Treatment Response
Week 16 BPRS Score
|
22.5868 units on a scale
Standard Error 2.1744
|
27.2235 units on a scale
Standard Error 2.4397
|
Adverse Events
Omega-3 Capsules & Risperidone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo & Risperidone
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place