Trial Outcomes & Findings for Omega-3 Fatty Acids in Adolescent Depression (NCT NCT00312897)
NCT ID: NCT00312897
Last Updated: 2018-04-19
Results Overview
It is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child and parent. A score of ≥40 is indicative of depression, whereas a score ≤28 is often used to define remission (minimal or no symptoms).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
baseline and 10-weeks
Results posted on
2018-04-19
Participant Flow
Recruitment began in December 2005, with enrollment from January 2006 to June 2013
57 were consented, 6 did not meet eligibility and were not randomized. 3 participants enrolled in Omega-3 Fatty Acids arm but discontinued prior to receiving treatment and not included in analysis.
Participant milestones
| Measure |
Corn Oil
The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.
Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell.
|
Omega-3 Fatty Acids
The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.
Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks. Acids: 10 wk treatment period
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
24
|
|
Overall Study
COMPLETED
|
21
|
18
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Corn Oil
The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.
Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell.
|
Omega-3 Fatty Acids
The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.
Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks. Acids: 10 wk treatment period
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
discontinued prior to getting treatment
|
0
|
3
|
Baseline Characteristics
Omega-3 Fatty Acids in Adolescent Depression
Baseline characteristics by cohort
| Measure |
Corn Oil
n=27 Participants
The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.
Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell.
|
Omega 3 Fatty Acids
n=21 Participants
The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.
Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.34 years
STANDARD_DEVIATION 1.981 • n=5 Participants
|
15.68 years
STANDARD_DEVIATION 2.19 • n=7 Participants
|
16.05 years
STANDARD_DEVIATION 2.079 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 10-weeksPopulation: 3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results
It is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child and parent. A score of ≥40 is indicative of depression, whereas a score ≤28 is often used to define remission (minimal or no symptoms).
Outcome measures
| Measure |
Corn Oil
n=27 Participants
The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.
Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell.
|
Omega-3 Fatty Acids
n=21 Participants
The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.
Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks.
|
|---|---|---|
|
Children's Depressive Rating Scale - Revised (CDRS-R)
Baseline
|
50.2 units on a scale
Standard Deviation 8.91
|
49.5 units on a scale
Standard Deviation 8.20
|
|
Children's Depressive Rating Scale - Revised (CDRS-R)
10 weeks
|
35.2 units on a scale
Standard Deviation 10.57
|
36.5 units on a scale
Standard Deviation 10.01
|
SECONDARY outcome
Timeframe: baseline and 10-week treatment phasePopulation: 3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results
a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Outcome measures
| Measure |
Corn Oil
n=27 Participants
The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.
Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell.
|
Omega-3 Fatty Acids
n=21 Participants
The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.
Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks.
|
|---|---|---|
|
Clinician's Global Improvement Scale (CGI)
Baseline
|
4.0 units on a scale
Standard Deviation 0.50
|
4.0 units on a scale
Standard Deviation 0.34
|
|
Clinician's Global Improvement Scale (CGI)
10 weeks
|
3.2 units on a scale
Standard Deviation 0.75
|
3.4 units on a scale
Standard Deviation 0.86
|
Adverse Events
Corn Oil
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Omega-3 Fatty Acids
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Corn Oil
n=27 participants at risk
The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.
Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell.
|
Omega-3 Fatty Acids
n=21 participants at risk
The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.
Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin rash
|
3.7%
1/27
3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results
|
0.00%
0/21
3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results
|
Additional Information
Dr. Vilma Gabbay
Icahn School of Medicine at Mount Sinai
Phone: 212-659-1661
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place