Trial Outcomes & Findings for The Role Of Omega-3 Fatty Acids In Adolescent Depression (NCT NCT00962598)
NCT ID: NCT00962598
Last Updated: 2018-04-24
Results Overview
The data reflects the ratio of Glutamine-Glutamate and water in the brain (ratio divided by 10000 for analysis purposes). Glutamate is a precursor to Glutamine, an amino acid which functions as an excitatory neurotransmitter in the human brain.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
baseline and 10-weeks
Results posted on
2018-04-24
Participant Flow
Recruitment began in December 2005, with enrollment from January 2006 to June 2013. Participants recruited for this imaging from another study, GCO 12-1321.
Participant milestones
| Measure |
Corn Oil
Corn oil: The dosage 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.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role Of Omega-3 Fatty Acids In Adolescent Depression
Baseline characteristics by cohort
| Measure |
Corn Oil
n=7 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=9 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=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.62 years
STANDARD_DEVIATION 3.087 • n=5 Participants
|
16.51 years
STANDARD_DEVIATION 2.756 • n=7 Participants
|
16.56 years
STANDARD_DEVIATION 2.805 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 10-weeksThe data reflects the ratio of Glutamine-Glutamate and water in the brain (ratio divided by 10000 for analysis purposes). Glutamate is a precursor to Glutamine, an amino acid which functions as an excitatory neurotransmitter in the human brain.
Outcome measures
| Measure |
Corn Oil
n=7 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=9 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.
|
|---|---|---|
|
ACC Glx/Water
ACC Glx/Water Baseline
|
19.21 ratio * 10^-4
Standard Deviation 5.173
|
18.99 ratio * 10^-4
Standard Deviation 2.989
|
|
ACC Glx/Water
ACC Glx/Water 10 weeks
|
19.28 ratio * 10^-4
Standard Deviation 3.339
|
20.61 ratio * 10^-4
Standard Deviation 5.201
|
PRIMARY outcome
Timeframe: baseline and 10-weeksThe ratio of gamma-Aminobutyric acid (GABA) and water in the brain (ratio divided by 10000 for analysis purposes), that was observed in MR Spectroscopy. GABA, an amino acid produced by cells of the central nervous system, is an inhibitory neurotransmitter, prominent in the human brain.
Outcome measures
| Measure |
Corn Oil
n=7 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=9 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.
|
|---|---|---|
|
ACC GABA/Water
ACC GABA/Water Baseline
|
28.37 ratio * 10^-4
Standard Deviation 4.097
|
25.28 ratio * 10^-4
Standard Deviation 2.845
|
|
ACC GABA/Water
ACC GABA/Water 10 weeks
|
28.93 ratio * 10^-4
Standard Deviation 5.200
|
28.84 ratio * 10^-4
Standard Deviation 3.512
|
Adverse Events
Corn Oil
Serious events: 0 serious events
Other events: 0 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
Adverse event data not reported
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