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The Role Of Omega-3 Fatty Acids In Adolescent Depression

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ClinicalTrials.gov Identifier: NCT00962598
Recruitment Status : Completed
First Posted : August 20, 2009
Results First Posted : May 24, 2017
Last Update Posted : April 24, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Vilma Gabbay, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depressive Disorder, Major
Interventions Drug: Omega 3 Fatty Acids
Dietary Supplement: Corn oil
Enrollment 16
Recruitment Details Recruitment began in December 2005, with enrollment from January 2006 to June 2013. Participants recruited for this imaging from another study, GCO 12-1321.
Pre-assignment Details  
Arm/Group Title Corn Oil Omega-3 Fatty Acids
Hide Arm/Group Description 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.

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.

Period Title: Overall Study
Started 7 9
Completed 7 9
Not Completed 0 0
Arm/Group Title Corn Oil Omega-3 Fatty Acids Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 7 9 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 9 participants 16 participants
16.62  (3.087) 16.51  (2.756) 16.56  (2.805)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 9 participants 16 participants
Female
2
  28.6%
7
  77.8%
9
  56.3%
Male
5
  71.4%
2
  22.2%
7
  43.8%
1.Primary Outcome
Title ACC Glx/Water
Hide Description 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.
Time Frame baseline and 10-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Corn Oil Omega-3 Fatty Acids
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: ratio * 10^-4
ACC Glx/Water Baseline 19.21  (5.173) 18.99  (2.989)
ACC Glx/Water 10 weeks 19.28  (3.339) 20.61  (5.201)
2.Primary Outcome
Title ACC GABA/Water
Hide Description The 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.
Time Frame baseline and 10-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Corn Oil Omega-3 Fatty Acids
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: ratio * 10^-4
ACC GABA/Water Baseline 28.37  (4.097) 25.28  (2.845)
ACC GABA/Water 10 weeks 28.93  (5.200) 28.84  (3.512)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Corn Oil Omega-3 Fatty Acids
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Corn Oil Omega-3 Fatty Acids
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/9 (0.00%) 
Hide Serious Adverse Events
Corn Oil Omega-3 Fatty Acids
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Corn Oil Omega-3 Fatty Acids
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/9 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Vilma Gabbay
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-659-1661
EMail: vilma.gabbay@mssm.edu
Layout table for additonal information
Responsible Party: Vilma Gabbay, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00962598    
Other Study ID Numbers: GCO 12-1321
R21AT004576-01 ( U.S. NIH Grant/Contract )
First Submitted: August 19, 2009
First Posted: August 20, 2009
Results First Submitted: April 17, 2017
Results First Posted: May 24, 2017
Last Update Posted: April 24, 2018