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Omega-3 Fatty Acids in Adolescent Depression

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ClinicalTrials.gov Identifier: NCT00312897
Recruitment Status : Completed
First Posted : April 11, 2006
Results First Posted : February 15, 2018
Last Update Posted : April 19, 2018
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
National Center for Research Resources (NCRR)
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 Adolescent Depression
Interventions Drug: Omega-3 Fatty Acids
Drug: corn oil
Enrollment 57
Recruitment Details Recruitment began in December 2005, with enrollment from January 2006 to June 2013
Pre-assignment Details 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.
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. Acids: 10 wk treatment period

Period Title: Overall Study
Started 27 24
Completed 21 18
Not Completed 6 6
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             2             0
Physician Decision             1             0
Withdrawal by Subject             1             3
Pregnancy             1             0
discontinued prior to getting treatment             0             3
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 27 21 48
Hide Baseline Analysis Population Description
3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 21 participants 48 participants
16.34  (1.981) 15.68  (2.19) 16.05  (2.079)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 21 participants 48 participants
Female
16
  59.3%
12
  57.1%
28
  58.3%
Male
11
  40.7%
9
  42.9%
20
  41.7%
1.Primary Outcome
Title Children's Depressive Rating Scale - Revised (CDRS-R)
Hide Description 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).
Time Frame baseline and 10-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results
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 27 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 50.2  (8.91) 49.5  (8.20)
10 weeks 35.2  (10.57) 36.5  (10.01)
2.Secondary Outcome
Title Clinician's Global Improvement Scale (CGI)
Hide Description 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.
Time Frame baseline and 10-week treatment phase
Hide Outcome Measure Data
Hide Analysis Population Description
3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results
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 27 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 4.0  (0.50) 4.0  (0.34)
10 weeks 3.2  (0.75) 3.4  (0.86)
Time Frame [Not Specified]
Adverse Event Reporting Description 3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results
 
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   0/27 (0.00%)   0/21 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Corn Oil Omega-3 Fatty Acids
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events 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   1/27 (3.70%)   0/21 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin rash  1/27 (3.70%)  0/21 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Vilma Gabbay
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-659-1661
Responsible Party: Vilma Gabbay, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00312897     History of Changes
Other Study ID Numbers: GCO# 12-1321
R21AT002395-01A2 ( U.S. NIH Grant/Contract )
First Submitted: April 7, 2006
First Posted: April 11, 2006
Results First Submitted: April 17, 2017
Results First Posted: February 15, 2018
Last Update Posted: April 19, 2018