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The Role Of Omega-3 Fatty Acids In Adolescent Depression

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Vilma Gabbay, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT00962598
First received: August 19, 2009
Last updated: April 17, 2017
Last verified: April 2017
Results First Received: April 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Depressive Disorder, Major
Interventions: Drug: Omega 3 Fatty Acids
Dietary Supplement: Corn oil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began in December 2005, with enrollment from January 2006 to June 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Corn Oil   Omega-3 Fatty Acids
STARTED   27   24 
COMPLETED   21   18 
NOT COMPLETED   6   6 
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 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
3 participants in Omega-3 Fatty Acids arm were discontinued prior to receiving treatment and were not included in the data results

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Corn Oil   Omega-3 Fatty Acids   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   21   48 
Age 
[Units: Years]
Mean (Standard Deviation)
 16.34  (1.981)   15.68  (2.19)   16.05  (2.079) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      16  59.3%      12  57.1%      28  58.3% 
Male      11  40.7%      9  42.9%      20  41.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Children's Depressive Rating Scale - Revised (CDRS-R)   [ Time Frame: baseline and 10-weeks ]

2.  Secondary:   Clinician's Global Improvement Scale (CGI)   [ Time Frame: baseline and 10-week treatment phase ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: vilma.gabbay@mssm.edu



Responsible Party: Vilma Gabbay, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00962598     History of Changes
Other Study ID Numbers: GCO 12-1321
R21AT004576-01 ( US NIH Grant/Contract Award Number )
Study First Received: August 19, 2009
Results First Received: April 17, 2017
Last Updated: April 17, 2017