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Omega-3 Fatty Acids as Adjunct Treatment for Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00511810
Recruitment Status : Completed
First Posted : August 6, 2007
Results First Posted : December 4, 2014
Last Update Posted : May 27, 2016
Sponsor:
Collaborator:
The Inflammation Research Foundation
Information provided by (Responsible Party):
Robert McNamara, University of Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Low Dose Fish Oil
Drug: High Dose Fish Oil
Enrollment 20
Recruitment Details Recruitment started in August, 2007 at the University of Cincinnati, Medical Sciences Building.
Pre-assignment Details A total of 24 patients were screened and 20 patients met inclusion criteria.
Arm/Group Title High Dose Fish Oil Low Dose Fish Oil
Hide Arm/Group Description

Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)

High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)

Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)

Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)

Period Title: Overall Study
Started 8 12
Completed 7 7 [1]
Not Completed 1 5
Reason Not Completed
Lost to Follow-up             1             2
Lack of Efficacy             0             2
Refused second scn             0             1
[1]
2 terminated for worsening symptoms;1 refused a scan;2 lost to follow up (could not be contacted)
Arm/Group Title High Dose Fish Oil Low Dose Fish Oil Total
Hide Arm/Group Description

Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)

High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)

Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)

Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)

Total of all reporting groups
Overall Number of Baseline Participants 8 12 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 12 participants 20 participants
<=18 years
8
 100.0%
12
 100.0%
20
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 12 participants 20 participants
13.3  (3.2) 16.7  (2.9) 15.0  (3.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 12 participants 20 participants
Female
5
  62.5%
9
  75.0%
14
  70.0%
Male
3
  37.5%
3
  25.0%
6
  30.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 12 participants 20 participants
8 12 20
Depression Score   [1] 
Mean (Standard Deviation)
Unit of measure:  CDRS-R Score
Number Analyzed 8 participants 12 participants 20 participants
33.5  (3.1) 31.9  (6.5) 32.7  (4.8)
[1]
Measure Description: Patients were required to have a baseline score of >28 and <40 on the Children Depression Rating Scale-Revised (CDRS-R) despite being administered a standard therapeutic dose of an SSRI for a minimum of 6 weeks.
1.Primary Outcome
Title Mood Symptoms Ratings
Hide Description Depression symptom severity was determined with the Children’s Depression Rating Scale-Revised (CDRS-R), which is a brief rating scale based on a semi-structured interview with the child. It is a 17-item observer-rated questionnaire where the 17 symptom areas are rated on a 6- or 7-point scale. Total score ranges from a low (not depressed) of 17 to a maximum (very depressed) of 108. Remission was defined as a CDRS-R score of <28. (The total score is the sum of the ratings on each of the 17 items.)
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline CDRS-R: High Dose Fish Oil Baseline CDRS-R: Low Dose Fish Oil
Hide Arm/Group Description:
CDRS-R scores were computed for High Fish Oil groups.
CDRS-R scores were computed for Low Fish Oil groups.
Overall Number of Participants Analyzed 8 12
Mean (Standard Deviation)
Unit of Measure: CDRS-R score
33.0  (1.5) 33.1  (1.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Dose Fish Oil Low Dose Fish Oil
Hide Arm/Group Description

Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)

High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)

Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)

Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)

All-Cause Mortality
High Dose Fish Oil Low Dose Fish Oil
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
High Dose Fish Oil Low Dose Fish Oil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      2/12 (16.67%)    
Psychiatric disorders     
Worsening of depressive symptoms  [1]  0/8 (0.00%)  0 2/12 (16.67%)  2
Indicates events were collected by systematic assessment
[1]
Two patients in teh Low Dose Groupt experienced worsening of depressive symptoms.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
High Dose Fish Oil Low Dose Fish Oil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/12 (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: Robert McNamara, PhD
Organization: University of Cincinnati
Phone: 513-558-5601
EMail: robert.mcnamara@uc.edu
Layout table for additonal information
Responsible Party: Robert McNamara, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00511810     History of Changes
Other Study ID Numbers: McNamara Omega3 MDD
First Submitted: August 3, 2007
First Posted: August 6, 2007
Results First Submitted: March 21, 2013
Results First Posted: December 4, 2014
Last Update Posted: May 27, 2016