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

This study has been completed.
Sponsor:
Collaborator:
The Inflammation Research Foundation
Information provided by (Responsible Party):
Robert McNamara, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00511810
First received: August 3, 2007
Last updated: April 29, 2016
Last verified: April 2016
Results First Received: March 21, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: Low Dose Fish Oil
Drug: High Dose Fish 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 started in August, 2007 at the University of Cincinnati, Medical Sciences Building.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 24 patients were screened and 20 patients met inclusion criteria.

Reporting Groups
  Description
High Dose Fish Oil

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)

Low Dose Fish Oil

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)


Participant Flow:   Overall Study
    High Dose Fish Oil     Low Dose Fish Oil  
STARTED     8     12  
COMPLETED     7     7 [1]
NOT COMPLETED     1     5  
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)



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
High Dose Fish Oil

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)

Low Dose Fish Oil

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 Total of all reporting groups

Baseline Measures
    High Dose Fish Oil     Low Dose Fish Oil     Total  
Number of Participants  
[units: participants]
  8     12     20  
Age  
[units: participants]
     
<=18 years     8     12     20  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  13.3  (3.2)     16.7  (2.9)     15.0  (3.05)  
Gender  
[units: participants]
     
Female     5     9     14  
Male     3     3     6  
Region of Enrollment  
[units: participants]
     
United States     8     12     20  
Depression Score [1]
[units: CDRS-R Score]
Mean (Standard Deviation)
  33.5  (3.1)     31.9  (6.5)     32.7  (4.8)  
[1] 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.



  Outcome Measures

1.  Primary:   Mood Symptoms Ratings   [ Time Frame: 10 weeks ]


  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: Robert McNamara, PhD
Organization: University of Cincinnati
phone: 513-558-5601
e-mail: robert.mcnamara@uc.edu



Responsible Party: Robert McNamara, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00511810     History of Changes
Other Study ID Numbers: McNamara Omega3 MDD
Study First Received: August 3, 2007
Results First Received: March 21, 2013
Last Updated: April 29, 2016
Health Authority: United States: Food and Drug Administration