Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Carney, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00116857
First received: June 30, 2005
Last updated: September 11, 2012
Last verified: September 2012
Results First Received: July 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cardiovascular Diseases
Depression
Heart Diseases
Myocardial Infarction
Angina, Unstable
Interventions: Drug: Sertraline/omega-3
Drug: Sertraline/Corn Oil

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sertraline Plus Omega-3 Supplement Sertraline 50mg 1 tablet by mouth everyday. Plus Omega-3 supplement capsules 2g by mouth everyday.
Sertraline/Corn Oil Sertraline 50mg 1 tablet by mouth everyday. Plus corn oil placebo capsules 2 g by mouth everyday.

Participant Flow:   Overall Study
    Sertraline Plus Omega-3 Supplement     Sertraline/Corn Oil  
STARTED     62     60  
COMPLETED     59     56  
NOT COMPLETED     3     4  



  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.
No text entered.

Reporting Groups
  Description
Sertraline Plus Omega-3 Supplement Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
Sertraline/Corn Oil Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
Total Total of all reporting groups

Baseline Measures
    Sertraline Plus Omega-3 Supplement     Sertraline/Corn Oil     Total  
Number of Participants  
[units: participants]
  62     60     122  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     50     48     98  
>=65 years     12     12     24  
Age  
[units: years]
Mean ± Standard Deviation
  58.1  ± 9.4     58.6  ± 8.5     58.4  ± 9.0  
Gender  
[units: participants]
     
Female     22     19     41  
Male     40     41     81  
Region of Enrollment  
[units: participants]
     
United States     62     60     122  



  Outcome Measures

1.  Primary:   Beck Depression Inventory-II   [ Time Frame: Measured at Baseline and 10 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robert M. Carney, Ph.D.
Organization: Washington University School of Medicine
phone: 314-286-1313
e-mail: carneyr@bmc.wustl.edu


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Robert Carney, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00116857     History of Changes
Other Study ID Numbers: 186, R01HL076808
Study First Received: June 30, 2005
Results First Received: July 3, 2012
Last Updated: September 11, 2012
Health Authority: United States: Food and Drug Administration