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Trial record 37 of 229 for:    "Depressive Disorder" [DISEASE] | ( Map: Missouri, United States )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00116857
Recruitment Status : Completed
First Posted : July 1, 2005
Results First Posted : September 12, 2012
Last Update Posted : September 12, 2012
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert Carney, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
Enrollment 122
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sertraline Plus Omega-3 Supplement Sertraline/Corn Oil
Hide Arm/Group Description Sertraline 50mg 1 tablet by mouth everyday. Plus Omega-3 supplement capsules 2g by mouth everyday. Sertraline 50mg 1 tablet by mouth everyday. Plus corn oil placebo capsules 2 g by mouth everyday.
Period Title: Overall Study
Started 62 60
Completed 59 56
Not Completed 3 4
Arm/Group Title Sertraline Plus Omega-3 Supplement Sertraline/Corn Oil Total
Hide Arm/Group Description Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday. Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday. Total of all reporting groups
Overall Number of Baseline Participants 62 60 122
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 60 participants 122 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
50
  80.6%
48
  80.0%
98
  80.3%
>=65 years
12
  19.4%
12
  20.0%
24
  19.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 60 participants 122 participants
58.1  (9.4) 58.6  (8.5) 58.4  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 60 participants 122 participants
Female
22
  35.5%
19
  31.7%
41
  33.6%
Male
40
  64.5%
41
  68.3%
81
  66.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 62 participants 60 participants 122 participants
62 60 122
1.Primary Outcome
Title Beck Depression Inventory-II
Hide Description Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment.
Time Frame Measured at Baseline and 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline Plus Omega-3 Supplement Sertraline/Corn Oil
Hide Arm/Group Description:
Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
Overall Number of Participants Analyzed 62 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.1  (10.2) 14.8  (9.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sertraline Plus Omega-3 Supplement Sertraline/Corn Oil
Hide Arm/Group Description Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday. Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
All-Cause Mortality
Sertraline Plus Omega-3 Supplement Sertraline/Corn Oil
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sertraline Plus Omega-3 Supplement Sertraline/Corn Oil
Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sertraline Plus Omega-3 Supplement Sertraline/Corn Oil
Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)   0/60 (0.00%) 
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
Responsible Party: Robert Carney, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00116857     History of Changes
Other Study ID Numbers: 186
R01HL076808 ( U.S. NIH Grant/Contract )
First Submitted: June 30, 2005
First Posted: July 1, 2005
Results First Submitted: July 3, 2012
Results First Posted: September 12, 2012
Last Update Posted: September 12, 2012