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Essential Fatty Acids for Major Depression

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: NCT00256412
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : June 5, 2008
Sponsor:
Information provided by:
University of Iowa

Brief Summary:

This is a research study to determine whether omega-3 fatty acid supplementation, when taken with the antidepressant medication escitalopram (Lexapro), helps to improve depressive symptoms in individuals who have major depressive disorder (MDD).

Omega-3 fatty acids are found in foods including walnuts, some fruits and vegetables, and coldwater fish such as herring, mackerel, sturgeon, and anchovies.


Condition or disease Intervention/treatment Phase
Major Depression Drug: Eicosapentaenoic acid (EPA) 0.7 grams/day or 1.5 grams/day Drug: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Essential Fatty Acids in Management of MDD - A Pilot Study
Study Start Date : October 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 1 Drug: Placebo
4 capsules of placebo each day

Active Comparator: 2
Low Dose
Drug: Eicosapentaenoic acid (EPA) 0.7 grams/day or 1.5 grams/day
Placebo and Omega 3 capsules. All participants receive 4 capsules with either 0, 2, or 4 capsules containing omega 3.

Active Comparator: 3
High Dose
Drug: Eicosapentaenoic acid (EPA) 0.7 grams/day or 1.5 grams/day
Placebo and Omega 3 capsules. All participants receive 4 capsules with either 0, 2, or 4 capsules containing omega 3.




Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) scores [ Time Frame: 4 - 10 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. DSM-IV criteria for nonpsychotic MDD
  2. Not currently on antidepressants OR not responding to a stable dose of antidepressants

Exclusion Criteria:

  1. DSM-IV for substance abuse in past month or dependence past year.
  2. Allergy to fish
  3. Bleeding disorder or taking warfarin
  4. Omega-3 supplements for more than three consecutive days in the preceding month
  5. Pregnant
  6. Taking medications (i.e. glucocorticoids) known to produce affective symptoms
  7. History of non-response to escitalopram
  8. DSM-IV for an eating disorder in the preceding year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256412


Locations
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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
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Principal Investigator: William H Coryell, M.D. University of Iowa
Study Director: Jess G Fiedorowicz, M.D. University of Iowa

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Responsible Party: William Coryell, University of Iowa
ClinicalTrials.gov Identifier: NCT00256412     History of Changes
Other Study ID Numbers: IRB-01 200408033
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: June 5, 2008
Last Verified: June 2008
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders