Essential Fatty Acids for Major Depression - Full Text View

Sponsored by:	University of Iowa
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00256412

Purpose

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	Intervention
Major Depression	Drug: Eicosapentaenoic acid (EPA) 0.7 grams/day or 1.5 grams/day Drug: Placebo

MedlinePlus related topics: Depression

Drug Information available for: Eicosapentaenoic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Essential Fatty Acids in Management of MDD - A Pilot Study

Further study details as provided by University of Iowa:

Primary Outcome Measures:

Montgomery-Asberg Depression Rating Scale (MADRS) scores [ Time Frame: 4 - 10 weeks ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	October 2005
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo 4 capsules of placebo each day
2: Active Comparator 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.
3: Active Comparator 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.

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Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256412

Locations

United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

University of Iowa

Investigators

Principal Investigator:	William H Coryell, M.D.	University of Iowa
Study Director:	Jess G Fiedorowicz, M.D.	University of Iowa

More Information

No publications provided

Responsible Party:	University of Iowa ( William Coryell )
Study ID Numbers:	IRB-01 200408033
Study First Received:	November 16, 2005
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00256412 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 07, 2009