Essential Fatty Acids for Major Depression

This study has been completed.
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00256412
First received: November 16, 2005
Last updated: June 3, 2008
Last verified: June 2008
  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

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
Official Title: Essential Fatty Acids in Management of MDD - A Pilot Study

Resource links provided by NLM:


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
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  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: William Coryell, University of Iowa
ClinicalTrials.gov Identifier: NCT00256412     History of Changes
Other Study ID Numbers: IRB-01 200408033
Study First Received: November 16, 2005
Last Updated: June 3, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014