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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 16, 2014