NCT00256412

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 5, 2008

Status Verified

June 1, 2008

Enrollment Period

2 years

First QC Date

November 16, 2005

Last Update Submit

June 3, 2008

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

  • Montgomery-Asberg Depression Rating Scale (MADRS) scores

    4 - 10 weeks

Study Arms (3)

1

PLACEBO COMPARATOR
Drug: Placebo

2

ACTIVE COMPARATOR

Low Dose

Drug: Eicosapentaenoic acid (EPA) 0.7 grams/day or 1.5 grams/day

3

ACTIVE COMPARATOR

High Dose

Drug: Eicosapentaenoic acid (EPA) 0.7 grams/day or 1.5 grams/day

Interventions

Eicosapentaenoic acid (EPA) 0.7 grams/day or 1.5 grams/dayDRUG

Placebo and Omega 3 capsules. All participants receive 4 capsules with either 0, 2, or 4 capsules containing omega 3.

23
PlaceboDRUG

4 capsules of placebo each day

1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

  • Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.

    PMID: 34817851DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Eicosapentaenoic Acid

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsEicosanoidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • William H Coryell, M.D.

    University of Iowa

    PRINCIPAL INVESTIGATOR

  • Jess G Fiedorowicz, M.D.

    University of Iowa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2005

First Posted

November 21, 2005

Study Start

October 1, 2005

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

June 5, 2008

Record last verified: 2008-06

Locations

US(1)