NCT00618865

Brief Summary

Whether high-dose omega-3 fatty acids supplement would be an effective treatment in patients with major depressive disorder during pregnancy and breast-feeding.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2004

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

June 1, 2004

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
Last Updated

February 20, 2008

Status Verified

February 1, 2008

Enrollment Period

Same day

First QC Date

February 8, 2008

Last Update Submit

February 8, 2008

Conditions

Depressive Disorder

Keywords

Omega-3 Fatty AcidsMajor Depressive DisorderPregnancyWomen during pregnancy and after childbirth are more vulnerable to psychiatric disordersPharmacotherapy for depression during pregnancy is a clinical dilemma.Omega-3 polyunsaturated fatty acids (PUFAs) might be a promising alternative of treatment for pregnant women with depression.

Study Arms (2)

1

EXPERIMENTAL

omega-3 fatty acid with 2.2 g of eicosapentanoic acid (EPA) and 1.2 g of docosahexanoic acid (DHA)

Dietary Supplement: Omega-3 fatty acids

2

PLACEBO COMPARATOR

Placebo (olive oil ethyl esters)

Dietary Supplement: Omega-3 fatty acids

Interventions

Omega-3 fatty acidsDIETARY_SUPPLEMENT
12

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Eligible participants were pregnant women, aged 18 to 40 years, with major depressive disorder onset between their 16th week (second trimester) and 32nd week (third trimester) of gestation at the Department of Obstetrics.

You may not qualify if:

  • Subjects were excluded with a DSM-IV diagnosis of bipolar disorders, psychotic disorders, substance abuse or dependence for at least 3 months, or any Axis-II diagnosis of borderline or antisocial personality disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Su KP, Huang SY, Chiu TH, Huang KC, Huang CL, Chang HC, Pariante CM. Omega-3 fatty acids for major depressive disorder during pregnancy: results from a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2008 Apr;69(4):644-51. doi: 10.4088/jcp.v69n0418.

    PMID: 18370571DERIVED

MeSH Terms

Conditions

Depressive DisorderDepressive Disorder, Major

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 8, 2008

First Posted

February 20, 2008

Study Start

June 1, 2004

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

February 20, 2008

Record last verified: 2008-02