Omega-3 Fatty Acids for Major Depressive Disorder During Pregnancy

Sponsor

National Science Council, Taiwan (Other)

Overall Status

Completed

CT.gov ID

NCT00618865

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder	Dietary Supplement: Omega-3 fatty acids	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Omega-3 Polyunsaturated Fatty Acids in Women With Major Depressive Disorders During Pregnancy

Study Start Date :

Jun 1, 2004

Actual Primary Completion Date :

Jun 1, 2004

Actual Study Completion Date :

Jun 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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
Placebo Comparator: 2 Placebo (olive oil ethyl esters)	Dietary Supplement: Omega-3 fatty acids

Arm

Intervention/Treatment

Experimental: 1

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

Placebo Comparator: 2

Placebo (olive oil ethyl esters)

Dietary Supplement: Omega-3 fatty acids

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.