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Omega-3 Fatty Acids for Major Depressive Disorder During Pregnancy

This study has been completed.
Sponsor:
Information provided by:
National Science Council, Taiwan
ClinicalTrials.gov Identifier:
NCT00618865
First received: February 8, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  Purpose

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 Intervention
Depressive Disorder
 Dietary Supplement: Omega-3 fatty acids

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Omega-3 Polyunsaturated Fatty Acids in Women With Major Depressive Disorders During Pregnancy

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by National Science Council, Taiwan:

Enrollment: 36
Study Start Date: June 2004
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by National Science Council, Taiwan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kuan-Pin Su, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT00618865     History of Changes
Other Study ID Numbers: NSC 93-2320-B-039-001
Study First Received: February 8, 2008
Last Updated: February 8, 2008
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Science Council, Taiwan:
Omega-3 Fatty Acids
Major Depressive Disorder
Pregnancy
 Women during pregnancy and after childbirth are more vulnerable to psychiatric disorders
Pharmacotherapy 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.

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

ClinicalTrials.gov processed this record on May 19, 2013