search
Back to results

Omega-3 Fatty Acids for Major Depressive Disorder During Pregnancy

Primary Purpose

Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Omega-3 fatty acids
Sponsored by
National Science Council, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring 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.

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

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

    Placebo (olive oil ethyl esters)

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 8, 2008
    Last Updated
    February 8, 2008
    Sponsor
    National Science Council, Taiwan
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00618865
    Brief Title
    Omega-3 Fatty Acids for Major Depressive Disorder During Pregnancy
    Official Title
    Omega-3 Polyunsaturated Fatty Acids in Women With Major Depressive Disorders During Pregnancy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    June 2004 (Actual)
    Study Completion Date
    June 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Science Council, Taiwan

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depressive Disorder
    Keywords
    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.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    omega-3 fatty acid with 2.2 g of eicosapentanoic acid (EPA) and 1.2 g of docosahexanoic acid (DHA)
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo (olive oil ethyl esters)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Omega-3 fatty acids

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18370571
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Omega-3 Fatty Acids for Major Depressive Disorder During Pregnancy

    We'll reach out to this number within 24 hrs