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

Tracking Information
First Received Date ^ICMJE	February 8, 2008
Last Updated Date	February 8, 2008
Start Date ^ICMJE	June 2004
Primary Completion Date	June 2004 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Omega-3 Fatty Acids for Major Depressive Disorder During Pregnancy
Official Title ^ICMJE	Omega-3 Polyunsaturated Fatty Acids in Women With Major Depressive Disorders During Pregnancy
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Depressive Disorder
Intervention ^ICMJE	Dietary Supplement: Omega-3 fatty acids
Study Arm (s)	Experimental: 1 omega-3 fatty acid with 2.2 g of eicosapentanoic acid (EPA) and 1.2 g of docosahexanoic acid (DHA) Intervention: Dietary Supplement: Omega-3 fatty acids Placebo Comparator: 2 Placebo (olive oil ethyl esters) Intervention: Dietary Supplement: Omega-3 fatty acids
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	36
Completion Date	June 2004
Primary Completion Date	June 2004 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	18 Years to 40 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00618865
Other Study ID Numbers ^ICMJE	NSC 93-2320-B-039-001
Has Data Monitoring Committee	No
Responsible Party	Kuan-Pin Su, China Medical University Hospital
Study Sponsor ^ICMJE	National Science Council, Taiwan
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Science Council, Taiwan
Verification Date	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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