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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00618865
Other study ID # NSC 93-2320-B-039-001
Secondary ID
Status Completed
Phase N/A
First received February 8, 2008
Last updated February 8, 2008
Start date June 2004
Est. completion date June 2004

Study information

Verified date February 2008
Source National Science Council, Taiwan
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date June 2004
Est. primary completion date June 2004
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Dietary Supplement:
Omega-3 fatty acids


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Science Council, Taiwan
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