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NCT00818727 Clinical Trial

Bone Density of Newborn Infants to Mothers Treated With Selective Serotonin Reuptake Inhibitor (SSRI)

Bone Density Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00818727
Other study ID # SHEBA-09-5435-AM-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 7, 2009
Last updated January 7, 2009
Start date February 2009

Study information
Verified date January 2009
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

SSRI treatment in adults was found to decrease bone density. The use of SSRI among pregnant women with depression or anxiety is extendent and raising. The effect of bone density of the infants was not yet evaluated.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 7 Days
Eligibility Inclusion Criteria:

- Term newborn infants to mothers treated with SSRI and healthy controls

Exclusion Criteria:

- Preterms, major congenital malformations.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary bone density 1 month No
Primary bone density 2 years No
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