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

This study is not yet open for participant recruitment.

Verified by Sheba Medical Center, January 2009

First Received: January 7, 2009 No Changes Posted

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00818727

Purpose

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.

Condition
Bone Density

Drug Information available for: Serotonin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

bone density [ Time Frame: 1 month ] [ Designated as safety issue: No ]
bone density [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40
Study Start Date:	February 2009
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	up to 7 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Healthy term newborn infants to mothers treated with SSRI and healthy controls. bone density mesurment will be applied on the 1-7 days of life.

Criteria

Inclusion Criteria:

Term newborn infants to mothers treated with SSRI and healthy controls

Exclusion Criteria:

Preterms, major congenital malformations.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	sheba medical center ( Dr.Ayala Maayan )
Study ID Numbers:	SHEBA-09-5435-AM-CTIL
Study First Received:	January 7, 2009
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00818727 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

Bone density
SSRI
newborn infants

Study placed in the following topic categories:

Neurotransmitter Agents
Serotonin Uptake Inhibitors
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009