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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00818727
First received: January 7, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Bone Density
Drug Information available for: Serotonin
U.S. FDA Resources

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 ]

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

Keywords provided by Sheba Medical Center:
Bone density
SSRI
newborn infants

Additional relevant MeSH terms:
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013