Trial record 4 of 101 for:    Open Studies | "Bone Density"

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
Information provided by:
Sheba Medical Center Identifier:
First received: January 7, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
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.

Bone Density

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

Resource links provided by NLM:

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)

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.

Inclusion Criteria:

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

Exclusion Criteria:

  • Preterms, major congenital malformations.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Dr.Ayala Maayan, sheba medical center 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
newborn infants

Additional relevant MeSH terms:
Serotonin Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents processed this record on May 05, 2016