We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00818727
Recruitment Status : Unknown
Verified January 2009 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 8, 2009
Last Update Posted : January 8, 2009
Information provided by:
Sheba Medical Center

Brief 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.

Condition or disease
Bone Density

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : February 2009
Estimated Primary Completion Date : January 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. bone density [ Time Frame: 1 month ]
  2. bone density [ Time Frame: 2 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
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.

Responsible Party: Dr.Ayala Maayan, sheba medical center
ClinicalTrials.gov Identifier: NCT00818727     History of Changes
Other Study ID Numbers: SHEBA-09-5435-AM-CTIL
First Posted: January 8, 2009    Key Record Dates
Last Update Posted: January 8, 2009
Last Verified: January 2009

Keywords provided by Sheba Medical Center:
Bone density
newborn infants

Additional relevant MeSH terms:
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs