NCT00818727

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
24 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Last Updated

January 8, 2009

Status Verified

January 1, 2009

Enrollment Period

1.9 years

First QC Date

January 7, 2009

Last Update Submit

January 7, 2009

Conditions

Keywords

Bone densitySSRInewborn infants

Outcome Measures

Primary Outcomes (2)

  • bone density

    1 month

  • bone density

    2 years

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Preterms, major congenital malformations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 8, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2011

Last Updated

January 8, 2009

Record last verified: 2009-01