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OpenTrials
Completed

NCT Number: NCT01479400

Effects of Exposed to Antipsychotics Throughout Pregnancy on Infants Development: A Prospective Study

The primary aim of this prospective study is to evaluate the effect of antipsychotics on infant development especially neurobehavioral development which evaluated by the Bayley-III when mothers are treated with antipsychotics throughout their pregnancy.

Completed

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Key information

Age range

1 day–1 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Mental Health Institute

Changsha, Hunan, 410011, China

About this study

The neurodevelopmental effect of antipsychotics on fetus has always been a major concern for women who need antipsychotic treatments and are in their reproductive years. The fear of harmful effects from antipsychotic on fetus and unplanned pregnancy commonly causes non-adherence to treatments. Even for those who are willing to maintain their antipsychotic treatments during pregnancy, the fear of potential harmful effects from antipsychotic on fetus can still exist. It is well known that non-adherence to antipsychotic treatments in patients with schizophrenia can cause most to relapse and poor treatment response. The consequences of relapse not only increase personal suffering, but also increase family and societal burden.Clearly, it is important to evaluate the safety of antipsychotics during pregnancy. However, up to now, most information about antipsychotics on reproductive safety and the effects on infant development come from case reports, case series, and retrospective studies.So the study was to investigate the developmental effects of antipsychotics on infants who were exposed to as fetus.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newborns
  • exposed to antipsychotic as fetus
  • no exposed to antipsychotic

Exclusion criteria

  • malformation
  • liver dysfunction
  • renal dysfunction
  • cardiovascular diseases

Treatment and study plan

Primary outcomes

  1. evidence of negative effects of antipsychotic on infant mental development confirmed by Bayley Scales of Infant and Toddler Development

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Central South University

Other

Registry information

Official study title

Safety Study for Infants Who Exposed to Antipsychotics as Fetus

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Nov 24, 2011
Registry last updated
Nov 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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