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

Completed

• Conditions: Schizophrenia

• Registration Number: NCT01479400
• Lead Sponsor: Central South University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2010-12
• Study Completion: 2011-05
• Status Verified: 2011-11
• Study First Submitted: 2011-11-16
• Study First Submitted QC: 2011-11-22
• Last Update Submitted: 2011-11-22
• Study First Posted: 2011-11-24
• Last Update Posted: 2011-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

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

Exclusion Criteria

• malformation
• liver dysfunction
• renal dysfunction
• cardiovascular diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evidence of negative effects of antipsychotic on infant mental development confirmed by Bayley Scales of Infant and Toddler Development	one year

Trial Locations

Locations (1)

Mental Health Institute; 🇨🇳 Changsha, Hunan, China