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

Safety Study for Infants Who Exposed to Antipsychotics as Fetus

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01479400

Enrollment

152

Registered

2011-11-24

Start date

2007-10-31

Completion date

2011-05-31

Last updated

2011-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

antipsychotic, schizophrenia, infant development

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 1 Days

Healthy volunteers

Yes

Inclusion criteria

* newborns * exposed to antipsychotic as fetus * no exposed to antipsychotic

Exclusion criteria

* malformation * liver dysfunction * renal dysfunction * cardiovascular diseases

Design outcomes

Primary

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

Countries

China

Outcome results