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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Keywords

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antipsychotic schizophrenia infant development

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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infants who were exposed to antipsychotics as fetus

No interventions assigned to this group

infants who were not exposed to antipsychotics as fetus

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* malformation
* liver dysfunction
* renal dysfunction
* cardiovascular diseases

Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Renrong Wu

primary investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mental Health Institute

Changsha, Hunan, China

Site Status

Countries

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China

References

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Shao P, Ou J, Peng M, Zhao J, Chen J, Wu R. Effects of Clozapine and other Atypical Antipsychotics on Infants Development Who Were Exposed to as Fetus: A Post-Hoc Analysis. PLoS One. 2015 Apr 24;10(4):e0123373. doi: 10.1371/journal.pone.0123373. eCollection 2015.

Reference Type DERIVED

PMID: 25909513 (View on PubMed)

Peng M, Gao K, Ding Y, Ou J, Calabrese JR, Wu R, Zhao J. Effects of prenatal exposure to atypical antipsychotics on postnatal development and growth of infants: a case-controlled, prospective study. Psychopharmacology (Berl). 2013 Aug;228(4):577-84. doi: 10.1007/s00213-013-3060-6. Epub 2013 Apr 5.