Clinical trial NCT01479400: Effects of Exposed to Antipsychotics Throughout Pregnancy on Infants Development: A Prospective Study
Official title: Safety Study for Infants Who Exposed to Antipsychotics as Fetus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: antipsychotic
schizophrenia
infant development
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2011-11-24
Enrollment: 152
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 76 infants who were exposed to antipsychotics as fetus was compared to 76 matched control infants who were not exposed to antipsychotics as fetus.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* malformation
* liver dysfunction
* renal dysfunction
* cardiovascular diseases

Primary outcomes:
measure: evidence of negative effects of antipsychotic on infant mental development confirmed by Bayley Scales of Infant and Toddler Development
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Mental Health Institute
state: Hunan
Study officials:
References:
citation: 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.
citation: 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.