Effects of Exposed to Antipsychotics Throughout Pregnancy on Infants Development: A Prospective Study
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Purpose
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.
| Condition |
|---|
|
Schizophrenia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Safety Study for Infants Who Exposed to Antipsychotics as Fetus |
- evidence of negative effects of antipsychotic on infant mental development confirmed by Bayley Scales of Infant and Toddler Development [ Time Frame: one year ] [ Designated as safety issue: No ]
| Enrollment: | 152 |
| Study Start Date: | October 2007 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| infants who were exposed to antipsychotics as fetus |
| infants who were not exposed to antipsychotics as fetus |
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| Ages Eligible for Study: | up to 1 Day |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
76 infants who were exposed to antipsychotics as fetus was compared to 76 matched control infants who were not exposed to antipsychotics as fetus.
Inclusion Criteria:
- newborns
- exposed to antipsychotic as fetus
- no exposed to antipsychotic
Exclusion Criteria:
- malformation
- liver dysfunction
- renal dysfunction
- cardiovascular diseases
Contacts and Locations More Information
No publications provided
| Responsible Party: | Renrong Wu, primary investigator, Central South University |
| ClinicalTrials.gov Identifier: | NCT01479400 History of Changes |
| Other Study ID Numbers: | WU30971052 |
| Study First Received: | November 16, 2011 |
| Last Updated: | November 22, 2011 |
| Health Authority: | China: National Natural Science Foundation |
Keywords provided by Central South University:
|
antipsychotic schizophrenia infant development |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 23, 2013