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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01479400
Recruitment Status : Completed
First Posted : November 24, 2011
Last Update Posted : November 24, 2011
Information provided by (Responsible Party):
Renrong Wu, 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.

Condition or disease

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 Type : Observational
Actual Enrollment : 152 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Safety Study for Infants Who Exposed to Antipsychotics as Fetus
Study Start Date : October 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

infants who were exposed to antipsychotics as fetus
infants who were not exposed to antipsychotics as fetus

Primary Outcome Measures :
  1. evidence of negative effects of antipsychotic on infant mental development confirmed by Bayley Scales of Infant and Toddler Development [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Inclusion Criteria:

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

Exclusion Criteria:

  • malformation
  • liver dysfunction
  • renal dysfunction
  • cardiovascular diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01479400

China, Hunan
Mental Health Institute
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Central South University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Renrong Wu, primary investigator, Central South University Identifier: NCT01479400     History of Changes
Other Study ID Numbers: WU30971052
First Posted: November 24, 2011    Key Record Dates
Last Update Posted: November 24, 2011
Last Verified: November 2011

Keywords provided by Renrong Wu, Central South University:
infant development

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs