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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Renrong Wu, Central South University
ClinicalTrials.gov Identifier:
NCT01479400
First received: November 16, 2011
Last updated: November 22, 2011
Last verified: November 2011
  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

Resource links provided by NLM:


Further study details as provided by Central South University:

Primary Outcome Measures:
  • 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
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • malformation
  • liver dysfunction
  • renal dysfunction
  • cardiovascular diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479400

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

No publications provided by Central South University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014