NCT01479400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed
Last Updated

November 24, 2011

Status Verified

November 1, 2011

Enrollment Period

3.2 years

First QC Date

November 16, 2011

Last Update Submit

November 22, 2011

Conditions

Schizophrenia

Keywords

antipsychoticschizophreniainfant development

Outcome Measures

Primary Outcomes (1)

  • evidence of negative effects of antipsychotic on infant mental development confirmed by Bayley Scales of Infant and Toddler Development

    one year

Study Arms (2)

infants who were exposed to antipsychotics as fetus

infants who were not exposed to antipsychotics as fetus

Eligibility Criteria

Age1 Day - 1 Day
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • malformation
  • liver dysfunction
  • renal dysfunction
  • cardiovascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Institute

Changsha, Hunan, 410011, China

Location

Related Publications (2)

  • 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.

    PMID: 25909513DERIVED

  • 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.

    PMID: 23559219DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
primary investigator

Study Record Dates

First Submitted

November 16, 2011

First Posted

November 24, 2011

Study Start

October 1, 2007

Primary Completion

December 1, 2010

Study Completion

May 1, 2011

Last Updated

November 24, 2011

Record last verified: 2011-11

Locations

CN(1)