Schizophrenia Clinical Trial
Official title:
Safety Study for Infants Who Exposed to Antipsychotics as Fetus
Verified date | November 2011 |
Source | Central South University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: National Natural Science Foundation |
Study type | Observational |
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.
Status | Completed |
Enrollment | 152 |
Est. completion date | May 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 1 Day |
Eligibility |
Inclusion Criteria: - newborns - exposed to antipsychotic as fetus - no exposed to antipsychotic Exclusion Criteria: - malformation - liver dysfunction - renal dysfunction - cardiovascular diseases |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | Mental Health Institute | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
Central South University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | evidence of negative effects of antipsychotic on infant mental development confirmed by Bayley Scales of Infant and Toddler Development | one year | No |
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