SchizophreniaNCT01479400
Effects of Exposed to Antipsychotics Throughout Pregnancy on Infants Development: A Prospective Study
An observational study of Schizophrenia, run by Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- Oct 2007to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 to 1 day
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- newborns
- exposed to antipsychotic as fetus
- no exposed to antipsychotic
Who cannot join
- malformation
- liver dysfunction
- renal dysfunction
- cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety Study for Infants Who Exposed to Antipsychotics as Fetus
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.
Read the 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.
- Conditions
- Schizophrenia
- Keywords
- antipsychotic, schizophrenia, infant development
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| infants who were exposed to antipsychotics as fetus | Not described | |
| infants who were not exposed to antipsychotics as fetus | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
evidence of negative effects of antipsychotic on infant mental development confirmed by Bayley Scales of Infant and Toddler Development
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startOct 2007
- Primary completionDec 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renrong Wu, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479400
- Sponsor's protocol ID
- WU30971052
- Status last verified
- Nov 2011
- First submitted
- 16 Nov 2011
- Last updated
- 24 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25909513Peng 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.
PubMed 23559219
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study for Infants Who Exposed to Antipsychotics as Fetus
- ClinicalTrials.gov ID
- NCT01479400
- Acronym / sponsor ID
- WU30971052
- Conditions
- Schizophrenia
- Keywords
- antipsychotic, schizophrenia, infant development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 24 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infants who were exposed to antipsychotics as fetus | – | – |
| infants who were not exposed to antipsychotics as fetus | – | – |
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- newborns
- exposed to antipsychotic as fetus
- no exposed to antipsychotic
Key exclusion criteria (4 listed)
- malformation
- liver dysfunction
- renal dysfunction
- cardiovascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evidence of negative effects of antipsychotic on infant mental development confirmed by Bayley Scales of Infant and Toddler Development
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2011.
- Derived from this study: PubMed 25909513Shao 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.
- Derived from this study: PubMed 23559219Peng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evidence of negative effects of antipsychotic on infant mental development confirmed by Bayley Scales of Infant and Toddler Development (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01479400, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2011.