National Pregnancy Registry for Atypical Antipsychotics
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ClinicalTrials.gov Identifier: NCT01246765 |
Recruitment Status :
Recruiting
First Posted : November 23, 2010
Last Update Posted : August 31, 2021
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Condition or disease |
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Use of Atypical Antipsychotics During Pregnancy Schizophrenia Bipolar Disorder Depression Schizoaffective Disorder |
The National Pregnancy Registry for Atypical Antipsychotics is dedicated to evaluating the safety of atypical antipsychotic medications that may be taken by women during pregnancy to treat a wide range of mood, anxiety, or psychiatric disorders. The primary goal of this Registry is to determine the frequency of major malformations, such as heart defects, cleft lip, or neural tube defects, in infants exposed to atypical antipsychotics during pregnancy. We are currently studying the following medications:
- Abilify (aripiprazole)
- Aristada (aripiprazole lauroxil)
- Clozaril (clozapine)
- Fanapt (iloperidone)
- Geodon (ziprasidone)
- Invega (paliperidone)
- Latuda (lurasidone)
- Rexulti (brexpiprazole)
- Risperdal (risperidone)
- Saphris (asenapine)
- Seroquel (quetiapine)
- Zyprexa (olanzapine)
- Vraylar (cariprazine)
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 2500 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 15 Months |
Official Title: | National Pregnancy Registry for Atypical Antipsychotics |
Actual Study Start Date : | November 2008 |
Estimated Primary Completion Date : | December 2025 |
Estimated Study Completion Date : | December 2025 |
Group/Cohort |
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Pregnant women using atypical antipsychotic(s)
Pregnant women who have taken at least one type of atypical antipsychotic at some point during this pregnancy.
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Pregnant women not using atypical antipsychotics
Pregnant women who have not taken an atypical antipsychotic during pregnancy.
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- Rate of major malformations in infants exposed to atypical antipsychotics during the first trimester of pregnancy [ Time Frame: Birth to six months old ]The primary outcome for this study is rates of major malformations in infants exposed in utero to atypical antipsychotics during the first trimester of pregnancy. This data is collected through pediatric medical record review through the first six months of infants' lives.
- Maternal health outcomes [ Time Frame: During pregnancy ]Maternal health outcomes during pregnancy will also be assessed in women taking atypical antipsychotics during pregnancy (for example: weight gain, gestational hypertension, gestational diabetes, preeclampsia)
- Neonatal health outcomes [ Time Frame: Birth to six months old ]Other neonatal health outcomes will also be assessed in infants exposed in utero to atypical antipsychotics (for example: birth weight/length, Apgar scores, NICU admission rates, and any other neonatal complications). Presence of extrapyramidal symptoms from birth to one month old will also be assessed in infants exposed to atypical antipsychotics proximate to delivery.

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Pregnant women
- Age 18-45
- Currently taking or have taken an atypical antipsychotic during pregnancy (or for internal control, women not exposed to atypical antipsychotics)
- Subjects will be willing to participate over the phone
- Subjects will be able to provide informed consent
Exclusion Criteria:
- Women who have completed their pregnancy
- Women who are planning to become pregnant

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 ClinicalTrials.gov identifier (NCT number): NCT01246765
Contact: Heather A Harmon, MPH | 6176435154 | haharmon@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Heather Harmon, MPH 617-643-5154 haharmon@partners.org | |
Principal Investigator: Lee S Cohen, MD |
Principal Investigator: | Lee S Cohen, MD | Massachusetts General Hospital |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Lee S. Cohen, MD, Director for Center of Women's Mental Health, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01246765 |
Other Study ID Numbers: |
2008P-001861 |
First Posted: | November 23, 2010 Key Record Dates |
Last Update Posted: | August 31, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Atypical Antipsychotics and pregnancy Pregnancy Medication use during pregnancy |
Disease Schizophrenia Bipolar Disorder Psychotic Disorders |
Pathologic Processes Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Bipolar and Related Disorders |