National Pregnancy Registry for Atypical Antipsychotics
Study Details
Study Description
Brief Summary
The purpose of the National Pregnancy Registry for Atypical Antipsychotics is to determine the frequency of birth defects among infants exposed to atypical antipsychotics.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Detailed Description
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Pregnant women using atypical antipsychotic(s) Pregnant women who have taken at least one type of atypical antipsychotic at some point during this pregnancy. |
|
Pregnant women not using atypical antipsychotics Pregnant women who have not taken an atypical antipsychotic during pregnancy. |
Outcome Measures
Primary Outcome Measures
- Rate of major malformations in infants exposed to atypical antipsychotics during the first trimester of pregnancy [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.
Secondary Outcome Measures
- Maternal health outcomes [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 [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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
- Sunovion
- Alkermes, Inc.
- Otsuka America Pharmaceutical
- Teva Pharmaceutical Industries, Ltd.
- Sage Therapeutics
Investigators
- Principal Investigator: Lee S Cohen, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 2008P-001861