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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
Sponsor:
Collaborators:
Sunovion
Alkermes, Inc.
Otsuka America Pharmaceutical
Teva Pharmaceutical Industries, Ltd.
Sage Therapeutics
Information provided by (Responsible Party):
Lee S. Cohen, MD, Massachusetts General Hospital

Study Description
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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
Use of Atypical Antipsychotics During Pregnancy Schizophrenia Bipolar Disorder Depression Schizoaffective Disorder

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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.


Eligibility Criteria
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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
Study Population
Pregnant women from across the United States will be enrolled in this registry.
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
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Information from the National Library of Medicine

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


Contacts
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Contact: Heather A Harmon, MPH 6176435154 haharmon@partners.org

Locations
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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         
Sponsors and Collaborators
Massachusetts General Hospital
Sunovion
Alkermes, Inc.
Otsuka America Pharmaceutical
Teva Pharmaceutical Industries, Ltd.
Sage Therapeutics
Investigators
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Principal Investigator: Lee S Cohen, MD Massachusetts General Hospital
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Lee S. Cohen, MD, Massachusetts General Hospital:
Atypical Antipsychotics and pregnancy
Pregnancy
Medication use during pregnancy
Additional relevant MeSH terms:
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Disease
Schizophrenia
Bipolar Disorder
Psychotic Disorders
 Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders