National Pregnancy Registry for Atypical Antipsychotics

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT01246765
Collaborator
Sunovion (Industry), Alkermes, Inc. (Industry), Otsuka America Pharmaceutical (Industry), Teva Pharmaceutical Industries, Ltd. (Industry), Sage Therapeutics (Industry)
2,500
1
205
12.2

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.

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
2500 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
National Pregnancy Registry for Atypical Antipsychotics
Actual Study Start Date :
Nov 1, 2008
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

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

  1. 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

  1. 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)

  2. 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

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

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:
Nov 23, 2010
Last Update Posted:
Aug 31, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Lee S. Cohen, MD, Director for Center of Women's Mental Health, Massachusetts General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 31, 2021