National Pregnancy Registry for Atypical Antipsychotics

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
AstraZeneca
Bristol-Myers Squibb
Ortho-McNeil Janssen Scientific Affairs, LLC
Pfizer
Information provided by (Responsible Party):
Lee S. Cohen, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01246765
First received: November 22, 2010
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 15 Months
Official Title: National Pregnancy Registry for Atypical Antipsychotics

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Rate of major malformations in infants exposed to atypical antipsychotics during the first trimester of pregnancy [ Time Frame: Birth to six months old ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: During pregnancy ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 800
Study Start Date: November 2008
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

National Pregnancy Registry—Long 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)
  • Clozaril (clozapine)
  • Geodon (ziprasidone)
  • Invega (paliperidone)
  • Risperdal (risperidone)
  • Seroquel (quetiapine)
  • Zyprexa (olanzapine)
  • Saphris (asenapine)
  • Fanapt (iloperidone)
  • Latuda (lurasidone)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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 an atypical antipsychotic (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246765

Contacts
Contact: Molly A Kwiatkowski, BA 617-724-6989 mkwiatkowski@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Lee S Cohen, MD         
Sponsors and Collaborators
Massachusetts General Hospital
AstraZeneca
Bristol-Myers Squibb
Ortho-McNeil Janssen Scientific Affairs, LLC
Pfizer
Investigators
Principal Investigator: Lee S Cohen, MD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Lee S. Cohen, MD, Director for Center of Women's Mental Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01246765     History of Changes
Other Study ID Numbers: 2008P-001861
Study First Received: November 22, 2010
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Atypical Antipsychotics and pregnancy
Pregnancy
Medication use during pregnancy

Additional relevant MeSH terms:
Depression
Schizophrenia
Bipolar Disorder
Disease
Psychotic Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Affective Disorders, Psychotic
Mood Disorders
Pathologic Processes
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 29, 2014