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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 : March 16, 2020
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

Tracking Information
First Submitted Date November 22, 2010
First Posted Date November 23, 2010
Last Update Posted Date March 16, 2020
Actual Study Start Date November 2008
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2014)
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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: April 15, 2014)
  • 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title National Pregnancy Registry for Atypical Antipsychotics
Official Title National Pregnancy Registry for Atypical Antipsychotics
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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 15 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pregnant women from across the United States will be enrolled in this registry.
Condition
  • Use of Atypical Antipsychotics During Pregnancy
  • Schizophrenia
  • Bipolar Disorder
  • Depression
  • Schizoaffective Disorder
Intervention Not Provided
Study 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 7, 2020)
2500
Original Estimated Enrollment
 (submitted: November 22, 2010)
800
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Phoebe Caplin, BA 1-866-961-2388 registry@partners.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01246765
Other Study ID Numbers 2008P-001861
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Lee S. Cohen, MD, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators
  • Sunovion
  • Alkermes, Inc.
  • Otsuka America Pharmaceutical
  • Teva Pharmaceutical Industries, Ltd.
  • Sage Therapeutics
Investigators
Principal Investigator: Lee S Cohen, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2020