National Pregnancy Registry for Atypical Antipsychotics

  • STATUS
    Recruiting
  • End date
    Dec 24, 2023
  • participants needed
    2500
  • sponsor
    Massachusetts General Hospital
Updated on 24 January 2021
antipsychotics
atypical antipsychotic
typical antipsychotic

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.

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)

Details
Condition Psychosis, Endogenous depression, Depression, Bipolar Disorder, Schizophrenia, Depression (Major/Severe), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Depression (Treatment-Resistant), Schizophrenia and Schizoaffective Disorders, Use of Atypical Antipsychotics During Pregnancy, Depressed, Bipolar Disorders (Pediatric), Schizophrenia and Schizoaffective Disorders (Pediatric), Manic Disorders, depressive disorder, schizophrenia disorders, schizoaffective disorder, depressed mood, miserable, depressive disorders
Clinical Study IdentifierNCT01246765
SponsorMassachusetts General Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 45 yrs?
Are you female?
Do you have any of these conditions: Manic Disorders or Depression (Adolescent) or Schizophrenia or Depression (Treatment-Resistant) or Endogenous depression or Depression (Pediatric) or ...?
Do you have any of these conditions: Bipolar Disorder or depressed mood or Endogenous depression or Depression (Treatment-Resistant) or miserable or Schizophrenia or Schizophrenia and Sch...?
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
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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