Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
800

Summary

Conditions
  • Bipolar Disorder
  • Depression
  • Schizoaffective Disorder
  • Schizophrenia
  • Use of Atypical Antipsychotics During Pregnancy
Design
Observational Model: Case-ControlTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 45 years
Gender
Only males

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 ...

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)

Tracking Information

NCT #
NCT01246765
Collaborators
  • Sunovion
  • Alkermes, Inc.
  • Otsuka America Pharmaceutical
  • Teva Pharmaceutical Industries, Ltd.
  • Sage Therapeutics
Investigators
Principal Investigator: Lee S Cohen, MD Massachusetts General Hospital