Recruiting

Psychiatric Medications

Sponsor:

Massachusetts General Hospital

Code:

NCT01246765

Conditions

Pregnant Women

Psychotropic Drugs

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Study Details

Brief summary:

The National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating the safety of psychiatric medications such as antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics that many people take during pregnancy to treat a wide range of mood, anxiety, executive function, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is limited.

Conditions

Pregnant Women

Psychotropic Drugs

Study ID

NCT01246765

Start date

Nov, 2008

Status verified date

Oct, 2025

Completion date

Dec, 2033

Anticipated

Primary completion date

Dec, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Pregnant women
  • Age 18-45
  • 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
  • Women who are not taking any psychiatric medications and/or have no history of psychiatric illness

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

Atypical Antipsychotic Cohort

Pregnant women who have taken at least one type of atypical antipsychotic at some point during pregnancy.

Medications of Special Interest:

  • Abilify (aripiprazole)
  • Aristada (aripiprazole lauroxil)
  • Aristada Initio (aripiprazole lauroxil)
  • Clozaril (clozapine)
  • Lybalvi (olanzapine and samidorphan)
  • Rexulti (brexpiprazole)
  • Risperdal (risperidone)
  • Seroquel (quetiapine)
  • Symbax (olanzapine-fluoxetine HCL)
  • Zyprexa (olanzapine)

Antidepressant Medications

Pregnant women who have taken at least one type of antidepressant medication at some point during pregnancy.

Medications of Special Interest:

  • Spravato (esketamine)
  • Zulresso (brexanolone)

ADHD Medications

Pregnant women who have taken at least one type of ADHD medication at some point during pregnancy.

Medications of Special Interest:

• Qelbree (viloxazine)

Sedative Hypnotic Medications

Pregnant women who have taken at least one type of sedative hypnotic medication at some point during pregnancy.

Medications of Special Interest:

• Dayvigo (lemborexant)

Other Psychiatric Medications

Pregnant women who have taken other psychiatric medications (other than atypical antipsychotics, ADHD medications, antidepressants, or sedative hypnotics) at some point during pregnancy.

Primary outcome measure

  • Major Malformations in Infants [ Time Frame: Birth up to 1 year; assessed at 8-12 weeks postpartum, assessed through medical records through 1 year of age. ]

Central Contacts and Locations

Central contacts

Bryn Rediger

(617) 724-8020brediger@partners.org

Lee Cohen, MD

(617) 724-8020lcohen2@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Bryn Rediger, BA

(617) 724-8020admin@womensmentalhealth.org

Principal Investigator:

Lee Cohen, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Keywords

  • Pregnancy
  • Medication use during pregnancy
  • Psychiatric medications
  • ADHD
  • Atypical Antipsychotics
  • Antidepressants
  • Sedative Hypnotics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-10-24.