National Pregnancy Registry for Psychiatric Medications

Last updated: November 8, 2023
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Tourette's Syndrome

Schizophrenia And Schizoaffective Disorders (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01246765
2008P-001861
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 ofpsychiatric illness

Study Design

Total Participants: 5000
Study Start date:
November 01, 2008
Estimated Completion Date:
December 31, 2033

Study Description

The overarching objectives of the National Pregnancy Registry for Psychiatric Medications are twofold: to assess risk for malformations among infants exposed to specific psychiatric medications and to assess neonatal outcomes associated with prenatal exposure to such medication. Specifically, the Registry will allow us to prospectively determine whether exposure to psychiatric medication is associated with any increased risk for major malformations above the baseline risk noted in the general population. This will be achieved by careful systematic documentation of medication exposure during pregnancy, as well as other relevant exposures often not included in small case series or published reviews of drug safety derived from large administrative databases.

Although psychiatric medications are widely used by reproductive age women, reliable data regarding the reproductive safety of many of these compounds is limited. As a result, clinicians often lack sufficient evidence to evaluate the risks and benefits of using medications to treat psychiatric disorders during pregnancy. The National Pregnancy Registry for Psychiatric Medications is one of the first, and largest, hospital-based pregnancy registries which will systematically and prospectively monitor pregnancy outcomes after exposure to psychiatric medications, including antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics.

Primary Aim:

To prospectively evaluate rates of congenital malformations among infants exposed in-utero to psychiatric medications.

Secondary Aims:

  1. To evaluate neonatal outcomes of infants with prenatal exposure to specific psychiatric medications alone or in combination with other psychotropics.

  2. To evaluate maternal health outcomes associated with use of psychiatric medications during pregnancy.

  3. To evaluate neurobehavioral development of children (1 month and older) with prenatal exposure to psychiatric medications.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.