National Pregnancy Registry for Psychiatric Medications

Mass General Brigham

Status: Enrolling

Conditions: Psychotropic Drugs; Pregnant Women

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01246765

2008P-001861

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

5,000 participants in 5 patient groups

Atypical Antipsychotic Cohort

Description:

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

Description:

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

Description:

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

Description:

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

Description:

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