National Pregnancy Registry for Psychiatric Medications
ID: NCT01246765
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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.
Read Full Scientific Objectives & Methods
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.
Treatment Arms 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)
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)
Pregnant women who have taken at least one type of ADHD medication at some point during pregnancy. Medications of Special Interest: • Qelbree (viloxazine)
Pregnant women who have taken at least one type of sedative hypnotic medication at some point during pregnancy. Medications of Special Interest: • Dayvigo (lemborexant)
Pregnant women who have taken other psychiatric medications (other than atypical antipsychotics, ADHD medications, antidepressants, or sedative hypnotics) at some point during pregnancy.
- Pregnant women
- Age 18-45
- Subjects will be willing to participate over the phone
- Subjects will be able to provide informed consent
- 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
Primary Outcome Measures
- 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.
The primary outcome for this study is rates of major malformations among infants exposed in-utero to psychiatric medications. A major malformation is defined as a structural abnormality with surgical, medical, or cosmetic importance. Exclusions include (1) minor anomalies; (2) deformations; (3) physiologic features due to prematurity, such as undescended testes; (4) birthmarks; (5) genetic disorders and chromosomal abnormalities; and (6) any finding by prenatal sonography, such as absence of 1 kidney, or at surgery (or autopsy) that was not identified by an examining pediatrician. This data is collected through review of pediatric medical records through the first twelve months of infants' lives.
View Secondary Outcome Measures (20)
- Maternal Gestational Weight Gain — Time Frame: Change from pre-pregnancy to delivery; assessed at 7 months' gestation and 8-12 weeks postpartum.
Maternal gestational weight gain is measured by the change in maternal weight from pre-pregnancy to weight at delivery, recorded in pounds.
- Live Birth — Time Frame: Birth; assessed at 8-12 weeks postpartum.
Did the pregnancy end in a live birth, assessed as a yes/no outcome.
- Spontaneous Abortion (SAB) — Time Frame: Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.
Did a spontaneous abortion (SAB) occur during the pregnancy, assessed as a yes/no outcome.
- Intrauterine Fetal Demise (IUFD) — Time Frame: Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.
Did intrauterine fetal demise (IUFD) occur during the pregnancy, assessed as a yes/no outcome.
- Gestational Age — Time Frame: Birth; assessed at 8-12 weeks postpartum.
The gestational age of the infant at birth, recorded in weeks and days.
- Preterm Delivery — Time Frame: Any time during pregnancy; assessed at 7 months' gestation and 8-12 weeks postpartum.
Was the baby born before 37 weeks gestational age, assessed as a yes/no outcome.
- Birth Weight — Time Frame: Birth; assessed at 8-12 weeks postpartum.
Birth weight of the infant, recorded in grams or lbs and oz
- Delivery Method — Time Frame: Birth; assessed at 8-12 weeks postpartum.
Was birth vaginal or by C-section; if C-section, emergent: yes/no
- Gestational Diabetes — Time Frame: Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.
Gestational diabetes diagnosed during pregnancy, assessed as a yes/no outcome.
- Gestational Hypertension — Time Frame: Any time during pregnancy; assessed at baseline, 7 months' gestation and 8-12 weeks postpartum.
Gestational hypertension diagnosed during pregnancy, assessed as a yes/no outcome.
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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- Cohen LS, Viguera AC, McInerney KA, Freeman MP, Sosinsky AZ, Moustafa D, Marfurt SP, Kwiatkowski MA, Murphy SK, Farrell AM, Chitayat D, Hernandez-Diaz S. Reproductive Safety of Second-Generation Antipsychotics: Current Data From the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. Am J Psychiatry. 2016 Mar 1;173(3):263-70. doi: 10.1176/appi.ajp.2015.15040506. Epub 2015 Oct 6.PubMed ↗
- Swetlik C, Cohen LS, Kobylski LA, Sojka ET, Killenberg PC, Freeman MP, Viguera AC. Effects of Prenatal Exposure to Second-Generation Antipsychotics on Development and Behavior Among Preschool-Aged Children: Preliminary Results From the National Pregnancy Registry for Psychiatric Medications. J Clin Psychiatry. 2024 Mar 13;85(1):23m14965. doi: 10.4088/JCP.23m14965.PubMed ↗
- Szpunar MJ, Freeman MP, Kobylski LA, Rossa ET, Gaccione P, Chitayat D, Viguera AC, Cohen LS. Risk of Major Malformations in Infants After First-Trimester Exposure to Stimulants: Results From the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications. J Clin Psychopharmacol. 2023 Jul-Aug 01;43(4):326-332. doi: 10.1097/JCP.0000000000001702. Epub 2023 May 29.PubMed ↗
- Viguera AC, Freeman MP, Kobylski LA, Rossa ET, Gaccione P, Chitayat D, Hernandez-Diaz S, Cohen LS. Risk of Major Malformations Following First-Trimester Exposure to Olanzapine: Preliminary Data From the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications. J Clin Psychopharmacol. 2023 Mar-Apr 01;43(2):106-112. doi: 10.1097/JCP.0000000000001665.PubMed ↗
- Cohen LS, Church TR, Freeman MP, Gaccione P, Caplin PS, Kobylski LA, Arakelian M, Rossa ET, Chitayat D, Hernandez-Diaz S, Viguera AC. Reproductive Safety of Lurasidone and Quetiapine: Update from the National Pregnancy Registry for Psychiatric Medications. J Womens Health (Larchmt). 2023 Apr;32(4):452-462. doi: 10.1089/jwh.2022.0310. Epub 2023 Jan 30.PubMed ↗
View Official Medical/Scientific Title
National Pregnancy Registry for Psychiatric Medications