National Pregnancy Registry for Psychiatric Medications

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT01246765
Status
Recruiting
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Conditions

  • Pregnant Women
  • Psychotropic Drugs

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Nov 30, 2008
Status verified
Oct 2025
Primary completion
Dec 31, 2033
Completion
Dec 31, 2033

Study Design

Enrollment
5,000 participants (estimated)

Arms

  • Arm: 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)
  • Arm: 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)
  • Arm: 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)
  • Arm: 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)
  • Arm: 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

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Bryn Rediger, BA
[email protected]
(617) 724-8020
Lee Cohen, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MA

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