Maternal And Infant Antipsychotic Study
This observational study aims to understand how antipsychotic medications, other medications, or no medication affect pregnant individuals with severe mental illness and their babies. Researchers want to see if taking antipsychotics during pregnancy changes the risk of mental health relapse for the mother, affects pregnancy and newborn health, or impacts the baby's behavior and brain development. You may be eligible if you are pregnant, have a severe mental illness like a psychotic disorder or bipolar disorder, or a history of psychiatric hospitalization. The study will follow mothers through an average of 6 months after birth to measure mental health, newborn health at 24 hours after birth, and infant brain activity at 6 months after birth.
- Study design
- This is an observational study with a planned enrollment of 74 pregnant women. It compares those taking antipsychotics, other psychotropic medications, or no medication.
- What's involved
- You would participate in study interviews and measures, which are conducted through study completion, an average of 6 months postpartum.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed through study completion, an average of 6 months postpartum, with specific measurements at 24 hours and 6 months postnatal.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Maternal And Infant Antipsychotic Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Thalia Robakis, MD, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Mini-International Neuropsychiatric Interviewthrough study completion, an average of 6 months postpartum
In the DSM-5 Mini-International Neuropsychiatric Interview (M.I.N.I.) researchers will conduct modules for major depressive episode, (hypo)manic episode, and psychotic disorders. A clinical structured interview with very precise questions about psychological problems will require a 'yes' or 'no' answer. The M.I.N.I. is divided into modules identified by letters, each corresponding to a diagnostic category. At the beginning of each diagnostic module (except for psychotic disorders module), screening questions(s) corresponding to the main criteria of the disorder are presented in a gray box. At the end of each module, diagnostic box(es) permit the clinician to indicate whether diagnostic criteria are met.
- Finnegan Neonatal Abstinence Scoring System24 hours postnatal
Symptoms of poor neonatal adaptation, as assessed by Finnegan scale at 24 hours of life. Finnegan Neonatal Abstinence Scoring System (NAS) is an observer-rated scale documenting signs of neonatal adaptation. The individual NAS symptoms are weighted (numerically scoring 1-5) depending on the symptom, and the severity of the symptom expressed. The total score ranges from 0 to 43. Infants scoring an 8 or greater are recommended to receive pharmacologic therapy.
- Ratio of auditory evoked potentials as measured by EEG6 months postnatal
Electrical activity of brain cells in response to a sound stimulus, measured noninvasively on the outside of the scalp by electroencephalography