Health TrialsbyHealthPanel

Maternal And Infant Antipsychotic Study

ConditionsAntipsychoticsPregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

The goal of this observational study is to learn about maternal psychiatric course and infant development in pregnant individuals with severe mental illness, comparing those treated with antipsychotics to those treated with other medications or without medication. The main questions it aims to answer are:

1. Is risk of psychiatric relapse different among individuals who take antipsychotic medication, other medication, or no medication? 2. Are pregnancy and neonatal health outcomes different among individuals who take antipsychotic medication, other medication, or no medication? 3. Do infant behavior and neurodevelopment differ among babies who were exposed to antipsychotic medication, other medication, or no medication in utero? Participants will

* complete a psychiatric interview and questionnaires while pregnant; * donate blood from the mother and from the umbilical cord at delivery * have their babies participate in infant behavior evaluations and an EEG procedure.

Researchers will compare these outcomes among individuals who were treated either with antipsychotic medication, with psychotropic medications of other classes, and with no medication, to see if psychiatric benefits for the mother and health outcomes for mother and child differ among these three types of treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant

Psychotic disorder (affective and nonaffective)

Bipolar disorder

History of psychiatric hospitalization, regardless of diagnosis

Disqualifiers

Active substance use disorder in pregnancy

Insufficiently high-functioning to provide full informed consent and/or participate in study procedures

Trial population

Pregnant women with severe mental illness as defined in Eligibility Criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Antipsychotics

    Drug

    Antipsychotic medications are widely prescribed for severe mental illness such as affective and non-affective psychosis, mood stabilization, and augmentation of unipolar depression.

  • Non-antipsychotic medication

    Drug

    Psychotropic medications are typically prescribed to manage symptoms of anxiety, depression, psychological distress, and/or insomnia.

  • No Medication

    Other intervention

    Non-psychotropic medications

Treatment groups

74 Participants
are divided into 3 treatment groups
Group A: Antipsychotic medication1 intervention
Group B: Non-antipsychotic medication1 intervention
Group C: No medication1 intervention

Trial outcomes

Primary outcomes

1

Mini-International Neuropsychiatric Interview

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.

Time frame
through study completion, an average of 6 months postpartum
2

Finnegan Neonatal Abstinence Scoring System

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.

Time frame
24 hours postnatal
3

Ratio of auditory evoked potentials as measured by EEG

Electrical activity of brain cells in response to a sound stimulus, measured noninvasively on the outside of the scalp by electroencephalography

Time frame
6 months postnatal

Secondary outcomes

1

Maternal weight gain

Total pregnancy weight gain

Time frame
through delivery, approximately 40 weeks post conception
2

Oral glucose tolerance test score

A glucose screening test is a routine test during pregnancy that checks a pregnant woman's blood glucose (sugar) level. Score on oral glucose tolerance test will be recorded.

Time frame
at 24 weeks
3

Fetal body size

Fetal ultrasound-based and infant anthropometric measurements

Time frame
at 20 weeks
4

Fetal weight

Time frame
at 20 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Erasmus Medical Center

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov
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