Clinical trial
Developmental Effects of Antenatal Exposure to Antipsychotics
Name
STUDY 23-00239
Description
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.
Trial arms
Trial start
2023-09-29
Estimated PCD
2027-08-01
Trial end
2027-08-01
Status
Recruiting
Treatment
Antipsychotics
Antipsychotic medications are widely prescribed for severe mental illness such as affective and non-affective psychosis, mood stabilization, and augmentation of unipolar depression.
Arms:
Antipsychotic medication
Non-antipsychotic medication
Psychotropic medications are typically prescribed to manage symptoms of anxiety, depression, psychological distress, and/or insomnia.
Arms:
Non-antipsychotic medication
Other names:
Antidepressants, Benzodiazepines
No Medication
Non-psychotropic medications
Arms:
No medication
Size
200
Primary endpoint
Mini-International Neuropsychiatric Interview
through study completion, an average of 6 months postpartum
Finnegan Neonatal Abstinence Scoring System
24 hours postnatal
Ratio of auditory evoked potentials as measured by EEG
6 months postnatal
Eligibility criteria
Inclusion Criteria:
* Pregnant
* Severe mental illness, including:
* Psychotic disorder (affective and nonaffective)
* Bipolar disorder
* History of psychiatric hospitalization, regardless of diagnosis
* Able to complete study interviews and measures in English, Dutch, or Spanish
Exclusion Criteria:
* Active substance use disorder in pregnancy
* Insufficiently high-functioning to provide full informed consent and/or participate in study procedures
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Paired whole blood and plasma samples obtained from the mother and from the umbilical cord at delivery will be stored.'}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-11-13
1 organization
1 product
1 drug
2 indications
Organization
Icahn School of Medicine at Mount SinaiDrug
AntipsychoticsIndication
Antipsychotic agentsIndication
PregnancyProduct
Non-antipsychotic medication