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NCT06049953 · ClinicalTrials.gov registry record
Maternal And Infant Antipsychotic Study
A clinical trial of Pregnancy and Antipsychotics, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT06049953 is a study of Pregnancy and Antipsychotics that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 200 participants, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06049953, a study of Pregnancy and Antipsychotics, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG Antipsychotics
- DRUG Non-antipsychotic medication
- OTHER No Medication
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-09-29 |
| Est. Completion | 2027-12-01 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06049953
The ClinicalTrials.gov registry entry for NCT06049953 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (77% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pregnancy appearing as the primary indexed condition, and to 3 interventions - of which Antipsychotics is the first listed.
NCT06049953 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06049953 about?
NCT06049953 is a clinical study titled "Maternal And Infant Antipsychotic Study". 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 answe...
What is the current status of trial NCT06049953?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2023-09-29. Estimated completion is 2027-12-01.
What conditions does trial NCT06049953 study?
This clinical trial studies the following conditions: Pregnancy, Antipsychotics.
What interventions are being tested in trial NCT06049953?
The interventions under investigation include: Antipsychotics (DRUG), Non-antipsychotic medication (DRUG), No Medication (OTHER).
Who is sponsoring clinical trial NCT06049953?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06049953 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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