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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: Recruiting study of Pregnancy and Antipsychotics, sponsored by Icahn School of Medicine at Mount Sinai.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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), screen
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 |
What NCT06049953 shows while recruiting
NCT06049953 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Pregnancy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06049953's enrollment target sits among peer trials
200 84th of 191 higher than 103 of 191 other Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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