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NCT01246765 · ClinicalTrials.gov registry record
National Pregnancy Registry for Psychiatric Medications
A clinical trial of Pregnant Women and Psychotropic Drugs, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- 5,000
- Enrollment target
- 1
- Study location
NCT01246765: Recruiting study of Pregnant Women and Psychotropic Drugs, sponsored by Massachusetts General Hospital.
NCT01246765 is a study of Pregnant Women and Psychotropic Drugs that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 5,000 participants, above the 169-participant average among 5 other Pregnant Women trials with a reported enrollment target (2859% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01246765, a study of Pregnant Women and Psychotropic Drugs, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- 5,000 participants
- Enrollment target
- 1
- Study location
Study Summary
The National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating the safety of psychiatric medications such as antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics that many people take during pregnancy to treat a wide range of mood, anxiety, executive function, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is limited.
Primary Outcome
The primary outcome for this study is rates of major malformations among infants exposed in-utero to psychiatric medications. A major malformation is defined as a structural abnormality with surgical, medical, or cosmetic importance. Exclusions include (1) minor anomalies; (2) deformations; (3) physiologic features due to prematurity, such as undescended testes; (4) birthmarks; (5) genetic disorders and chromosomal abnormalities; and (6) any finding by prenatal sonography, such as absence of 1 k
Conditions Studied
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,000 participants |
| Start Date | 2008-11 |
| Est. Completion | 2033-12 |
What NCT01246765 shows while recruiting
NCT01246765 is an observational study that tracks outcomes without assigning an intervention. Its 5,000 participants enrollment target places it among the larger protocols in the corpus, above the 169-participant average among 5 other Pregnant Women trials with a reported enrollment target (2859% higher).
The record links to 2 conditions, with Pregnant Women appearing as the primary indexed condition, and to 0 interventions.
NCT01246765 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01246765 about?
NCT01246765 is a clinical study titled "National Pregnancy Registry for Psychiatric Medications". The National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating the safety of psychiatric medications such as antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics that many people take during pregnancy to treat a wide range of mood, anxiety, execu...
What is the current status of trial NCT01246765?
This trial is currently recruiting. The enrollment target is 5,000 participants. The study started on 2008-11. Estimated completion is 2033-12.
What conditions does trial NCT01246765 study?
This clinical trial studies the following conditions: Pregnant Women, Psychotropic Drugs.
Who is sponsoring clinical trial NCT01246765?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01246765 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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