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New registry aims to uncover safety of psychiatric meds in pregnancy

NCT ID NCT01246765

Knowledge-focused Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This registry enrolls 5,000 pregnant women aged 18-45 who take psychiatric medications like antidepressants or ADHD drugs. Researchers track infant health for one year after birth to see if these medications increase the risk of major birth defects. The goal is to provide better safety data for a group where information is currently limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this registry could provide clearer safety information about psychiatric medication use during pregnancy, helping doctors and patients make informed decisions.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may take years and could still leave unanswered questions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2008

Expected to finish

Dec 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pregnant women from across the United States will be enrolled in this registry.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pregnant women * Age 18-45 * Subjects will be willing to participate over the phone * Subjects will be able to provide informed consent Exclusion Criteria: * Women who have completed their pregnancy * Women who are planning to become pregnant * Women who are not taking any psychiatric medications and/or have no history of psychiatric illness

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pregnant women Psychotropic drugs

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

    Contact Email: •••••@•••••

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