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Hormone rollercoaster mimics postpartum depression in lab

NCT ID NCT00001481

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study enrolled 74 women with a history of postpartum depression to see if the sudden drop in hormones after childbirth causes mood symptoms. Researchers used hormone medications to simulate pregnancy and delivery in a controlled setting. The goal was to understand whether it's the withdrawal of hormones or the prolonged exposure that leads to depression.

What this could mean

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

Active substance
estradiol, progesterone, leuprolide acetate
What this could lead to
If successful, this could help identify why some women develop postpartum depression and point toward prevention strategies.
What could go wrong
This is a small, early-phase study that creates a temporary hormone state, not a treatment trial. Results may not apply to real-world postpartum depression.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

74 people

The number who actually took part.

Started

Apr 1996

Finished

Oct 2024

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: A. Group 1: Women with a history of postpartum depression: 1. A history of Diagnostic and Statistical Manual (DSM)-IV major depression or hypomanic/manic episode that occurred within three months of childbirth (as determined by a Structured Clinical Interview for the DSM (SCID) interview)); 2. has been well for a minimum of one year; 3. a regular menstrual cycle for at least three months; 4. age 18-50; 5. not pregnant, not lactating and in good medical health; 6. medication free (including birth control pills); 7. no history of puerperal suicide attempts or psychotic episodes requiring hospitalization. B. Group 2: Women with a history of Major Depressive Disorder 1. A history of DSM-IV major depression episode(s) occurring outside of pregnancy and not within three months postpartum; 2. has been well for a minimum of one year; 3. a regular menstrual cycle for at least three months; 4. age 18-50; 5. not pregnant, not lactating and in good medical health; 6. medication free (including birth control pills); 7. no history of suicide attempts or psychotic episodes requiring hospitalization. C. Group 3: Normal Controls 1\) Controls will meet all criteria specified except they must not have any past or present Axis I diagnosis or evidence of menstrual related mood disorders. EXCLUSION CRITERIA: Patients will not be permitted to enter this protocol if they have important clinical or laboratory abnormalities including any history of the following: * endometriosis; * undiagnosed enlargement of the ovaries; * liver disease; * breast cancer; * a history of blood clots in the legs or lungs; * undiagnosed vaginal bleeding; * porphyria; * diabetes mellitus; * malignant melanoma; * gallbladder or pancreatic disease; * heart or kidney disease; * cerebrovascular disease (stroke); * cigarette smoking; * a history of suicide attempts or psychotic episodes requiring hospitalization; * recurrent migraine headaches; * pregnancy (patients will be warned not to become pregnant during the study and will be advised to employ barrier contraceptive methods; * pregnancy-related medical conditions such as hyperemesis gravidarum, pretoxemia and toxemia, deep vein thrombosis (DVT) and bleeding diathesis; * Any woman with a first degree relative (immediate family) with premenopausal breast cancer or breast cancer presenting in both breasts or any woman who has multiple family members (greater than three relatives) with postmenopausal breast cancer will also be excluded from participating in this protocol; * Any woman meeting the Stages of Reproductive Aging Workshop Criteria (STRAW) for the perimenopause will be excluded from participation. Specifically, we will exclude any woman with an elevated plasma follicle stimulating hormone (FSH) level (greater than or equal to 14 IU/L) and with menstrual cycle variability of \> 7 days different from their normal cycle length; * Subjects who are unable to provide informed consent; * National Institute of Mental Health (NIMH) employees and staff and their immediate family members will be excluded from the study per NIMH policy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

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Other studies related to the condition(s) this trial covers.