Inside the mind: what really happens during PMS?
NCT ID NCT00001177
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 11 times
Summary
This completed study from the National Institute of Mental Health looked at over 1,500 women to better understand the symptoms of premenstrual syndrome (PMS) and a severe form called PMDD. Researchers used interviews, rating scales, and hormone tests to track mood and behavior changes. Some women also joined extra studies on possible causes, treatments, and genetic links.
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 research could help doctors better understand and diagnose PMS and PMDD, leading to improved treatments in the future.
- What could go wrong
- This is an observational study, not a treatment trial. It aims to gather information, so there is no direct benefit for participants. Results may not lead to new therapies.
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
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1,569 people
The number who actually took part.
- Started
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Mar 1984
- Lead sponsor
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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.
Who is studied
This study will enroll up to 700 females with menstrually-related mood or behavioral difficulties and 900 healthy volunteers.
- Ages
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18 to 50 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: The subjects of this study will be women who meet the following criteria: * history within the last two years of at least six months with menstrually-related mood or behavioral disturbances of at least moderate severity - that is, disturbances that are distinct in appearance and associated with a notable degree of subjective distress; * a 30% increase in mean negative mood ratings (relative to the range of the scale employed) in the premenstrual week compared with the week following the end of menses in at least two of three cycles; * age 18 to 50; * not pregnant and in good medical health; * regular menses. For subjects with recurrent brief depression: * dysphoric mood or loss of interest or pleasure; * duration less than two weeks; * four of the following symptoms: poor appetite or significant weight loss (when not dieting) or increased appetite or significant weight gain; insomnia or hypersomnia; psychomotor agitation or retardation; loss of interest or pleasure in usual activities, or decrease in sexual drive; loss of energy; fatigue; feelings of worthlessness, self-reproach, or excessive or inappropriate guilt; diminished ability to think or concentrate, slowed thinking, or indecisiveness; * impairment in usual occupational activities; * at least one-two episodes per month over one year. Age-matched women without mood and behavioral disorders will be recruited. EXCLUSION CRITERIA for all study participants: * Subjects should have no general medical illness that is primary (i.e., appears to be causing the mood disorder); * Current antidepressant therapy (since this is a screening protocol for subsequent treatment and physiologic evaluation studies in which participants must be untreated). Antidepressants will not be withheld from participants who need or want them; * Current alcohol or substance use or dependence (excluding nicotine) of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment, but not including self-help groups). * Pregnant or lactating women * Subjects who are unable to provide informed consent * NIMH employees/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
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Online group therapy helps workers with depression get back on the job