Mood DisorderNCT00001177
Study of Premenstrual Syndrome and Premenstrual Dysphoria
An observational study of Mood Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The purpose of this study is to identify and describe the symptoms of premenstrual syndrome (PMS). Women who experience PMS symptoms will complete clinical interviews, self-rating scales, and evaluations of mood and endocrine function. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Mood Disorder
- How many people
- 1,569 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 1984to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: This study will enroll up to 700 females with menstrually-related mood or behavioral difficulties and 900 healthy volunteers.
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: The Evaluation of Women With Menstrually Regulated Mood and Behavioral Disorders
The purpose of this study is to identify and describe the symptoms of premenstrual syndrome (PMS).
Women who experience PMS symptoms will complete clinical interviews, self-rating scales, and evaluations of mood and endocrine function. A subgroup of women with severe PMS (Premenstrual Dysphoric Disorder or PMDD) will be offered additional research studies that focus on: 1) identifying the endocrine changes that may be responsible for changes in mood and behavior during the premenstrual period, 2) evaluating treatments for PMS symptoms, and/or 3) identifying genetic factors in women with and without PMS. Women with recurrent brief depression will also be recruited to serve as a comparison group.
Read the detailed description
The purpose of this screening protocol is to identify a population of women who experience menstrually-related mood or behavior difficulties and to describe the symptoms in this group and their relationship to the menses. This will be accomplished by means of clinical interviews, self-rating scales, and periodic evaluation of mood and endocrine function. We further wish to identify and recruit a subgroup of women with menstrually-related mood disorder for participation in specific neuroendocrine/neurophysiologic studies (companion protocols) in an attempt to identify endocrinologic or physiologic measures that might: 1) be associated with the discrete changes in mood and behavior; 2) distinguish this group from a group of age-matched controls; 3) allow for further subgroup definition on the basis of predicted response to pharmacological intervention. Finally, we wish to identify a group of women with recurrent brief depression, who will serve as an additional control group for the patients with menstrual cycle-related mood disorders.
- Conditions
- Mood Disorder
- Keywords
- Cognition, Neuroendocrine, PMS Premenstrual Syndrome, MRMD Menstrually Related Mood Disorder, Menstrual
- Medical subject headings
- Mood Disorders, Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | healthy females | |
| patients | females with menstrually-related mood or behavioral difficulties |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized cross-sectional rating scales (Beck Depression Inventory, Hamilton Depression and Anxiety Scales, and the Rating Scale for Premenstrual Tension Syndrome), symptom rating scales completed daily, and plasma hormone measures (including...
Standardized cross-sectional rating scales (Beck Depression Inventory, Hamilton Depression and Anxiety Scales, and the Rating Scale for Premenstrual Tension Syndrome), symptom rating scales completed daily, and plasma hormone measures (including neurosteroid levels).
Measured: Ongoing
Secondary outcomes (1)
Plasma ACTH and cortisol response, selected variants in genomic profile (e.g., SNPs) and genome/exome sequencing, metabolomic profiles, and the results of the SCID interviews (e.g. past history of postpartum depression).
Plasma ACTH and cortisol response, selected variants in genomic profile (e.g., SNPs) and genome/exome sequencing, metabolomic profiles, and the results of the SCID interviews (e.g. past history of postpartum depression).
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start9 Mar 1984
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mood DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,569 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter J Schmidt, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001177
- Sponsor's protocol ID
- 810126
- Other IDs
- 81-M-0126
- Status last verified
- 6 Apr 2026
- First submitted
- 3 Nov 1999
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with dbGaP, BTRIS and NIMH Data Archive as determined by the Principal Investigator.
Publications
Rubinow DR. The premenstrual syndrome. New views. JAMA. 1992 Oct 14;268(14):1908-12. No abstract available.
PubMed 1404717Schmidt PJ, Nieman LK, Danaceau MA, Adams LF, Rubinow DR. Differential behavioral effects of gonadal steroids in women with and in those without premenstrual syndrome. N Engl J Med. 1998 Jan 22;338(4):209-16. doi: 10.1056/NEJM199801223380401.
PubMed 9435325Bancroft J. The premenstrual syndrome--a reappraisal of the concept and the evidence. Psychol Med. 1993;Suppl 24:1-47. doi: 10.1017/s0264180100001272.
PubMed 7906420Zou CX, Guerrieri GM, Martinez PE, Li X, Ben Dor R, Bovell RTM, Naredo Rojas JM, McCluggage P, Kress N, Neiman LK, Rubinow DR, Schmidt PJ. Cortisol and ACTH response to Dex/CRH testing and 24-hour urine free cortisol levels in women with and without premenstrual dysphoric disorder. Psychoneuroendocrinology. 2025 Feb;172:107250. doi: 10.1016/j.psyneuen.2024.107250. Epub 2024 Nov 30.
PubMed 39644712
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Women With Menstrually Regulated Mood and Behavioral Disorders
- ClinicalTrials.gov ID
- NCT00001177
- Acronym / sponsor ID
- 810126
- Conditions
- Mood Disorder
- Keywords
- Cognition, Neuroendocrine, PMS Premenstrual Syndrome, MRMD Menstrually Related Mood Disorder, Menstrual
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,569 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 9 Mar 1984 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify and describe the symptoms of premenstrual syndrome (PMS).
Women who experience PMS symptoms will complete clinical interviews, self-rating scales, and evaluations of mood and endocrine function. A subgroup of women with severe PMS (Premenstrual Dysphoric Disorder or PMDD) will be offered additional research studies that focus on: 1) identifying the endocrine changes that may be responsible for changes in mood and behavior during the premenstrual period, 2) evaluating treatments for PMS symptoms, and/or 3) identifying genetic factors in women with and without PMS. Women with recurrent brief depression will also be recruited to serve as a comparison group.
Detailed description
The purpose of this screening protocol is to identify a population of women who experience menstrually-related mood or behavior difficulties and to describe the symptoms in this group and their relationship to the menses. This will be accomplished by means of clinical interviews, self-rating scales, and periodic evaluation of mood and endocrine function. We further wish to identify and recruit a subgroup of women with menstrually-related mood disorder for participation in specific neuroendocrine/neurophysiologic studies (companion protocols) in an attempt to identify endocrinologic or physiologic measures that might: 1) be associated with the discrete changes in mood and behavior; 2) distinguish this group from a group of age-matched controls; 3) allow for further subgroup definition on the basis of predicted response to pharmacological intervention. Finally, we wish to identify a group of women with recurrent brief depression, who will serve as an additional control group for the patients with menstrual cycle-related mood disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | –healthy females |
| patients | – | –females with menstrually-related mood or behavioral difficulties |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will enroll up to 700 females with menstrually-related mood or behavioral difficulties and 900 healthy volunteers.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Standardized cross-sectional rating scales (Beck Depression Inventory, Hamilton Depression and Anxiety Scales, and the Rating Scale for Premenstrual Tension Syndrome), symptom rating scales completed daily, and plasma hormone measures (including...
Time frame: Ongoing
Standardized cross-sectional rating scales (Beck Depression Inventory, Hamilton Depression and Anxiety Scales, and the Rating Scale for Premenstrual Tension Syndrome), symptom rating scales completed daily, and plasma hormone measures (including neurosteroid levels).
1 secondary outcome
Plasma ACTH and cortisol response, selected variants in genomic profile (e.g., SNPs) and genome/exome sequencing, metabolomic profiles, and the results of the SCID interviews (e.g. past history of postpartum depression).
Time frame: ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 1404717Rubinow DR. The premenstrual syndrome. New views. JAMA. 1992 Oct 14;268(14):1908-12. No abstract available.
- Background: PubMed 9435325Schmidt PJ, Nieman LK, Danaceau MA, Adams LF, Rubinow DR. Differential behavioral effects of gonadal steroids in women with and in those without premenstrual syndrome. N Engl J Med. 1998 Jan 22;338(4):209-16. doi: 10.1056/NEJM199801223380401.
- Background: PubMed 7906420Bancroft J. The premenstrual syndrome--a reappraisal of the concept and the evidence. Psychol Med. 1993;Suppl 24:1-47. doi: 10.1017/s0264180100001272.
- Derived from this study: PubMed 39644712Zou CX, Guerrieri GM, Martinez PE, Li X, Ben Dor R, Bovell RTM, Naredo Rojas JM, McCluggage P, Kress N, Neiman LK, Rubinow DR, Schmidt PJ. Cortisol and ACTH response to Dex/CRH testing and 24-hour urine free cortisol levels in women with and without premenstrual dysphoric disorder. Psychoneuroendocrinology. 2025 Feb;172:107250. doi: 10.1016/j.psyneuen.2024.107250. Epub 2024 Nov 30.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be shared with dbGaP, BTRIS and NIMH Data Archive as determined by the Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J Schmidt, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mood Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized cross-sectional rating scales (Beck Depression Inventory, Hamilton Depression and Anxiety Scales, and the Rating Scale for Premenstrual Tension Syndrome), symptom rating scales completed daily, and plasma hormone measures (including... (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001177, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.