RECRUITING

Study of Premenstrual Syndrome and Premenstrual Dysphoria

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Evaluation of Women With Menstrually Regulated Mood and Behavioral Disorders

Quick Facts

Study Start:1984-03-09
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00001177

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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;
  2. * 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;
  3. * age 18 to 50;
  4. * not pregnant and in good medical health;
  5. * regular menses.
  6. * dysphoric mood or loss of interest or pleasure;
  7. * duration less than two weeks;
  8. * 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;
  9. * impairment in usual occupational activities;
  10. * at least one-two episodes per month over one year.
  11. * Subjects should have no general medical illness that is primary (i.e., appears to be causing the mood disorder);
  12. * 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;
  13. * 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).
  14. * Pregnant or lactating women
  15. * Subjects who are unable to provide informed consent
  16. * NIMH employees/staff and their immediate family members will be excluded from the study per NIMH policy.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Peter J Schmidt, M.D.
CONTACT
(301) 496-6120
peterschmidt@mail.nih.gov

Principal Investigator

Peter J Schmidt, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Mental Health (NIMH)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Mental Health (NIMH)

  • Peter J Schmidt, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Mental Health (NIMH)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date1984-03-09
Study Completion DateN/A

Study Record Updates

Study Start Date1984-03-09
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

  • Cognition
  • Neuroendocrine
  • PMS Premenstrual Syndrome
  • MRMD Menstrually Related Mood Disorder
  • Menstrual

Additional Relevant MeSH Terms

  • Mood Disorder