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Home > "S" Clinical Trials Conditions > Study of Menstrually-Regulated Mood and Behavioral Disorder  Study of Menstrually-Regulated Mood and Behavioral Disorder
Study of Menstrually-Regulated Mood and Behavioral Disorder
For Condition: Mental Disorder,Mood Disorder
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA: The subjects of this study will be women who meet the following 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 distant 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 18-50; 4) not pregnant and in good medical health; 5) regular menses. EXCLUSION CRITERIA: Subjects who do not meet the criteria listed above but who do not meet diagnosis criteria for recurrent brief depression will also be studied. The criteria for recurrent brief depression include the following: 1) dysphoric mood or loss of increase or pleasure; 2) duration less than two weeks; 3) four of the following symptoms: poor appetite weight gain; insomnia or hypersomnia; psychomotor agitation or retardation; loss of interest or pleasure in usual activities, or decrease in sexual desire; loss of energy; fatigue; feelings of worthlessness, self-reproach, or excessive or inappropriate guilt; diminished ability to think or concentrate, slowed thinking, or indecisiveness; 4) impairment in usual occupational activities; 5) at least one-two episodes per month over one year.
Total Enrollment: 1100
Location and Contact Information:
National Institute of Mental Health (NIMH) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Linda Clair 3014969576
Additional Information:
Study ID Numbers: 810126; 81-M-0126
Study Start Date: August 24, 1981
Record last reviewed: August 13, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001177
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Study of Menstrually-Regulated Mood and Behavioral Disorder
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