The Treatment of Menstrually-Related Mood Disorders With Continuous Gonadal Steroid Replacement
Data Collection
Behavior+4
+ Behavioral Symptoms
+ Menstruation Disturbances
Summary
Study start date: March 28, 2000
Actual date on which the first participant was enrolled.Results from previous protocols (#90-M-0088 and 92-M-0174) have demonstrated that women with menstrually-related mood disorder (MRMD), but not women lacking this disorder, experience mood deterioration within approximately a week after exposure to either estradiol or progesterone in the context of gonadal suppression (induced by use of the depot gonadotropin releasing hormone agonist, leuprolide acetate). It is unknown whether this hormone-induced depression occurs consequent to changes in gonadal steroid levels or to simple exposure to levels above a critical threshold. Additionally, since the symptoms of depression stimulated by hormone addback appeared to remit by the fourth week of hormone administration, it is unclear whether continued administration of hormone would result in continued or repeated experience of depression or whether no further symptoms would appear subsequent to the initial precipitated episode. To address these points of uncertainty, we first will establish the efficacy of gonadal suppression in our MRMD subjects by administering depot leuprolide acetate for three months and then will administer both estradiol and progesterone in a continuous fashion for three months to determine whether maintenance of stable gonadal steroid levels will prevent the characteristic cyclic mood disorder.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.22 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
INCLUSION CRITERIA: The subjects of this study will be women who meet the criteria for MRMD as described in Protocol # 81-M-0126, The Phenomenology and Biophysiology of Menstrually-related Mood and Behavioral Disorders. In brief, these criteria include the following: History within the last two years of at least six months with menstrually-related mood or behavioral disturbances of at least moderate severity--i.e., disturbances that are distinct in appearance and associated with a notable degree of subjective distress and interference with life activities; Symptoms with a sudden offset and absence of significant symptomatology during the follicular phase; Age 18-50; Regular menstrual cycles (21-35 days in length), not pregnant, and in good medical health; Not pregnant; In good medical health; 5) Medication free. All patients participating in this protocol will have already participated in Protocol No. 81-M-0126 and will have a prospectively confirmed and predictable relationship between their mood disorder and the premenstrual phase of the menstrual cycle; i.e., a 30% change in severity of symptom self rating scales, relative to the range of the scale employed, during the seven days premenstrually compared with the seven days post-menstrually in two out of three months of study. This method formed the basis of the NIMH PMS Workgroup diagnostic guidelines and produces results that are highly convergent with the effect size method for diagnosing PMS. All subjects will be required to use non-hormonal forms of birth control (e.g. barrier methods with the exception of IUD s) to avoid pregnancy during this study. EXLUSION CRITERIA: The following conditions, also, will constitute contraindications to treatment with hormonal therapy and will preclude a patient's participating in this protocol: Current Axis I psychiatric diagnosis History of endometriosis; Diagnosis of ill-defined, obscure pelvic lesions, particularly undiagnosed ovarian enlargement; Hepatic disease as manifested by abnormal liver function tests; History of mammary carcinoma; History of pulmonary embolism or phlebothrombosis; Undiagnosed vaginal bleeding; Porphyries; Diabetes mellitus; History of malignant melanoma; Cholecystitis or pancreatitis; Cardiovascular or renal disease; Pregnancy; Significant clinical or laboratory abnormalities
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps