Depression Clinical Trial
Official title:
The Treatment of Menstrually-Related Mood Disorders With Continuous Gonadal Steroid Replacement
Verified date | October 28, 2016 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study investigates the effects on symptoms of combined treatment with estrogen and
progesterone in women with severe premenstrual syndrome (PMDD).
Studies indicate that women with PMS experience improvement in symptoms following treatment
with leuprolide acetate, when estrogen and progesterone levels are low. Women with PMS, but
not women without the disorder, experience a return of symptoms within approximately a week
after re-exposure to either estrogen or progesterone. The cause of this hormone-induced
depression remains unclear. It is not known whether this depressed mood is due simply to the
change in the levels of estrogen and progesterone and whether it would remit following
continued exposure to stable levels of estrogen and progesterone. This study will determine
whether the maintenance of stable hormone levels will prevent mood disturbances in women with
PMS.
Participants in this study will receive leuprolide acetate injections once a month for up to
6 months. After 2 months, women whose symptoms have improved will receive a skin patch
containing either estrogen or placebo (an inactive substance) and will be asked to take daily
suppositories containing either progesterone or placebo. Women whose symptoms of PMS do not
respond to leuprolide treatment after 2 months will end the study and be offered other
treatment. Participants will be seen by a nurse in the clinic every two weeks and will fill
out ratings and have blood drawn to measure hormone levels.
Status | Completed |
Enrollment | 22 |
Est. completion date | October 28, 2016 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
- 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: 1. 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; 2. Symptoms with a sudden offset and absence of significant symptomatology during the follicular phase; 3. Age 18-50; 4. Regular menstrual cycles (21-35 days in length), not pregnant, and in good medical health; 5. Not pregnant; 6. 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: 1. Current Axis I psychiatric diagnosis 2. History of endometriosis; 3. Diagnosis of ill-defined, obscure pelvic lesions, particularly undiagnosed ovarian enlargement; 4. Hepatic disease as manifested by abnormal liver function tests; 5. History of mammary carcinoma; 6. History of pulmonary embolism or phlebothrombosis; 7. Undiagnosed vaginal bleeding; 8. Porphyries; 9. Diabetes mellitus; 10. History of malignant melanoma; 11. Cholecystitis or pancreatitis; 12. Cardiovascular or renal disease; 13. Pregnancy; 14. Significant clinical or laboratory abnormalities |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Mental Health (NIMH) |
United States,
Rubinow DR, Hoban MC, Grover GN, Galloway DS, Roy-Byrne P, Andersen R, Merriam GR. Changes in plasma hormones across the menstrual cycle in patients with menstrually related mood disorder and in control subjects. Am J Obstet Gynecol. 1988 Jan;158(1):5-11. — View Citation
Schmidt 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. — View Citation
Schmidt PJ, Nieman LK, Grover GN, Muller KL, Merriam GR, Rubinow DR. Lack of effect of induced menses on symptoms in women with premenstrual syndrome. N Engl J Med. 1991 Apr 25;324(17):1174-9. — View Citation
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