Combined Hormone Replacement in Menstrually-Related Mood Disorders

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