The Treatment of Menstrually-Related Mood Disorders With Extended Versus Interrupted Oral Contraceptives

Fecha de inicio: 1 de julio de 2004

* INCLUSION CRITERIA (are from protocol 81-M-0126 and are as follows): * Subjects who meet criteria for MRMD are healthy (by physical exam, normal pelvic exam and pap smear, and normal lab values) and medication free will be included in this study. * Oral contraceptives (and CDB-2914 in arm #3) will not be administered to any subject with significant clinical or laboratory abnormalities. EXCLUSION CRITERIA: Any patient with a current axis I psychiatric diagnosis will be excluded from participating in this protocol. Subjects taking psychotropic agents (e.g. antidepressants, anxiolytics or mood stabilizers) will likewise be excluded from the study. Women who have received glucocorticoid or megestrol therapy within the last year (and thus may experience residual suppression of the compensatory HPA axis response to CDB-2914-induced glucocorticoid receptor antagonism) will be also excluded, albeit almost entirely on theoretical grounds. Women who have any chronic medical conditions or are taking medications will be excluded. Women who have a medical condition or are taking any chronic medications that may increase serum potassium levels will also be excluded. Those patients who would be uncomfortable with extending the length of their menstrual cycles will not be enrolled in this study and will either be offered participation in another study or an outside referral for treatment in the community. The following conditions will constitute contraindications to treatment with continuous oral contraception or the use of the progesterone antagonist, CDB-2914, and will preclude a patient's participating in this protocol: * history of endometriosis, or recent, rapid growth of uterine fibroid tumors (defined as doubling in size in six month period); * diagnosis of ill-defined, obscure pelvic lesions, particularly undiagnosed ovarian enlargement; * hepatic disease as manifested by abnormal liver function tests; * history of breast carcinoma; * history of pulmonary embolism or phlebothrombosis; * undiagnosed vaginal bleeding; * porphyria; * history of malignant melanoma; * history of cholecystitis or pancreatitis; * history of hypercholesterolemia, hypertension, diabetes, or renal disease; * recurrent migraine headaches (greater than or equal to 3 per year) in women 35 or older; * pregnancy or lactation; * cigarette smoking in women 35 or older, or more than 10 cigarettes per day in women under 35; or * use of oral, injectable, or inhaled glucocorticoids or megestrol within the last year.