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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00043654 |
Bipolar Depression is a severe illness with high rates of psychiatric comorbidity and increased mortality related to suicide and medical illness. Hypothalamic pituitary axis (HPA) hyperactivity are found in bipolar disorder related to depression and mixed states. Patients with bipolar disorder also have cognitive difficulties and endocrine disturbances may contribute to such dysfunction. Antiglucorticoid therapies are novel treatments of mood disorder. Preliminary data in psychotic depression suggesting that mifepristone (RU-486), a glucocorticoid receptor antagonist, has antidepressant and salutary cognitive effects in a matter of days. In this study we examine the effects of mifepristone in severe bipolar depression in a parallel, double blind placebo controlled experiment. Bipolar subjects maintained on either lithium or valproate, after washout or prior antidepressants have a detailed neuroendocrine assessment. Patients approximately or almost 75 will receive eight days of mifepristone versus placebo after which patients are blindly crossed over to the opposite arm. Patients and a group of matched controls approximately or almost 35 will be compared with neuroendocrine, cognitive, and neurophysiologic testing to fully characterize their phenotype and explore biomarkers of response. It is hypothesized that stigmata of HPA axis hyperactivity and cognitive impairment will be predictive of response to antiglucocorticoid therapy with mifepristone.
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder |
Drug: Mifepristone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Antiglucocorticoid Therapy in Bipolar Depression With Mifepristone (RU486) |
Estimated Enrollment: | 110 |
Study Start Date: | August 2002 |
Estimated Study Completion Date: | June 2007 |
Bipolar Depression is a severe illness with high rates of psychiatric comorbidity and increased mortality related to suicide and medical illness. Hypothalamic pituitary axis (HPA) hyperactivity are found in bipolar disorder related to depression and mixed states. Patients with bipolar disorder also have cognitive difficulties and endocrine disturbances may contribute to such dysfunction. Antiglucorticoid therapies are novel treatments of mood disorder. Preliminary data in psychotic depression suggesting that mifepristone (RU-486), a glucocorticoid receptor antagonist, has antidepressant and salutary cognitive effects in a matter of days. In this study we examine the effects of mifepristone in severe bipolar depression in a parallel, double blind placebo controlled experiment. Bipolar subjects maintained on either lithium or valproate, after washout or prior antidepressants have a detailed neuroendocrine assessment. Patients approximately or almost 75 will receive eight days of mifepristone versus placebo after which patients are blindly crossed over to the opposite arm. Patients and a group of matched controls approximately or almost 35 will be compared with neuroendocrine, cognitive, and neurophysiologic testing to fully characterize their phenotype and explore biomarkers of response. It is hypothesized that stigmata of HPA axis hyperactivity and cognitive impairment will be predictive of response to antiglucocorticoid therapy with mifepristone.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA FOR BIPOLAR PATIENTS:
Patients must meet the following inclusion criteria in order to participate in the study:
EXCLUSION CRITERIA FOR BIPOLAR PATIENTS:
Patients will be excluded from the study if they meet any of the following criteria:
INCLUSION CRITERIA FOR NORMAL CONTROLS:
EXCLUSION CRITERIA FOR NORMAL CONTROLS:
Study ID Numbers: | 020251, 02-M-0251 |
Study First Received: | August 9, 2002 |
Last Updated: | June 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00043654 |
Health Authority: | United States: Federal Government |
Antidepressant Manic-Depressive Disorder Cortisol Neuroendocrine Cognition |
Bipolar Bipolar Disorder BPD HV |
Depression Hydrocortisone Cortisol succinate Bipolar Disorder Mifepristone Depressive Disorder Behavioral Symptoms |
Affective Disorders, Psychotic Mental Disorders Bipolar disorder Mood Disorders Psychotic Disorders Hydrocortisone acetate |
Abortifacient Agents, Steroidal Contraceptives, Postcoital, Synthetic Contraceptive Agents Hormone Antagonists Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists |
Reproductive Control Agents Contraceptives, Postcoital Luteolytic Agents Pharmacologic Actions Therapeutic Uses Abortifacient Agents Menstruation-Inducing Agents Contraceptives, Oral, Synthetic |