Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043654
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2002-08-09
Brief Title:
Clinical Trial of Mifepristone for Bipolar Depression
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Antiglucocorticoid Therapy in Bipolar Depression With Mifepristone RU486
Status:
COMPLETED
Status Verified Date:
2007-06-25
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-M-0251 | None | None | None |