Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359125
Status:
WITHDRAWN
Last Update Posted:
2014-01-22
First Post:
2006-07-28
Brief Title:
RU-486 in the Treatment of Bipolar Depression
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Efficacy of Mifepristone RU-486 in the Treatment of Bipolar Depression
Status:
WITHDRAWN
Status Verified Date:
2014-01
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 disorder is a chronic and recurrent illness which involves episodes of mania and depression It is believed that disturbance of the stress hormone system the hypothalamic-pituitary-adrenal or HPA axis may cause thinking and memory problems and make the depressive symptoms worse in bipolar disorder Early studies have shown that mifepristone may have antidepressant effects may improve the symptoms of depression and may also maintain or enhance cognition memory and thinking functions
The purpose of this study is to determine the potential therapeutic efficacy usefulness of mifepristone in bipolar depression by assessing the effects of the medication on depressive symptoms and on cognition This will be done by questionnaires and thinking tests
This study will also try to clarify the functional changes that accompany bipolar disorder by analyzing saliva samples assessing the stress response by measuring the levels of 2 stress hormones cortisol and DHEA
The purpose of this study is to determine the potential therapeutic efficacy usefulness of mifepristone in bipolar depression by assessing the effects of the medication on depressive symptoms and on cognition This will be done by questionnaires and thinking tests
This study will also try to clarify the functional changes that accompany bipolar disorder by analyzing saliva samples assessing the stress response by measuring the levels of 2 stress hormones cortisol and DHEA
Detailed Description:
Detailed Description
This study will be a parallel design randomized control trial Duration of study is 10 weeks per subject Following a baseline assessment of neurocognitive performance mood symptoms and neuroendocrine functioning HPA axis functioning bipolar depressed outpatients n100 will be randomized week 0 to receive either mifepristone 600 mg daily n50 or matching placebo n50 for 7 days Outcome measures will be completed at baseline pre-medication at the time of anticipated main response week 3 ie 2 weeks after cessation of treatment and at week 8 to determine the persistence of any effects
Neurocognitive performance pre and post mifepristone treatment will be evaluated with tests that have previously been shown to be affected by corticosteroids and to be abnormal in bipolar disorder The neurocognitive battery will measure learning and memory attention executive functioning and facial expression which has been shown to be a sensitive measure of affective shift
Mood symptoms will be evaluated at every study visit using standard clinician and patient self-rated scales
Neuroendocrine functioning HPA axis functioning will be measured by the dexamethasone suppression test DST response to dexamethasone This is a measure of the function of the glucocorticoid receptor Subjects will also be asked for salivary samples to measure the cortisol response to wakening and the ratio of cortisol to the protective steroid DHEA These validated tests will be used to improve our understanding of the mechanism of the therapeutic effect of mifepristone
Fifty 50 matched-healthy controls will also undergo the baseline assessments of neurocognitive performance mood symptoms and neuroendocrine functioning They will provide information about the pathophysiology of bipolar disorder
This study will be a parallel design randomized control trial Duration of study is 10 weeks per subject Following a baseline assessment of neurocognitive performance mood symptoms and neuroendocrine functioning HPA axis functioning bipolar depressed outpatients n100 will be randomized week 0 to receive either mifepristone 600 mg daily n50 or matching placebo n50 for 7 days Outcome measures will be completed at baseline pre-medication at the time of anticipated main response week 3 ie 2 weeks after cessation of treatment and at week 8 to determine the persistence of any effects
Neurocognitive performance pre and post mifepristone treatment will be evaluated with tests that have previously been shown to be affected by corticosteroids and to be abnormal in bipolar disorder The neurocognitive battery will measure learning and memory attention executive functioning and facial expression which has been shown to be a sensitive measure of affective shift
Mood symptoms will be evaluated at every study visit using standard clinician and patient self-rated scales
Neuroendocrine functioning HPA axis functioning will be measured by the dexamethasone suppression test DST response to dexamethasone This is a measure of the function of the glucocorticoid receptor Subjects will also be asked for salivary samples to measure the cortisol response to wakening and the ratio of cortisol to the protective steroid DHEA These validated tests will be used to improve our understanding of the mechanism of the therapeutic effect of mifepristone
Fifty 50 matched-healthy controls will also undergo the baseline assessments of neurocognitive performance mood symptoms and neuroendocrine functioning They will provide information about the pathophysiology of bipolar disorder
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 |
|---|---|---|---|
| H06-0093 | None | None | None |