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NCT00043654 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial of Mifepristone for Bipolar Depression
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
NCT00043654: Completed Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
NCT00043654 is a Phase 2 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 110 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00043654, a Phase 2 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
Study 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.
Interventions
- DRUG Mifepristone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2002-08-07 |
| Est. Completion | 2007-06-25 |
| Phase | Phase 2 |
What the finished NCT00043654 record still lists
NCT00043654 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 1 intervention - of which Mifepristone is the first listed.
NCT00043654 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00043654 about?
NCT00043654 is a clinical study titled "Clinical Trial of Mifepristone for Bipolar Depression". 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 ...
What is the current status of trial NCT00043654?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2002-08-07. Estimated completion is 2007-06-25.
What interventions are being tested in trial NCT00043654?
The interventions under investigation include: Mifepristone (DRUG).
Who is sponsoring clinical trial NCT00043654?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00043654's enrollment target sits among peer trials
110 632nd of 2000 higher than 1,361 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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