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NCT00043654
Clinical Trial of Mifepristone for Bipolar Depression
Phase 2 trial testing Mifepristone in Bipolar Disorder in 110 participants. Completed in 25 June 2007.
Quick facts
| Lead sponsor | National Institute of Mental Health (NIMH) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Primary purpose | treatment |
| Enrollment | 110 |
| Start date | 7 August 2002 |
| Estimated completion | 25 June 2007 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Mifepristone (MIFEPRISTONE) — full drug profile →
Conditions studied
- Bipolar Disorder — all drugs for Bipolar Disorder →
Sponsor
National Institute of Mental Health (NIMH)
Who can join
Adults 18 to 75, any sex, with Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Hormonal Treatments for Major Depressive Disorder: State of the Art.
Dwyer JB, Aftab A, Radhakrishnan R, Widge A, et al · · 2020 · cited 177× · PMID 32456504 · DOI 10.1176/appi.ajp.2020.19080848
Verify or expand the search:
- PubMed search for NCT00043654
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00043654 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Mental Health (NIMH)
- Last refreshed: 2 July 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00043654.
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