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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 8, 2005 | ||||
| Last Updated Date | February 22, 2007 | ||||
| Start Date ICMJE | August 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
To evaluate the safety and tolerability of Corlux (mifepristone) for the treatment of recurrent psychotic symptoms with major depression with psychotic features (PMD) who previously participated in Corcept Therapeutics Protocol C-1073-09 | ||||
| Original Primary Outcome Measures ICMJE |
To evaluate the safety and tolerability of Corlux (mifepristone) for the treatment of recurrent psychotic symptoms with Major Depression with Psychotic Features (PMD) who previously participated in Corcept Therapeutics protocol C-1073-09. | ||||
| Change History | Complete list of historical versions of study NCT00128505 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To assess the frequency of retreatment with Corlux in patients with PMD and qualitatively describe the psychotic symptoms for which retreatment is clinically indicated | ||||
| Original Secondary Outcome Measures ICMJE |
To assess the frequency of retreatment with Corlux in patients with PMD and qualitatively describe the psychotic symptoms for which retreatment is clinically indicated. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | An International Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression | ||||
| Official Title ICMJE | An International, Open-Label Extension Study of the Safety and Tolerability of CORLUX™ (Mifepristone) for Recurrent Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features | ||||
| Brief Summary | Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. People who suffer from psychotic major depression may have unusually high levels of cortisol circulating within them or abnormal patterns of cortisol levels, overloading the stress response mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If Corlux can keep the body's cortisol receptors from being overloaded, the stress response system may return to normal function, which may result in improvement of symptoms. The purpose of this study is to allow patients who have already participated in an earlier 8 week study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment with Corlux periodically if a psychotic episode should reappear during a period of one year. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Mifepristone | ||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 110 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Bulgaria, Croatia, Former Serbia and Montenegro, Romania | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00128505 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | C-1073-13 | ||||
| Study Sponsor ICMJE | Corcept Therapeutics | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Corcept Therapeutics | ||||
| Verification Date | February 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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