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Sponsored by: |
Corcept Therapeutics |
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Information provided by: | Corcept Therapeutics |
ClinicalTrials.gov Identifier: | NCT00637494 |
Approximately 450 patients will be randomized to receive CORLUX™ (Mifepristone) or placebo for 7 days followed by antidepressant. The purpose is to compare the efficacy of CORLUX followed by antidepressant versus placebo followed by antidepressant in reducing psychotic symptoms in patients with a diagnosis of psychotic depression.
Condition | Intervention | Phase |
---|---|---|
Psychotic Depression Major Depression With Psychotic Features Psychosis |
Drug: mifepristone Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of CORLUX (Mifepristone) vs. Placebo in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features |
Estimated Enrollment: | 450 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
CORLUX (mifepristone) followed by an antidepressant
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Drug: mifepristone
1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days
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2: Placebo Comparator
Placebo followed by an antidepressant
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Drug: placebo
Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days
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Up to 450 patients with psychotic depression will be randomly assigned to receive either CORLUX or matching placebo. Patients will be assessed by the Investigator or site staff during screening and on study days. A single antidepressant selected from a list of approved drugs will be administered after the administration of investigational drug. Adverse events, laboratory assessments, electrocardiograms, and physical examinations will be used to assess safety.
Ages Eligible for Study: | 22 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Thaddeus Block, MD | 650-327-3270 | tblock@corcept.com |
Contact: Janet Diehl, BS | 650-327-3270 |
Study Director: | Thaddeus Block, MD | Corcept Therapeutics |
Responsible Party: | Corcept Therapeutics ( Thaddeus Block, M.D., Medical Director ) |
Study ID Numbers: | C-1073-14 |
Study First Received: | March 11, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00637494 |
Health Authority: | United States: Food and Drug Administration |
psychotic depression major depression with psychotic features psychosis |
Schizophrenia Affective Disorders, Psychotic Depression Mental Disorders Bipolar Disorder Mood Disorders |
Mifepristone Psychotic Disorders Depressive Disorder, Major Depressive Disorder Schizophrenia and Disorders with Psychotic Features Behavioral Symptoms |
Abortifacient Agents, Steroidal Contraceptives, Postcoital, Synthetic Contraceptive Agents Hormone Antagonists Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists |
Reproductive Control Agents Contraceptives, Postcoital Luteolytic Agents Pharmacologic Actions Therapeutic Uses Abortifacient Agents Menstruation-Inducing Agents Contraceptives, Oral, Synthetic |