Clinical Trials Logo

Clinical Trial Summary

Approximately 450 patients will be randomized to receive Mifepristone or placebo for 7 days followed by antidepressant. The purpose is to compare the efficacy of Mifepristone followed by antidepressant versus placebo followed by antidepressant in reducing psychotic symptoms in patients with a diagnosis of psychotic depression.


Clinical Trial Description

Up to 450 patients with psychotic depression will be randomly assigned to receive either Mifepristone 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00637494
Study type Interventional
Source Corcept Therapeutics
Contact
Status Terminated
Phase Phase 3
Start date March 2008
Completion date June 2014

See also
  Status Clinical Trial Phase
Recruiting NCT04929938 - Application of UP for Transdiagnostic Treatment of Emotional Disorders for UHR for Psychosis Patients N/A
Recruiting NCT05863572 - Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda N/A
Completed NCT04277585 - Improving Access to Early Psychosis Coordinated Specialty Care N/A
Recruiting NCT06197048 - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Terminated NCT04404712 - FAAH Availability in Psychiatric Disorders: A PET Study Early Phase 1
Recruiting NCT05769933 - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Not yet recruiting NCT05558332 - Youth Nominated Support Team N/A
Not yet recruiting NCT05358457 - Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf) N/A
Not yet recruiting NCT03807388 - ReMindCare App for Patients From First Episode of Psychosis Unit. N/A
Completed NCT02895269 - COllaborative Shared Care to IMprove Psychosis Outcome N/A
Recruiting NCT02622048 - Understanding and Helping Families: Parents With Psychosis N/A
Completed NCT02733575 - Compassion Focused Therapy for Distressing Experiences N/A
Completed NCT02653729 - Cbt for Psychosis and Affect on Psychosis Symptoms Phase 2
Completed NCT02531243 - Computer-Aided Learning for Managing Stress N/A
Not yet recruiting NCT02244970 - Mindfulness RCT for Early Psychosis N/A
Enrolling by invitation NCT01364818 - Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment N/A
Withdrawn NCT00786318 - Ziprasidone vs Standard Therapy for Agitated Patients in the ED Phase 4
Recruiting NCT00722163 - A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis Phase 0