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A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features

NCT00637494 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2017-06-05

Study results available
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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.

Conditions

  • Psychotic Depression
  • Severe Major Depression With Psychotic Features
  • Psychosis

Interventions

DRUG

mifepristone

1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days

DRUG

placebo

Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days

Sponsors & Collaborators

  • Corcept Therapeutics

    lead INDUSTRY

Principal Investigators

  • Thaddeus Block, MD · Corcept Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00637494 on ClinicalTrials.gov