Clinical Trial: Treatment of Psychotic Major Depression With Mifepristone

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Hypothalamic-Pituitary-Adrenal (HPA)/Dopamine Axis in Psychotic Depression

Brief Summary:

The purpose of this research study is to see how certain hormones cause changes in mood and thinking in some depressed patients and to determine the effectiveness of mifepristone in treating some forms of depression.

This study is conducted in conjunction with an observational study "Clinical and Biological Characteristics of Psychotic Depression".

Detailed Summary:

Eligibility Procedures: Before entering the study and prior to any other procedures, you will be asked to read and sign this consent form. To determine if you are eligible for our study, you will then have a general medical (including menstrual cycle history on female patients) and psychiatric history taken, a physical examination, your vital signs (blood pressure, pulse), height, weight and waist/hip ratio will be measured, as well as various psychiatric evaluations will be conducted.

You will be randomly (by chance) assigned to receive mifepristone or placebo (an inactive substance). Half of the participants in this research study will receive placebo, and half will receive mifepristone. Neither you nor your study doctor will know which of the two you are receiving. Treatment will begin in the morning of Treatment Day 1 and conclude on Treatment Day 8 for a total treatment period of 8 days. You will take the medication once a day in the morning. The dose was originally 600 mg but was changed to 1200 mg per day after the 4th patient. You will not be able to take any new medications (other than the study drug) or make changes to your current medications while participating in this part of the study unless ordered by the study physician.

On treatment Day 1, you will come to our office for an interview and we will evaluate your mood and other psychiatric symptoms. Additionally, we will take your vital signs and draw blood to administer clinical laboratory tests. You will meet with the study physician and will then be given 4-days of medication to take home with you and self-administer each morning.

On Treatment Day 4, you will come back to our office. We will evaluate your mood, take your vital signs and you will meet with the study physician. It is important that you discuss
Sponsor: Stanford University

Current Primary Outcome:

• Change in Psychotic Symptoms Subscale (PSS) of the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: baseline to day 9 ]

  The BRPS is a rating scale of various psychiatric symptoms. Each item is rated on a scale of 1 to 7, with 1 being not present. The PSS is the sum of 4 items from the BPRS, which indicates the level of positive psychotic symptoms.. Thus, the range for the PSS is 4 to 28, with higher scores indicating greater levels of positive psychotic symptoms.

  For ease of interpretation, the sum of the PSS then has 4 items subtracted so that a score of 0 (instead of 4) indicates that there are no psychotic symptoms. In doing this, the range for the PSS becomes 0 to 24), with larger values indicating more positive psychotic symptoms.

  The measure is the change score of PSS total day 1 less PSS total Day 9. 0 indicates no change, where as positive numbers indicate a decrease in psychotic symptoms.

• Change in Mean Cortisol Level [ Time Frame: Day 1 to Day 9 difference ]
  The reported value is the difference in mean evening cortisol from baseline to Day 9 The mean evening cortisol is calculated from the hourly cortisol value taken from 1800 hrs to 0100 hrs for both time points. The outcome measure is the difference of mean evening cortisol from Day 9 less the mean evening cortrisol from baseline. Negative values indicate a reduction in cortisol levels at Day 9, whereas positive values indicate an increase in cortisol at Day 9. Serum cortisol levels are reported in ug/dL

Original Primary Outcome:

• Change in psychotic symptoms
• Clinical improvement is associated with changes in cognition and HPA axis function (cortisol, ACTH)

Current Secondary Outcome: % Change in Mean Evening Pre- and Post- Florinef Cortisol After Treatment With Either Mifepristone or Placebo [ Time Frame: Day 23 ]

Original Secondary Outcome: Clinical improvement is associated with change in MR sensitivity

Information By: Stanford University

Dates:
Date Received: March 20, 2009
Date Started: August 2005
Date Completion:
Last Updated: February 15, 2017
Last Verified: February 2017