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Treatment of Psychotic Major Depression With Mifepristone

This study has been terminated.
(Insufficient recruitment.)
Sponsor:
Information provided by (Responsible Party):
Alan Schatzberg, Stanford University
ClinicalTrials.gov Identifier:
NCT00867360
First received: March 20, 2009
Last updated: February 15, 2017
Last verified: February 2017
  Purpose

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".


Condition Intervention Phase
Affective Disorders, Psychotic Depressive Disorder Drug: Mifepristone (RU-486) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Hypothalamic-Pituitary-Adrenal (HPA)/Dopamine Axis in Psychotic Depression

Resource links provided by NLM:


Further study details as provided by Alan Schatzberg, Stanford University:

Primary Outcome Measures:
  • 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


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

    Time 1 (baseline) = Difference in cortisol level from Day 1 (pre-florinef mean evening cortisol) at Baseline less Day 2 (post-florinef mean evening cortisol) at baseline

    Time 2 (post- mife or placebo treatment) = Difference in cortisol level from Day 22 (pre-florinef mean evening cortisol) and Day 23 (post-florinef mean evening cortisol level).

    All measurements were the percent change in mean cortisol level from 6 pm to 10 pm. Cortisol levels are expressed as ug/dL

    Percent change in cortisol decrease between Time 2 and Time 1 post florinef should be greater with mifepristone than placebo, reflecting enhanced mineralocorticoid receptor activity.



Enrollment: 10
Study Start Date: August 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mifepristone
Receive mifepristone for 8 days
Drug: Mifepristone (RU-486)
Placebo Comparator: Placebo
Receive placebo rather than mifepristone
Drug: Placebo
Placebo medication

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Inclusion criteria for PMD (individuals with Psychotic Major Depression) are as follows:

  1. DSM IV diagnosis of Major Depressive Disorder with psychotic features, Bipolar II Disorder with psychotic features in a major depressive episode.
  2. 21-item HAM-D score greater than or equal to 21.
  3. Thase Core Endogenomorphic Scale score greater than or equal to 6 on the items included in the 21-item HDRS.
  4. Between 21 - 85 years of age.
  5. Female patients of child bearing capacity with Psychotic Depression receiving treatment with mifepristone are required to use a double-barrier method of contraception or abstinence for the entire duration of the study as well as for thirty days after the last dose of Mifepristone is taken.
  6. If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least one-week prior to entering the study.
  7. Pre-existing (current) primary treating psychiatrist for subjects with psychotic features.
  8. Any secondary diagnoses from the anxiety disorder spectrum is acceptable. Any secondary diagnoses from the anxiety disorder spectrum is acceptable. Primary pre-existing chronic Obsessive-Compulsive Disorder(OCD) will be an exclusion criteria.

Exclusion Criteria:Exclusion criteria for PMDs are as follows:

  1. ECT in the 6 months prior to the study.
  2. Abuse of drugs or alcohol in the 6 months prior to study.
  3. Unstable or untreated hypertension, cardiovascular disease.
  4. If participating in the blood draw portion of the protocol, endocrine disorders are exclusionary.
  5. Use of additional prescription medications, street drugs, or alcohol during the week before the study.
  6. Previous mifepristone failure or non-response.
  7. Any Axis II diagnosis or traits which would make participation in the study difficult.
  8. Current pregnancy or lactation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867360

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Fredric B Kraemer Stanford University
  More Information

Responsible Party: Alan Schatzberg, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00867360     History of Changes
Other Study ID Numbers: SU-02262009-1838
Study First Received: March 20, 2009
Results First Received: November 15, 2016
Last Updated: February 15, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Disease
Depression
Depressive Disorder
Mood Disorders
Mental Disorders
Psychotic Disorders
Affective Disorders, Psychotic
Pathologic Processes
Behavioral Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents

ClinicalTrials.gov processed this record on June 26, 2017