Hypothalamic-Pituitary-Adrenal (HPA) Axis in Psychotic Depression - Full Text View

Sponsors and Collaborators:	Stanford University National Institutes of Health (NIH)
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00576095

Purpose

The purpose of this study is to see how certain hormones cause changes in mood, thinking and brain structure in patients with major depression with psychotic features versus patients with non-psychotic depression and healthy controls. The researchers' goals are to understand the clinical, cognitive and biological differences between psychotic and non-psychotic depression. In addition, we will examine the effectiveness of using mifepristone to treat psychotic depression. Furthermore, we aim to understand the mechanisms of action of mifepristone.

Condition	Intervention
Psychotic Disorders Depression Depressive Disorder, Major	Drug: Mifepristone

MedlinePlus related topics: Depression Psychotic Disorders

Drug Information available for: Mifepristone Epinephrine Epinephrine bitartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	HPA Axis in Psychotic Depression

Further study details as provided by Stanford University:

Primary Outcome Measures:

Mifepristone's effect on stress hormone levels, cognition, and brain function.
Clinical and biological differences between Psychotic Depression and Non-Psychotic Depression, including cognitive functioning, stress hormones, and brain function.

Secondary Outcome Measures:

Efficacy and safety of treatment with Mifepristone

Estimated Enrollment:	100
Study Start Date:	August 2005
Estimated Study Completion Date:	March 2010

Detailed Description:

The study will recruit 50 subjects diagnosed with psychotic major depression (PMD), 25 subjects with non psychotic major depression (NPMD), and 25 healthy control subjects. Subjects will be 18-85 years of age, male or female, of any ethnic background. We include healthy control subjects so that we have a comparison group of non-symptomatic individuals.

All subjects (PMD's, NPMD's, and healthy controls) will undergo the eligibility screening. If they meet all the study requirements, they will be admitted to the to the General Clinical Research Center (GCRC) at Stanford Hospital for 2 nights and 3 days. We will obtain a waist /hip ratio, vitals, psychiatric ratings, and clinical laboratory tests. Additionally, subjects will undergo neuropsychiatric testing and an MRI scan.

Only the PMD patients will continue on in the study after Day 3. These patients will be randomly assigned to receive mifepristone or placebo under double blind conditions for a total treatment period of 8 days. Patients will be assessed on clinical ratings and adverse events on Treatment Days 15 and 22. On Day 22, patients will be readmitted for two nights to the GCRC where they will have their vitals taken, waist/hip ratio performed, clinical laboratory tests, neuropsychiatric testing and an MRI scan. Patients will be followed up at 1 week, 2 weeks and 1, 3, 6 and 12 months post treatment. Patients who initially received placebo and are still symptomatic will be offered 8 days of open-label mifepristone on an outpatient basis immediately following placebo treatment. These patients will be assessed clinically and for adverse events on Treatment Days 4, 18, 15 and 22 (1-week and 2-week post-treatment follow-up).

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:for PMD (psychotic major depression) and NPMDs (non-psychotic major depression) are as follows:

Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) diagnosis of major depressive disorder with or without psychotic features, bipolar II disorder with psychotic features in a major depressive episode.
21-item Hamilton Rating Scale for Depression (HAM-D) score greater than or equal to 21.
Thase Core Endogenomorphic Scale score greater than or equal to 6 on the items included in the 21-item HDRS (Hamilton Depression Rating Scale).
Between 18 - 85 years of age.
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.
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.
Pre-existing (current) primary treating psychiatrist for subjects with psychotic features.
Any secondary diagnoses from the anxiety disorder spectrum is acceptable, with the exclusion of obsessive-compulsive disorder (OCD).

Inclusion criteria for healthy controls are as follows:

Between 18 - 85 years of age.
Have a HAM-D score of less than or equal to 5.

Exclusion Criteria:for PMDs and NPMDs are as follows:

Electroconvulsive therapy (ECT) in the 6 months prior to the study.
Abuse of drugs or alcohol in the 6 months prior to study.
Unstable or untreated hypertension, cardiovascular disease, or endocrine disorders.
Use of additional prescription medications, street drugs, or alcohol during the week before the study and during the study.
Previous mifepristone failure or non-response.
Any Axis II diagnosis or traits which would make participation in the study difficult.
Current pregnancy or lactation.

Exclusion criteria for healthy controls:

Personal history of Axis I or Axis II disorders.
Active medical problems.
Abuse of drugs or alcohol in the 6 months prior to study.
Use of additional prescription medications, street drugs, or alcohol during the week before the study and during the study.
Currently pregnant or lactating.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576095

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Greg Cohen 650-723-3305 ghcohen@stanford.edu
Principal Investigator: Anna Lembke
Study Director: Jennifer Keller

Sponsors and Collaborators

Stanford University

National Institutes of Health (NIH)

Investigators

Study Director:

Jennifer Keller

Stanford University

More Information

Study ID Numbers:	2 R01 MH050604-10, MH50604
Study First Received:	December 14, 2007
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00576095
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia
Depression
Mental Disorders
Mood Disorders
Mifepristone
Psychotic Disorders

Depressive Disorder, Major
Epinephrine
Depressive Disorder
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms

Additional relevant MeSH terms:

Abortifacient Agents, Steroidal
Contraceptives, Postcoital, Synthetic
Disease
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female

Reproductive Control Agents
Luteolytic Agents
Contraceptives, Postcoital
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Abortifacient Agents
Menstruation-Inducing Agents
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on January 16, 2009