NCT00186056

Brief Summary

The purpose of the study is to examine the effectiveness of mifepristone treatment in patients with refractory depression. Refractory depression is defined as clinical depression that is unimproved after treatment with at least 2 different antidepressants of adequate dose and time trial. Mifepristone will augment current medications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
9.9 years until next milestone

Results Posted

Study results publicly available

April 5, 2017

Completed
Last Updated

April 5, 2017

Status Verified

February 1, 2017

Enrollment Period

4.3 years

First QC Date

September 13, 2005

Results QC Date

October 13, 2016

Last Update Submit

February 17, 2017

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale

    Hamilton Depression Rating Scale. Minimum score of 0 (no depressive symptoms) to maximum of 68 (very severely depressed). Outcome Measure is reporting a Change from Baseline in HAMD scores, i.e., scores at Day 35 minus scores at Baseline.

    Baseline and Day 35 HAMD scores

Study Arms (2)

Mifepristone

EXPERIMENTAL

Patients received mifepristone for 6 days

Drug: Mifepristone

placebo

PLACEBO COMPARATOR

Patients received placebo for 6 days

Drug: Placebo Oral Tablet

Interventions

MifepristoneDRUG

Glucocorticoid antagonist

Also known as: RU 486
Mifepristone
Placebo Oral TabletDRUG

Inactive placebo tab

Also known as: sugar pill
placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • item HAM-D score of 20 or above.
  • If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least three weeks prior to entering the study.
  • At least 2 failed antidepressant medication trials of adequate dose and duration.
  • Between 18 and 75 years of age.

You may not qualify if:

  • Transcranial magnetic stimulation treatment or ECT in the 3 months prior to starting the study.
  • History of vagus nerve stimulation treatment.
  • No unstable or untreated cardiovascular disease, hypertension, or endocrine disorder.
  • Current use of oral contraceptives or any other drug that may result in adverse drug-mifepristone interactions effects (including Amiodarone, Clarithromycin, Erythromycin, Fluconazole, Fluvoxamine, Indinavir, Intraconazole, Ketoconazole, Metronidazole, Miconazole, Nefazodone, Nelfinavir, Norfloxacin, Omeprazole, Quinine, Ritonavir, Saquinavir, Troleandomycin, Zafirlukast, Carbamazepine, Dexamethasone, Ethosuximide, Phenobarbital, Phenytoin, Primidone, Rifabutin, Rifampin, Troglitazone). A 30-day wash-out period for oral contraceptives is required before mifepristone begins.
  • Previous allergic reaction to mifepristone or drugs of similar chemical structure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Depression

Interventions

MifepristoneSugars

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsCarbohydrates

Results Point of Contact

Title
Brent Solvason
Organization
Stanford University
solvason@stanford.edu
650-723-8331

Study Officials

  • Hugh Brent Solvason

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

January 1, 2003

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

April 5, 2017

Results First Posted

April 5, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)