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Trial record 39 of 1054 for:    "Depressive Disorder" [DISEASE] AND Rating AND Hamilton Depression Rating Scale

Mifepristone in Refractory Depression

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ClinicalTrials.gov Identifier: NCT00186056
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : April 5, 2017
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Hugh Brent Solvason, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: Mifepristone
Drug: Placebo Oral Tablet
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mifepristone Placebo
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Patients received mifepristone for 6 days

Mifepristone: Glucocorticoid antagonist

Patients received placebo for 6 days

Mifepristone: Glucocorticoid antagonist

Period Title: Overall Study
Started 14 17
Completed 12 16
Not Completed 2 1
Arm/Group Title Mifepristone Placebo Total
Hide Arm/Group Description

Patients received mifepristone for 6 days

Mifepristone: Glucocorticoid antagonist

Patients received placebo for 6 days

Mifepristone: Glucocorticoid antagonist

Total of all reporting groups
Overall Number of Baseline Participants 14 17 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 17 participants 31 participants
50.92  (9.4) 51.82  (9.6) 51.43  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
Female
9
  64.3%
10
  58.8%
19
  61.3%
Male
5
  35.7%
7
  41.2%
12
  38.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   7.1%
0
   0.0%
1
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
7
  50.0%
7
  41.2%
14
  45.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
6
  42.9%
10
  58.8%
16
  51.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 17 participants 31 participants
14 17 31
1.Primary Outcome
Title Hamilton Depression Rating Scale
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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.

Time Frame Baseline and Day 35 HAMD scores
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone Placebo
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Patients received mifepristone for 6 days

Mifepristone: Glucocorticoid antagonist

Patients received placebo for 6 days

Mifepristone: Glucocorticoid antagonist

Overall Number of Participants Analyzed 12 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
18.75  (9.1) 19.68  (5.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mifepristone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.26
Comments [Not Specified]
Method ANOVA
Comments Interaction of HAMD * medication group F(2,26)=1.38, eta sq = .05
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description

Patients received mifepristone for 6 days

Mifepristone: Glucocorticoid antagonist

Patients received placebo for 6 days

Mifepristone: Glucocorticoid antagonist

All-Cause Mortality
Mifepristone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mifepristone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mifepristone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/17 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Brent Solvason
Organization: Stanford University
Phone: 650-723-8331
Responsible Party: Hugh Brent Solvason, Stanford University
ClinicalTrials.gov Identifier: NCT00186056     History of Changes
Other Study ID Numbers: 78804
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: October 13, 2016
Results First Posted: April 5, 2017
Last Update Posted: April 5, 2017