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Trial record 16 of 58475 for:    Placebo

A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features

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ClinicalTrials.gov Identifier: NCT00637494
Recruitment Status : Terminated (DRC recommended stopping study as it had missed its primary endpoint)
First Posted : March 18, 2008
Results First Posted : February 16, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Psychotic Depression
Severe Major Depression With Psychotic Features
Psychosis
Interventions Drug: mifepristone
Drug: placebo
Enrollment 292
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mifepristone 1200 mg/Day Matching Placebo
Hide Arm/Group Description Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56 Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
Period Title: Overall Study
Started 141 151
Completed 109 108
Not Completed 32 43
Arm/Group Title Mifepristone Followed by an Antidepressant Matching Placebo Total
Hide Arm/Group Description Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56 Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56 Total of all reporting groups
Overall Number of Baseline Participants 141 151 292
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 151 participants 292 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
141
 100.0%
147
  97.4%
288
  98.6%
>=65 years
0
   0.0%
4
   2.6%
4
   1.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 141 participants 151 participants 292 participants
45.4  (9.0) 47.0  (9.5) 46.2  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 151 participants 292 participants
Female
76
  53.9%
85
  56.3%
161
  55.1%
Male
65
  46.1%
66
  43.7%
131
  44.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 141 participants 151 participants 292 participants
141 151 292
1.Primary Outcome
Title Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PSS) at Days 7 and 56
Hide Description Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group administered mifepristone
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Placebo
Hide Arm/Group Description:

Mifepristone followed by an antidepressant

mifepristone: 1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days

Placebo followed by an antidepressant

placebo: Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days

Overall Number of Participants Analyzed 141 151
Measure Type: Number
Unit of Measure: participants
51 48
2.Secondary Outcome
Title Proportion of Mifepristone Treated Patients With Plasma Drug Concentrations Equal to or Above 1637 ng/mL vs. Placebo Treated Patients Who Achieve a ≤ 50% Reduction in BPRS-PSS at Days 7 and 56
Hide Description Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group who achieved a sufficiently high plasma level of mifepristone
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Placebo
Hide Arm/Group Description:

Mifepristone followed by an antidepressant

mifepristone: 1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days

Placebo followed by an antidepressant

placebo: Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days

Overall Number of Participants Analyzed 94 151
Measure Type: Number
Unit of Measure: participants
37 48
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mifepristone 1200 mg/Day Matching Placebo
Hide Arm/Group Description Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56 Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
All-Cause Mortality
Mifepristone 1200 mg/Day Matching Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mifepristone 1200 mg/Day Matching Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/141 (2.13%)      4/151 (2.65%)    
Nervous system disorders     
Psychotic Disorder   1/141 (0.71%)  1 0/151 (0.00%)  0
Depression   1/141 (0.71%)  1 2/151 (1.32%)  2
Suicidal Ideation   0/141 (0.00%)  0 2/151 (1.32%)  2
Respiratory, thoracic and mediastinal disorders     
Chronic Obstructive Pulmonary Disease   1/141 (0.71%)  1 0/151 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mifepristone 1200 mg/Day Matching Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   115/141 (81.56%)      103/151 (68.21%)    
Gastrointestinal disorders     
Nausea   25/141 (17.73%)  35 19/151 (12.58%)  20
Constipation   17/141 (12.06%)  20 14/151 (9.27%)  16
Diarrhoea   11/141 (7.80%)  11 14/151 (9.27%)  15
Dry Mouth   15/141 (10.64%)  15 9/151 (5.96%)  9
Dyspepsia   14/141 (9.93%)  16 9/151 (5.96%)  10
Vomiting   11/141 (7.80%)  11 8/151 (5.30%)  8
Abdominal Pain   7/141 (4.96%)  7 3/151 (1.99%)  3
Abdominal pain upper   7/141 (4.96%)  9 3/151 (1.99%)  3
General disorders     
Fatigue   9/141 (6.38%)  16 4/151 (2.65%)  4
Nervous system disorders     
Headache   33/141 (23.40%)  41 29/151 (19.21%)  32
Dizziness   11/141 (7.80%)  11 9/151 (5.96%)  9
Psychiatric disorders     
Insomnia   8/141 (5.67%)  9 16/151 (10.60%)  16
Anxiety   8/141 (5.67%)  8 9/151 (5.96%)  11
Renal and urinary disorders     
Pollakiuria   12/141 (8.51%)  15 5/151 (3.31%)  5
Skin and subcutaneous tissue disorders     
Rash   9/141 (6.38%)  9 6/151 (3.97%)  6
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Thaddeus S. Block, MD
Organization: Corcept Therapeutics
Phone: (650) 688-8816
Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00637494     History of Changes
Other Study ID Numbers: C-1073-14
First Submitted: March 11, 2008
First Posted: March 18, 2008
Results First Submitted: December 23, 2016
Results First Posted: February 16, 2017
Last Update Posted: June 5, 2017