Trial Outcomes & Findings for A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features (NCT NCT00637494)
NCT ID: NCT00637494
Last Updated: 2017-06-05
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
292 participants
Primary outcome timeframe
56 days
Results posted on
2017-06-05
Participant Flow
Participant milestones
| Measure |
Mifepristone 1200 mg/Day
Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
|
Matching Placebo
Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
|
|---|---|---|
|
Overall Study
STARTED
|
141
|
151
|
|
Overall Study
COMPLETED
|
109
|
108
|
|
Overall Study
NOT COMPLETED
|
32
|
43
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features
Baseline characteristics by cohort
| Measure |
Mifepristone Followed by an Antidepressant
n=141 Participants
Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
|
Matching Placebo
n=151 Participants
Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
|
Total
n=292 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
141 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
46.2 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
141 participants
n=5 Participants
|
151 participants
n=7 Participants
|
292 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 56 daysResponse as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group administered mifepristone
Outcome measures
| Measure |
Active
n=141 Participants
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
n=151 Participants
Placebo followed by an antidepressant
placebo: Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days
|
|---|---|---|
|
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
|
51 participants
|
48 participants
|
SECONDARY outcome
Timeframe: 56 daysResponse 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
Outcome measures
| Measure |
Active
n=94 Participants
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
n=151 Participants
Placebo followed by an antidepressant
placebo: Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days
|
|---|---|---|
|
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
|
37 participants
|
48 participants
|
Adverse Events
Mifepristone 1200 mg/Day
Serious events: 3 serious events
Other events: 115 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 4 serious events
Other events: 103 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mifepristone 1200 mg/Day
n=141 participants at risk
Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
|
Matching Placebo
n=151 participants at risk
Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.71%
1/141 • Number of events 1
|
0.00%
0/151
|
|
Nervous system disorders
Psychotic Disorder
|
0.71%
1/141 • Number of events 1
|
0.00%
0/151
|
|
Nervous system disorders
Depression
|
0.71%
1/141 • Number of events 1
|
1.3%
2/151 • Number of events 2
|
|
Nervous system disorders
Suicidal Ideation
|
0.00%
0/141
|
1.3%
2/151 • Number of events 2
|
Other adverse events
| Measure |
Mifepristone 1200 mg/Day
n=141 participants at risk
Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
|
Matching Placebo
n=151 participants at risk
Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
17.7%
25/141 • Number of events 35
|
12.6%
19/151 • Number of events 20
|
|
Gastrointestinal disorders
Constipation
|
12.1%
17/141 • Number of events 20
|
9.3%
14/151 • Number of events 16
|
|
Gastrointestinal disorders
Diarrhoea
|
7.8%
11/141 • Number of events 11
|
9.3%
14/151 • Number of events 15
|
|
Gastrointestinal disorders
Dry Mouth
|
10.6%
15/141 • Number of events 15
|
6.0%
9/151 • Number of events 9
|
|
Gastrointestinal disorders
Dyspepsia
|
9.9%
14/141 • Number of events 16
|
6.0%
9/151 • Number of events 10
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
11/141 • Number of events 11
|
5.3%
8/151 • Number of events 8
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.0%
7/141 • Number of events 7
|
2.0%
3/151 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
7/141 • Number of events 9
|
2.0%
3/151 • Number of events 3
|
|
Nervous system disorders
Headache
|
23.4%
33/141 • Number of events 41
|
19.2%
29/151 • Number of events 32
|
|
Nervous system disorders
Dizziness
|
7.8%
11/141 • Number of events 11
|
6.0%
9/151 • Number of events 9
|
|
Psychiatric disorders
Insomnia
|
5.7%
8/141 • Number of events 9
|
10.6%
16/151 • Number of events 16
|
|
Psychiatric disorders
Anxiety
|
5.7%
8/141 • Number of events 8
|
6.0%
9/151 • Number of events 11
|
|
General disorders
Fatigue
|
6.4%
9/141 • Number of events 16
|
2.6%
4/151 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.4%
9/141 • Number of events 9
|
4.0%
6/151 • Number of events 6
|
|
Renal and urinary disorders
Pollakiuria
|
8.5%
12/141 • Number of events 15
|
3.3%
5/151 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER