Trial Outcomes & Findings for Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose (NCT NCT01421134)
NCT ID: NCT01421134
Last Updated: 2016-07-15
Results Overview
The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
COMPLETED
PHASE3
211 participants
Baseline to Week 6
2016-07-15
Participant Flow
Participant milestones
| Measure |
Lurasidone
Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks
|
Placebo
Placebo
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
102
|
|
Overall Study
COMPLETED
|
102
|
87
|
|
Overall Study
NOT COMPLETED
|
7
|
15
|
Reasons for withdrawal
| Measure |
Lurasidone
Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks
|
Placebo
Placebo
Placebo: Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
5
|
|
Overall Study
Lack of Efficacy
|
2
|
4
|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Administrative
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
Baseline characteristics by cohort
| Measure |
Lurasidone
n=109 Participants
Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks
|
Placebo
n=100 Participants
Placebo
Placebo: Placebo
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
106 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 12.08 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 12.01 • n=7 Participants
|
44.9 years
STANDARD_DEVIATION 12.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
94 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
18 participants
n=5 Participants
|
13 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
26 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
30 participants
n=5 Participants
|
32 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 6Population: Intent to treat population
The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
Outcome measures
| Measure |
Lurasidone
n=108 Participants
Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks
|
Placebo
n=100 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores
|
-20.5 units on a scale
Standard Error 0.95
|
-13.0 units on a scale
Standard Error 1.00
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Intent to treat population
The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.
Outcome measures
| Measure |
Lurasidone
n=108 Participants
Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks
|
Placebo
n=100 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score
|
-1.83 units on a scale
Standard Error 0.109
|
-1.18 units on a scale
Standard Error 0.115
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Intent to treat population
The YMRS is an 11-item clinician-rated instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.
Outcome measures
| Measure |
Lurasidone
n=108 Participants
Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks
|
Placebo
n=100 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score
|
-7.0 units on a scale
Standard Error 0.35
|
-4.9 units on a scale
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Intent to treat population: If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.
The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).
Outcome measures
| Measure |
Lurasidone
n=70 Participants
Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks
|
Placebo
n=69 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score
|
-11.2 units on a scale
Standard Error 0.88
|
-6.4 units on a scale
Standard Error 0.88
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Intent to treat population. 3 Lurasidone subjects and 2 placebo subjects did not have post-baseline HAM-A assessment.
The HAM-A is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.
Outcome measures
| Measure |
Lurasidone
n=105 Participants
Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks
|
Placebo
n=98 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score
|
-9.9 units on a scale
Standard Error 0.58
|
-5.4 units on a scale
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Intent to treat population
Outcome measures
| Measure |
Lurasidone
n=108 Participants
Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks
|
Placebo
n=100 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF).
|
64.8 percentage of subjects
|
30.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Intent to treat population
Outcome measures
| Measure |
Lurasidone
n=108 Participants
Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks
|
Placebo
n=100 Participants
Placebo
Placebo: Placebo
|
|---|---|---|
|
Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)
|
49.1 percentage of subjects
|
23.0 percentage of subjects
|
Adverse Events
Lurasidone
Placebo
Serious adverse events
| Measure |
Lurasidone
n=109 participants at risk
Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks
|
Placebo
n=100 participants at risk
Placebo
Placebo: Placebo
|
|---|---|---|
|
Psychiatric disorders
Depression Suicidal
|
0.92%
1/109 • Number of events 1 • 6 Weeks
|
0.00%
0/100 • 6 Weeks
|
Other adverse events
| Measure |
Lurasidone
n=109 participants at risk
Lurasidone 20, 40 or 60 mg
Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks
|
Placebo
n=100 participants at risk
Placebo
Placebo: Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.4%
7/109 • Number of events 7 • 6 Weeks
|
2.0%
2/100 • Number of events 2 • 6 Weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.7%
4/109 • Number of events 5 • 6 Weeks
|
1.0%
1/100 • Number of events 1 • 6 Weeks
|
|
Gastrointestinal disorders
Dry mouth
|
2.8%
3/109 • Number of events 3 • 6 Weeks
|
1.0%
1/100 • Number of events 1 • 6 Weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.92%
1/109 • Number of events 1 • 6 Weeks
|
2.0%
2/100 • Number of events 3 • 6 Weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/109 • 6 Weeks
|
2.0%
2/100 • Number of events 2 • 6 Weeks
|
|
Nervous system disorders
Headache
|
5.5%
6/109 • Number of events 6 • 6 Weeks
|
6.0%
6/100 • Number of events 7 • 6 Weeks
|
|
Nervous system disorders
Somnoelence
|
4.6%
5/109 • Number of events 6 • 6 Weeks
|
1.0%
1/100 • Number of events 1 • 6 Weeks
|
|
Nervous system disorders
Akathisia
|
3.7%
4/109 • Number of events 4 • 6 Weeks
|
2.0%
2/100 • Number of events 2 • 6 Weeks
|
|
Nervous system disorders
Dizziness
|
3.7%
4/109 • Number of events 5 • 6 Weeks
|
3.0%
3/100 • Number of events 3 • 6 Weeks
|
|
Psychiatric disorders
Insomnia
|
5.5%
6/109 • Number of events 7 • 6 Weeks
|
11.0%
11/100 • Number of events 11 • 6 Weeks
|
|
Psychiatric disorders
Anxiety
|
3.7%
4/109 • Number of events 4 • 6 Weeks
|
9.0%
9/100 • Number of events 12 • 6 Weeks
|
|
Renal and urinary disorders
Haemarturia
|
0.00%
0/109 • 6 Weeks
|
2.0%
2/100 • Number of events 2 • 6 Weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.92%
1/109 • Number of events 1 • 6 Weeks
|
2.0%
2/100 • Number of events 2 • 6 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There IS agreement between Principal Investigator and Sponsor that restricts PI's rights to discuss or publish trial results after trial is completed. In addition to the \<60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication provided, if a multicenter publication is not forthcoming within 24 months post completion of study at all sites, PI shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER