Trial Outcomes & Findings for Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy) (NCT NCT00868699)
NCT ID: NCT00868699
Last Updated: 2014-04-17
Results Overview
Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.
COMPLETED
PHASE3
505 participants
Baseline to Week 6
2014-04-17
Participant Flow
4/29/09 to 2/1/12
Participant milestones
| Measure |
Placebo
Placebo : Placebo Comparator
|
Lurasidone High Arm
lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
|
Lurasidone Low Arm
lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
|
|---|---|---|---|
|
Overall Study
STARTED
|
170
|
169
|
166
|
|
Overall Study
Intent-to-Treat Population
|
162
|
162
|
161
|
|
Overall Study
Safety Population
|
168
|
167
|
164
|
|
Overall Study
COMPLETED
|
127
|
124
|
123
|
|
Overall Study
NOT COMPLETED
|
43
|
45
|
43
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)
Baseline characteristics by cohort
| Measure |
Placebo
n=162 Participants
Placebo : Placebo Comparator
|
Lurasidone High Arm
n=162 Participants
lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
|
Lurasidone Low Arm
n=161 Participants
lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
|
Total
n=485 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
159 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
473 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Continuous
|
41.2 years
STANDARD_DEVIATION 12.45 • n=5 Participants
|
42.0 years
STANDARD_DEVIATION 12.35 • n=7 Participants
|
41.3 years
STANDARD_DEVIATION 12.31 • n=5 Participants
|
41.5 years
STANDARD_DEVIATION 12.35 • n=4 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
276 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
70 participants
n=7 Participants
|
67 participants
n=5 Participants
|
195 participants
n=4 Participants
|
|
Region of Enrollment
Czech Republic
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
17 participants
n=5 Participants
|
55 participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
16 participants
n=5 Participants
|
49 participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
9 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
19 participants
n=5 Participants
|
54 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
Region of Enrollment
India
|
27 participants
n=5 Participants
|
23 participants
n=7 Participants
|
23 participants
n=5 Participants
|
73 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 6Population: Intent-to-treat population is analyzed.
Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.
Outcome measures
| Measure |
Placebo
n=162 Participants
Placebo : Placebo Comparator
|
Lurasidone High Arm
n=162 Participants
lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
|
Lurasidone Low Arm
n=161 Participants
lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
|
|---|---|---|---|
|
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
|
-10.7 units on a scale
Standard Error 0.83
|
-15.4 units on a scale
Standard Error 0.83
|
-15.4 units on a scale
Standard Error 0.83
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Intent-to-treat population is analyzed.
Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression. The CGI depression score ranges from a minimum of 0 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.
Outcome measures
| Measure |
Placebo
n=162 Participants
Placebo : Placebo Comparator
|
Lurasidone High Arm
n=162 Participants
lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
|
Lurasidone Low Arm
n=161 Participants
lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
|
|---|---|---|---|
|
Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
|
-1.14 units on a scale
Standard Error 0.102
|
-1.71 units on a scale
Standard Error 0.101
|
-1.83 units on a scale
Standard Error 0.102
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Intent-to-treat population is analyzed. Number of participants in table is not consistent with intent-to-treat population because: if one or more items are missing at a study visit, as can occur when a subject opts out of the work/school item because it does not apply, the authors of the scale recommend setting the total score to missing
Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression. The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items.
Outcome measures
| Measure |
Placebo
n=100 Participants
Placebo : Placebo Comparator
|
Lurasidone High Arm
n=105 Participants
lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
|
Lurasidone Low Arm
n=88 Participants
lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
|
|---|---|---|---|
|
Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
|
-6.3 units on a scale
Standard Error 0.77
|
-9.8 units on a scale
Standard Error 0.73
|
-9.5 units on a scale
Standard Error 0.81
|
Adverse Events
Placebo
Lurasidone High Arm
Lurasidone Low Arm
Serious adverse events
| Measure |
Placebo
n=168 participants at risk
Placebo : Placebo Comparator
|
Lurasidone High Arm
n=167 participants at risk
lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
|
Lurasidone Low Arm
n=164 participants at risk
lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
|
|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/168 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
1.2%
2/167 • Number of events 2 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
1.2%
2/164 • Number of events 2 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/168 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
0.60%
1/167 • Number of events 1 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
0.61%
1/164 • Number of events 1 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/168 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
0.60%
1/167 • Number of events 1 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
0.00%
0/164 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
|
Injury, poisoning and procedural complications
Restless Leg Syndrome
|
0.00%
0/168 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
0.60%
1/167 • Number of events 1 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
0.00%
0/164 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
|
Infections and infestations
HIV Infection
|
0.00%
0/168 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
0.60%
1/167 • Number of events 1 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
0.00%
0/164 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
|
Infections and infestations
Subcutaneous Absceses
|
0.00%
0/168 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
0.60%
1/167 • Number of events 1 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
0.00%
0/164 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.60%
1/168 • Number of events 1 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
0.00%
0/167 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
0.00%
0/164 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
Other adverse events
| Measure |
Placebo
n=168 participants at risk
Placebo : Placebo Comparator
|
Lurasidone High Arm
n=167 participants at risk
lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
|
Lurasidone Low Arm
n=164 participants at risk
lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.7%
13/168 • Number of events 87 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
17.4%
29/167 • Number of events 38 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
10.4%
17/164 • Number of events 24 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
|
Nervous system disorders
Headache
|
11.9%
20/168 • Number of events 25 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
9.0%
15/167 • Number of events 16 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
14.0%
23/164 • Number of events 36 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
|
Nervous system disorders
Akathisia
|
2.4%
4/168 • Number of events 6 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
10.8%
18/167 • Number of events 23 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
7.9%
13/164 • Number of events 18 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
|
Psychiatric disorders
Insomnia
|
8.3%
14/168 • Number of events 19 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
6.6%
11/167 • Number of events 16 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
4.9%
8/164 • Number of events 12 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
|
Nervous system disorders
Somnolence
|
4.2%
7/168 • Number of events 7 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
6.6%
11/167 • Number of events 13 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
4.3%
7/164 • Number of events 7 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
|
Nervous system disorders
Sedation
|
1.8%
3/168 • Number of events 3 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
7.2%
12/167 • Number of events 13 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
3.0%
5/164 • Number of events 6 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
|
Nervous system disorders
Dizziness
|
7.7%
13/168 • Number of events 13 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
6.0%
10/167 • Number of events 12 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
2.4%
4/164 • Number of events 5 • April 29,2009 - February 1, 2012
Safety population is analyzed.
|
Additional Information
Medical Director, CNS
Sunovion
Results disclosure agreements
- Principal investigator is a sponsor employee 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 following completion of study at all sites, the PI shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER