Trial Outcomes & Findings for A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder. (NCT NCT01986114)
NCT ID: NCT01986114
Last Updated: 2022-04-12
Results Overview
The number and percentage of subjects with at least one adverse event and adverse drug reaction
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
495 participants
Primary outcome timeframe
28, 52 weeks
Results posted on
2022-04-12
Participant Flow
495 represents the total number of subjects who were treated with study drug.
Participant milestones
| Measure |
SM-13496 20-120mg
once daily orally
SM-13496 (lurasidone HCl): SM-13496 20-120mg
|
|---|---|
|
Overall Study
STARTED
|
495
|
|
Overall Study
COMPLETED
|
339
|
|
Overall Study
NOT COMPLETED
|
156
|
Reasons for withdrawal
| Measure |
SM-13496 20-120mg
once daily orally
SM-13496 (lurasidone HCl): SM-13496 20-120mg
|
|---|---|
|
Overall Study
Adverse Event
|
59
|
|
Overall Study
Lack of Efficacy
|
23
|
|
Overall Study
Withdrawal by Subject
|
58
|
|
Overall Study
Noncompliance
|
3
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Other reason
|
7
|
Baseline Characteristics
A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
Baseline characteristics by cohort
| Measure |
SM-13496 20-120mg
n=495 Participants
once daily orally
SM-13496 (lurasidone HCl): SM-13496 20-120mg
|
|---|---|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 12.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
259 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
236 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
225 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
270 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
199 participants
n=5 Participants
|
|
Region of Enrollment
Philippines
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
117 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
129 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28, 52 weeksThe number and percentage of subjects with at least one adverse event and adverse drug reaction
Outcome measures
| Measure |
SM-13496 20-120mg (Overall, 28 Weeks)
n=495 Participants
once daily orally
SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 28 weeks
|
SM-13496 20-120mg (Japan, 52 Weeks)
n=199 Participants
once daily orally
SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 52 weeks
|
|---|---|---|
|
Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR)
|
352 Participants
|
169 Participants
|
SECONDARY outcome
Timeframe: Baseline, 52 weeks and each monthMontgomery-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 |
SM-13496 20-120mg (Overall, 28 Weeks)
n=494 Participants
once daily orally
SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 28 weeks
|
SM-13496 20-120mg (Japan, 52 Weeks)
n=198 Participants
once daily orally
SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 52 weeks
|
|---|---|---|
|
Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score
|
-4.4 units on a scale
Standard Deviation 12.09
|
1.1 units on a scale
Standard Deviation 12.58
|
SECONDARY outcome
Timeframe: Baseline, 52 weeks and each monthYMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder. The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS 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 YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 items.
Outcome measures
| Measure |
SM-13496 20-120mg (Overall, 28 Weeks)
n=494 Participants
once daily orally
SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 28 weeks
|
SM-13496 20-120mg (Japan, 52 Weeks)
n=198 Participants
once daily orally
SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 52 weeks
|
|---|---|---|
|
Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score.
|
-1.0 units on a scale
Standard Deviation 4.54
|
-2.0 units on a scale
Standard Deviation 6.73
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksThe number and percentage of subjects who experienced recurrence/relapse of any mood event from clinical stability of bipolar disorder.
Outcome measures
| Measure |
SM-13496 20-120mg (Overall, 28 Weeks)
n=495 Participants
once daily orally
SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 28 weeks
|
SM-13496 20-120mg (Japan, 52 Weeks)
n=199 Participants
once daily orally
SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 52 weeks
|
|---|---|---|
|
Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder.
|
14 Participants
|
18 Participants
|
Adverse Events
SM-13496 20-120mg (Overall, 28 Weeks)
Serious events: 19 serious events
Other events: 250 other events
Deaths: 0 deaths
SM-13496 20-120mg (Japan, 52 Weeks)
Serious events: 12 serious events
Other events: 137 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SM-13496 20-120mg (Overall, 28 Weeks)
n=495 participants at risk
once daily orally
SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 28 weeks
|
SM-13496 20-120mg (Japan, 52 Weeks)
n=199 participants at risk
once daily orally
SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 52 weeks
|
|---|---|---|
|
General disorders
Disease progression
|
1.6%
8/495 • Number of events 8 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
1.5%
3/199 • Number of events 3 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Infections and infestations
Urinary tract infection
|
0.20%
1/495 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.00%
0/199 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.20%
1/495 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.50%
1/199 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Investigations
Blood potassium decreased
|
0.20%
1/495 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.50%
1/199 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Investigations
Glucose urine present
|
0.20%
1/495 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.50%
1/199 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Investigations
Weight decreased
|
0.20%
1/495 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.50%
1/199 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/495 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.50%
1/199 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/495 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.50%
1/199 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.20%
1/495 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.50%
1/199 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/495 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.50%
1/199 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Nervous system disorders
Akathisia
|
0.20%
1/495 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.50%
1/199 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.20%
1/495 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.50%
1/199 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Psychiatric disorders
Alcoholism
|
0.20%
1/495 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.50%
1/199 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Psychiatric disorders
Hallucination, auditory
|
0.20%
1/495 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.00%
0/199 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Psychiatric disorders
Hallucination, visual
|
0.20%
1/495 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.00%
0/199 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Psychiatric disorders
Mania
|
0.20%
1/495 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.50%
1/199 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Psychiatric disorders
Suicidal ideation
|
0.20%
1/495 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.00%
0/199 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Psychiatric disorders
Suicide attempt
|
0.61%
3/495 • Number of events 3 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
0.50%
1/199 • Number of events 1 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
Other adverse events
| Measure |
SM-13496 20-120mg (Overall, 28 Weeks)
n=495 participants at risk
once daily orally
SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 28 weeks
|
SM-13496 20-120mg (Japan, 52 Weeks)
n=199 participants at risk
once daily orally
SM-13496 (lurasidone HCl): SM-13496 20-120mg flexibly dosed up to 52 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
14/495 • Number of events 15 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
5.0%
10/199 • Number of events 11 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Gastrointestinal disorders
Nausea
|
7.1%
35/495 • Number of events 38 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
12.1%
24/199 • Number of events 25 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
17/495 • Number of events 21 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
6.5%
13/199 • Number of events 13 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
General disorders
Disease progression
|
3.2%
16/495 • Number of events 17 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
5.0%
10/199 • Number of events 11 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Infections and infestations
Nasopharyngitis
|
10.3%
51/495 • Number of events 63 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
26.6%
53/199 • Number of events 72 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Investigations
Weight increased
|
6.3%
31/495 • Number of events 31 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
8.5%
17/199 • Number of events 17 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Nervous system disorders
Akathisia
|
18.4%
91/495 • Number of events 104 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
30.2%
60/199 • Number of events 64 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Nervous system disorders
Dystonia
|
2.6%
13/495 • Number of events 15 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
5.0%
10/199 • Number of events 11 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Nervous system disorders
Headache
|
7.5%
37/495 • Number of events 46 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
8.0%
16/199 • Number of events 19 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Nervous system disorders
Parkinsonism
|
6.9%
34/495 • Number of events 43 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
7.5%
15/199 • Number of events 25 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
|
Nervous system disorders
Somnolence
|
8.3%
41/495 • Number of events 44 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
12.1%
24/199 • Number of events 24 • Adverse event data was collected for 28 weeks (outside Japan) and 52 weeks (Japan).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place