Trial Outcomes & Findings for Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex (NCT NCT01358357)
NCT ID: NCT01358357
Last Updated: 2016-09-07
Results Overview
A mood event is defined as one of the following during the double-blind phase: (1) Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) criteria for manic, mixed manic, hypomanic, or depressive episode. (2) Required treatment intervention for manic, mixed manic, hypomanic, or depressive symptoms with any antipsychotic (other than study drug), antidepressant, mood stabilizer (other than lithium or divalproex), anxiolytic agents, benzodiazepine (beyond dosage allowed for anxiety, agitation, or insomnia). (3) Psychiatric hospitalization for any bipolar mood episode. (4) Young Mania Rating Scale (YMRS) or Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 18 or Clinical Global Impression Bipolar Version, Severity of Illness (CGI BP S) score ≥ 4 at 2 consecutive assessments no more than 10 days apart. (5) Discontinuation from the study because of a mood event (as determined by the Investigator).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
965 participants
Primary outcome timeframe
28 weeks (up to 33 weeks)
Results posted on
2016-09-07
Participant Flow
There were 2 phases in this study. In Phase 1 (Open-label Stabilization Phase), there was 1 reporting group. In phase 2 (Double-blind Maintenance Phase), there were 2 reporting groups. 7 subjects completed the open-label but were not randomized DB(3- mood episode,3-not meeting the criteria for the DB phase,and 1-insufficient clinical response)
Participant milestones
| Measure |
Lurasidone 20-80 mg Flexible Dose
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
Placebo: 20-80 mg flexible dose
|
All Subjects
During the Open-label stabilization phase, subjects received flexible does of lurasidone 20 - 80 mg daily.
|
|---|---|---|---|
|
Open Label Phase
STARTED
|
0
|
0
|
965
|
|
Open Label Phase
COMPLETED
|
0
|
0
|
503
|
|
Open Label Phase
NOT COMPLETED
|
0
|
0
|
462
|
|
Double-Blind Phase
STARTED
|
246
|
250
|
0
|
|
Double-Blind Phase
COMPLETED
|
166
|
150
|
0
|
|
Double-Blind Phase
NOT COMPLETED
|
80
|
100
|
0
|
Reasons for withdrawal
| Measure |
Lurasidone 20-80 mg Flexible Dose
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
Placebo: 20-80 mg flexible dose
|
All Subjects
During the Open-label stabilization phase, subjects received flexible does of lurasidone 20 - 80 mg daily.
|
|---|---|---|---|
|
Open Label Phase
Adverse Event
|
0
|
0
|
59
|
|
Open Label Phase
Lack of Efficacy
|
0
|
0
|
107
|
|
Open Label Phase
Lost to Follow-up
|
0
|
0
|
76
|
|
Open Label Phase
Protocol Violation
|
0
|
0
|
45
|
|
Open Label Phase
Withdrawal by Subject
|
0
|
0
|
112
|
|
Open Label Phase
Did not meet criteria for DB phase
|
0
|
0
|
16
|
|
Open Label Phase
Terminated at study completion
|
0
|
0
|
5
|
|
Open Label Phase
Mood episode
|
0
|
0
|
42
|
|
Double-Blind Phase
Adverse Event
|
8
|
5
|
0
|
|
Double-Blind Phase
Lost to Follow-up
|
5
|
7
|
0
|
|
Double-Blind Phase
Protocol Violation
|
16
|
12
|
0
|
|
Double-Blind Phase
Terminated at study completion
|
2
|
0
|
0
|
|
Double-Blind Phase
Recurrence of mood event
|
48
|
64
|
0
|
|
Double-Blind Phase
Administrative
|
0
|
1
|
0
|
Baseline Characteristics
Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex
Baseline characteristics by cohort
| Measure |
Lurasidone 20-80 mg Flexible Dose
n=246 Participants
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=250 Participants
Placebo: 20-80 mg flexible dose
|
Total
n=496 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
232 Participants
n=5 Participants
|
242 Participants
n=7 Participants
|
474 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 12.43 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 12.18 • n=7 Participants
|
44.4 years
STANDARD_DEVIATION 12.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
205 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
417 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 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
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
213 Participants
n=5 Participants
|
216 Participants
n=7 Participants
|
429 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
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
30 participants
n=5 Participants
|
31 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=5 Participants
|
76 participants
n=7 Participants
|
149 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
France
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 weeks (up to 33 weeks)Population: ITT (Intent to treat) population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.
A mood event is defined as one of the following during the double-blind phase: (1) Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) criteria for manic, mixed manic, hypomanic, or depressive episode. (2) Required treatment intervention for manic, mixed manic, hypomanic, or depressive symptoms with any antipsychotic (other than study drug), antidepressant, mood stabilizer (other than lithium or divalproex), anxiolytic agents, benzodiazepine (beyond dosage allowed for anxiety, agitation, or insomnia). (3) Psychiatric hospitalization for any bipolar mood episode. (4) Young Mania Rating Scale (YMRS) or Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 18 or Clinical Global Impression Bipolar Version, Severity of Illness (CGI BP S) score ≥ 4 at 2 consecutive assessments no more than 10 days apart. (5) Discontinuation from the study because of a mood event (as determined by the Investigator).
Outcome measures
| Measure |
Lurasidone 20-80 mg Flexible Dose
n=246 Participants
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=250 Participants
Placebo: 20-80 mg flexible dose
|
|---|---|---|
|
Time to Recurrence of Mood Event During the Double Blind Treatment Phase
|
NA Days
not estimable due to an insufficient number of events
|
207 Days
Interval 207.0 to
not estimable due to an insufficient number of events
|
SECONDARY outcome
Timeframe: 28 weeks (up to 33 weeks)Population: ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.
Outcome measures
| Measure |
Lurasidone 20-80 mg Flexible Dose
n=246 Participants
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=250 Participants
Placebo: 20-80 mg flexible dose
|
|---|---|---|
|
Time to All-cause Discontinuation
|
225 Days
Interval 204.0 to 233.0
|
207 Days
Interval 207.0 to 216.0
|
SECONDARY outcome
Timeframe: 28 weeks (up to 33 weeks)Population: ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.
Outcome measures
| Measure |
Lurasidone 20-80 mg Flexible Dose
n=246 Participants
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=250 Participants
Placebo: 20-80 mg flexible dose
|
|---|---|---|
|
Time to Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode
|
NA Days
not estimable due to an insufficient number of events
|
NA Days
Interval 207.0 to
not estimable due to an insufficient number of events
|
SECONDARY outcome
Timeframe: 28 weeksPopulation: ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.
Outcome measures
| Measure |
Lurasidone 20-80 mg Flexible Dose
n=246 Participants
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=250 Participants
Placebo: 20-80 mg flexible dose
|
|---|---|---|
|
Percentage of Subjects Who Experience a Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode
|
16.7 percentage of participants
|
21.6 percentage of participants
|
SECONDARY outcome
Timeframe: Double-blind Baseline to week 28Population: ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S overall score.
The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar 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 20-80 mg Flexible Dose
n=244 Participants
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=250 Participants
Placebo: 20-80 mg flexible dose
|
|---|---|---|
|
Change From Double-blind Baseline to Week 28 (LOCF) in CGI-BP-S Overall Score
|
0.40 units on a scale
Standard Error 0.085
|
0.49 units on a scale
Standard Error 0.085
|
SECONDARY outcome
Timeframe: Double-blind Baseline to week 28Population: ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S mania score.
The CGI-BP-S mania score is a single value, clinician-rated assessment of mania illness severity and ranges from 1=Normal, not at all ill to 7=Among the most extremely ill patients. A high score is associated with greater illness severity
Outcome measures
| Measure |
Lurasidone 20-80 mg Flexible Dose
n=244 Participants
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=250 Participants
Placebo: 20-80 mg flexible dose
|
|---|---|---|
|
Change From Double -Blind Baseline to Week 28 (LOCF) in CGI-BP-S Mania Score
|
0.10 units on a scale
Standard Error 0.062
|
0.21 units on a scale
Standard Error 0.062
|
SECONDARY outcome
Timeframe: Double-blind Baseline to week 28Population: ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S depression score.
The CGI-BP-S depression score is a single value, clinician-rated assessment of depression 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 a greater illness severity.
Outcome measures
| Measure |
Lurasidone 20-80 mg Flexible Dose
n=244 Participants
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=250 Participants
Placebo: 20-80 mg flexible dose
|
|---|---|---|
|
Change From Double-blind Baseline to Week 28 (LOCF) in CGI+-BP-S Depression Score
|
0.35 units on a scale
Standard Error 0.082
|
0.42 units on a scale
Standard Error 0.081
|
SECONDARY outcome
Timeframe: Double-blind Baseline to week 28Population: ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 2 lurasidone + Li/VPA subjects did not have post-DB baseline YMRS total score.
the YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of maia.
Outcome measures
| Measure |
Lurasidone 20-80 mg Flexible Dose
n=244 Participants
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=250 Participants
Placebo: 20-80 mg flexible dose
|
|---|---|---|
|
Change From Double-blind Baseline to Week 28 (LOCF) in YMRS Total Score
|
1.0 units on a scale
Standard Error 0.43
|
1.8 units on a scale
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Double-blind Baseline to week 28Population: ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline MADRS total score.
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 of depressive symptoms.
Outcome measures
| Measure |
Lurasidone 20-80 mg Flexible Dose
n=244 Participants
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=250 Participants
Placebo: 20-80 mg flexible dose
|
|---|---|---|
|
Change From Double-blind Baseline to Week 28 (LOCF) in MADRS Total Score
|
3.0 units on a scale
Standard Error 0.57
|
3.5 units on a scale
Standard Error 0.57
|
SECONDARY outcome
Timeframe: Double-blind Baseline to week 28Population: ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 7 lurasidone + Li/VPA subjects and 7 placebo +Li/VPA subjects did not have post-DB baseline QIDS-SR16 total score.
The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms.
Outcome measures
| Measure |
Lurasidone 20-80 mg Flexible Dose
n=239 Participants
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=243 Participants
Placebo: 20-80 mg flexible dose
|
|---|---|---|
|
Change Fro Double-blind Baseline to Week 28 (LOCF) in QIDS-SR(16) Total Score
|
0.9 units on a scale
Standard Error 0.27
|
1.1 units on a scale
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Double-blind Baseline to week 28Population: ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 6 lurasidone + Li/VPA subjects and 3 placebo +Li/VPA subjects did not have post-DB baseline PANSS-P score.
The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.
Outcome measures
| Measure |
Lurasidone 20-80 mg Flexible Dose
n=240 Participants
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=247 Participants
Placebo: 20-80 mg flexible dose
|
|---|---|---|
|
Change From Double-blind Baseline to Week 28 (LOF) in PANSS Positive Symptom (PANNS-P) Subscale Score
|
0.2 units on a scale
Standard Error 0.13
|
0.3 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Double-blind Baseline to week 28Population: ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on treatment they were randomized. 63 lurasidone + Li/VPA subjects and 57 placebo +Li/VPA subjects did not have post-DB baseline SDS total score.
The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. 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.
Outcome measures
| Measure |
Lurasidone 20-80 mg Flexible Dose
n=183 Participants
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=193 Participants
Placebo: 20-80 mg flexible dose
|
|---|---|---|
|
Change From Double-blind Baseline to Week 28 (LOCF) in SDS Total Score
|
0.4 units on a scale
Standard Error 0.59
|
0.6 units on a scale
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Double-blind Baseline to week 28Population: ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 7 lurasidone + Li/VPA subjects and 7 placebo +Li/VPA subjects did not have post-DB baseline PIRS-2 total score.
The PIRS-2 is a 2-item self-report of insomnia assessed via a computer interface. Each item is scored from 0-3. The PIRS-2 total score is calculated as the sum of the 2 items. The PIRS total score ranges from 0 to 6. Higher scores are associated with greater severity of insomnia.
Outcome measures
| Measure |
Lurasidone 20-80 mg Flexible Dose
n=239 Participants
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=243 Participants
Placebo: 20-80 mg flexible dose
|
|---|---|---|
|
Change From Double-blind Baseline to Week 28 (LOCF) in PIRS-2 Total Score
|
0.4 units on a scale
Standard Error 0.10
|
0.5 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Double-blind Baseline to week 28Population: ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 12 lurasidone + Li/VPA subjects and 11 placebo +Li/VPA subjects did not have post-DB baseline Q-LES-Q-SF percent maximum possible score.
The Q-LES-Q-SF is a 16-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living. The questionnaire was developed and validated for use in depressed outpatient subjects and has eight summary scales that reflect major areas of functioning: physical health, mood, leisure time activities, social relationships, general activities, work, household duties and school/coursework. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The Q-LES-Q-SF percentage maximum possible score is calculated as 100 × (Raw Score - 14 \[Minimum Score\]) / (70 \[Maximum Score\] - 14 \[Minimum Score\]). Higher percent maximum scores indicate better quality of life.
Outcome measures
| Measure |
Lurasidone 20-80 mg Flexible Dose
n=234 Participants
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=239 Participants
Placebo: 20-80 mg flexible dose
|
|---|---|---|
|
Change From Double-blind Baseline to Week 28 (LOCF) in Q-LES-Q-SF Percent Maximum Possible Score
|
-1.70 units on a scale
Standard Error 1.022
|
-2.07 units on a scale
Standard Error 1.035
|
Adverse Events
Lurasidone 20-80 mg Flexible Dose
Serious events: 13 serious events
Other events: 81 other events
Deaths: 0 deaths
Placebo
Serious events: 11 serious events
Other events: 81 other events
Deaths: 0 deaths
All Subjects
Serious events: 41 serious events
Other events: 474 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lurasidone 20-80 mg Flexible Dose
n=246 participants at risk
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=250 participants at risk
Placebo: 20-80 mg flexible dose
|
All Subjects
n=962 participants at risk
During the open-label stabilization phase, subjects received flexible does of lurasidone 20-80 mg daily
|
|---|---|---|---|
|
Cardiac disorders
Artiral fibrillation
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Gastrointestinal disorders
Adominal pain
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
General disorders
Chest discomfort
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.41%
1/246 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.40%
1/250 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Hepatobiliary disorders
Cholecytitis acute
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.40%
1/250 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Infections and infestations
Appendicitis
|
0.41%
1/246 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.40%
1/250 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.40%
1/250 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.21%
2/962 • Number of events 2 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 2 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.40%
1/250 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.40%
1/250 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.41%
1/246 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.40%
1/250 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.40%
1/250 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral Pain Syndrome
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.40%
1/250 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Ovarian Tumour
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.40%
1/250 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Nervous system disorders
Convulsion
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.40%
1/250 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Nervous system disorders
Headache
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.40%
1/250 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Psychiatric disorders
Depression
|
0.81%
2/246 • Number of events 2 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.40%
1/250 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
1.0%
10/962 • Number of events 10 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Psychiatric disorders
Mania
|
0.81%
2/246 • Number of events 2 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
1.2%
3/250 • Number of events 3 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.52%
5/962 • Number of events 5 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Psychiatric disorders
Agitation
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.21%
2/962 • Number of events 2 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Psychiatric disorders
Suicidal Ideation
|
0.81%
2/246 • Number of events 2 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.21%
2/962 • Number of events 2 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Psychiatric disorders
Bipolar 1 Disorder
|
0.41%
1/246 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.80%
2/250 • Number of events 2 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.21%
2/962 • Number of events 2 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Psychiatric disorders
Bipolar Disorder
|
0.41%
1/246 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Psychiatric disorders
Intentional Self Injury
|
0.41%
1/246 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Psychiatric disorders
Suicide Attempt
|
0.41%
1/246 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.21%
2/962 • Number of events 2 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Psychiatric disorders
Depressive Symptom
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.21%
2/962 • Number of events 2 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Psychiatric disorders
Acute Psychosis
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Psychiatric disorders
Somatoform Disorder
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.41%
1/246 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.40%
1/250 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Vascular disorders
Hypotension
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.40%
1/250 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.41%
1/246 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Nervous system disorders
Cerebral edema
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.40%
1/250 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.10%
1/962 • Number of events 1 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
Other adverse events
| Measure |
Lurasidone 20-80 mg Flexible Dose
n=246 participants at risk
Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
|
Placebo
n=250 participants at risk
Placebo: 20-80 mg flexible dose
|
All Subjects
n=962 participants at risk
During the open-label stabilization phase, subjects received flexible does of lurasidone 20-80 mg daily
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
11.5%
111/962 • Number of events 126 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
6.1%
59/962 • Number of events 66 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
5.5%
53/962 • Number of events 56 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Gastrointestinal disorders
Fatigue
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
3.0%
29/962 • Number of events 30 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Infections and infestations
Nasopharyngitis
|
6.1%
15/246 • Number of events 17 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
4.8%
12/250 • Number of events 12 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
4.1%
39/962 • Number of events 45 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.81%
2/246 • Number of events 2 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
3.6%
9/250 • Number of events 9 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Investigations
Weight Increased
|
9.8%
24/246 • Number of events 24 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
5.2%
13/250 • Number of events 15 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/962 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
3.1%
30/962 • Number of events 30 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Nervous system disorders
Headache
|
8.5%
21/246 • Number of events 25 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
6.8%
17/250 • Number of events 21 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
9.1%
88/962 • Number of events 114 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Nervous system disorders
Tremor
|
6.1%
15/246 • Number of events 16 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
4.4%
11/250 • Number of events 12 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
4.5%
43/962 • Number of events 48 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Nervous system disorders
Somnolence
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
1.6%
4/250 • Number of events 4 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
7.2%
69/962 • Number of events 75 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Nervous system disorders
Sedation
|
0.00%
0/246 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
0.00%
0/250 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
3.5%
34/962 • Number of events 44 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Psychiatric disorders
Insomnia
|
3.7%
9/246 • Number of events 10 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
6.4%
16/250 • Number of events 25 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
8.0%
77/962 • Number of events 108 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Psychiatric disorders
Anxiety
|
1.6%
4/246 • Number of events 7 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
4.4%
11/250 • Number of events 17 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
4.3%
41/962 • Number of events 54 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
|
Nervous system disorders
Akathisia
|
3.7%
9/246 • Number of events 10 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
3.2%
8/250 • Number of events 12 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
8.3%
80/962 • Number of events 91 • For all subjects column: during open label phase (up to 20 weeks) For 7 lurasidone + Li/VPA and placebo +Li/VPA columns: during double blind phase (up to 28 weeks).
During the open label phase there were 965 subjects There were three subjects that never received study drug and therefore are not included in this section
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER