Trial Outcomes & Findings for A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients (NCT NCT00845026)
NCT ID: NCT00845026
Last Updated: 2022-11-08
Results Overview
COMPLETED
PHASE2
261 participants
Baseline through 24 weeks
2022-11-08
Participant Flow
The study included an antipsychotic drug taper/discontinuation (Study Period I) and a 3-day, single-blind placebo lead in (Study Period II). Study Period III was a 24-week active treatment phase. Participants who completed Study Period III were eligible to continue in an optional, 28-week, active treatment extension phase (Study Period IV).
Participant milestones
| Measure |
LY2140023
80 milligram (mg), oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Study Period III
STARTED
|
130
|
131
|
|
Study Period III
COMPLETED
|
35
|
59
|
|
Study Period III
NOT COMPLETED
|
95
|
72
|
|
Study Period IV
STARTED
|
28
|
50
|
|
Study Period IV
COMPLETED
|
12
|
46
|
|
Study Period IV
NOT COMPLETED
|
16
|
4
|
Reasons for withdrawal
| Measure |
LY2140023
80 milligram (mg), oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Study Period III
Adverse Event
|
23
|
19
|
|
Study Period III
Perceived lack of efficacy
|
27
|
15
|
|
Study Period III
Withdrawal by Subject
|
19
|
15
|
|
Study Period III
Entry Criteria not met
|
8
|
11
|
|
Study Period III
Lost to Follow-up
|
4
|
5
|
|
Study Period III
Protocol Violation
|
8
|
1
|
|
Study Period III
Scheduled conflict
|
3
|
1
|
|
Study Period III
Subject is moving or has moved
|
2
|
4
|
|
Study Period III
Transportation issues
|
1
|
1
|
|
Study Period IV
Adverse Event
|
4
|
0
|
|
Study Period IV
Perceived lack of efficacy
|
2
|
1
|
|
Study Period IV
Protocol Violation
|
3
|
1
|
|
Study Period IV
Lost to Follow-up
|
1
|
0
|
|
Study Period IV
Withdrawal by Subject
|
4
|
1
|
|
Study Period IV
Entry Criteria Not Met
|
1
|
0
|
|
Study Period IV
Subject is moving or has moved
|
0
|
1
|
|
Study Period IV
Scheduling conflict
|
1
|
0
|
Baseline Characteristics
A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients
Baseline characteristics by cohort
| Measure |
LY2140023
n=130 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=131 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
Total
n=261 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.65 years
STANDARD_DEVIATION 10.87 • n=5 Participants
|
39.45 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
39.05 years
STANDARD_DEVIATION 11.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
44 participants
n=5 Participants
|
39 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
65 participants
n=5 Participants
|
71 participants
n=7 Participants
|
136 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
59 participants
n=7 Participants
|
117 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
25 participants
n=5 Participants
|
23 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
41 participants
n=5 Participants
|
45 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through 24 weeksPopulation: All randomized participants.
Outcome measures
| Measure |
LY2140023
n=130 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=131 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Time to Discontinuation Due to Adverse Event (AE)
|
93.02 days
Standard Error 5.95
|
116.86 days
Standard Error 5.73
|
SECONDARY outcome
Timeframe: Baseline through 52 weeksPopulation: All randomized participants with both baseline and at least one post-baseline value.
EEG scoring by a central neurologist is done by the following definitions: E0=Normal; E1(within normal)=fewer than 3 focal abnormalities or non-epileptiform abnormalities; E2(questionably epileptiform)=3-10 focal discharges and/or 1-10 multifocal or generalized discharges; E3=(clearly epileptiform)= Sharp/slow complex, runs of epileptiform abnormalities, greater than 10 total epileptiform discharges; and E4= seizure. Decreased= maximum (max) post-baseline (PB) EEG grading\< baseline EEG grading; Increased= max PB EEG grading\> baseline EEG grading; Same=no change from baseline to max PB result.
Outcome measures
| Measure |
LY2140023
n=103 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=118 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Number of Participants With Shift From Baseline to Maximum Post-Baseline Grading in Electroencephalograms (EEGs)
Decreased
|
11 participants
|
8 participants
|
|
Number of Participants With Shift From Baseline to Maximum Post-Baseline Grading in Electroencephalograms (EEGs)
Same
|
74 participants
|
77 participants
|
|
Number of Participants With Shift From Baseline to Maximum Post-Baseline Grading in Electroencephalograms (EEGs)
Increased
|
18 participants
|
33 participants
|
SECONDARY outcome
Timeframe: Baseline through 24 weeksPopulation: All randomized participants with normal baseline measurement and at least one post-baseline measurement.
A potentially clinically significant QT interval (high) is defined as a value meeting the criteria of (\> 450 millisecond \[ms\]) at anytime during the active treatment phase, provided it does not meet the criteria at baseline. (analysis for Study Period III only)
Outcome measures
| Measure |
LY2140023
n=118 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=127 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Number of Participants With Potentially Clinically Significant Changes in QT Intervals Electrocardiograms (ECGs)
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Baseline through 52 weeksPopulation: All randomized participants.
An increase in score from baseline was considered a treatment-emergent change, unless stated otherwise. Tremor: 0 (absent) - 3 (interferes with motor function); Nystagmus: 0 (absent) - 3 (present on forward gaze); Reflexes: 0 (absent) - 4 (clonic) with normal being a score 2, decrease or increase in score was considered change. Finger-nose and gait tests: 0 (normal) - 1(abnormal); Romberg's sign: (0) absent - (1) present; Muscular strength: 0 (no contraction)-5 (full/normal resistance), decrease in score was considered change; Myoclonic jerks: 0 (absent) - 3 (frequent).
Outcome measures
| Measure |
LY2140023
n=130 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=131 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Change in Neurological Examination
Tremor
|
16 participants
|
23 participants
|
|
Number of Participants With Treatment-Emergent Change in Neurological Examination
Nystagmus
|
17 participants
|
12 participants
|
|
Number of Participants With Treatment-Emergent Change in Neurological Examination
Increased reflexes
|
9 participants
|
6 participants
|
|
Number of Participants With Treatment-Emergent Change in Neurological Examination
Decreased reflexes
|
20 participants
|
28 participants
|
|
Number of Participants With Treatment-Emergent Change in Neurological Examination
Abnormal finger-nose test
|
2 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Change in Neurological Examination
Romberg's sign
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Change in Neurological Examination
Abnormal Gait
|
4 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Change in Neurological Examination
Decreased muscle strength
|
7 participants
|
11 participants
|
|
Number of Participants With Treatment-Emergent Change in Neurological Examination
Myoclonus
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants with both baseline and at least one non-missing post-baseline value.
Least Square (LS) Mean of change from baseline in BP is from a mixed model repeated measures (MMRM) model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction.
Outcome measures
| Measure |
LY2140023
n=122 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=131 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Change From Baseline in Blood Pressure (BP) at 52 Weeks Endpoint
Supine Diastolic BP
|
2.49 millimeters of mercury (mmHg)
Standard Error 2.09
|
0.87 millimeters of mercury (mmHg)
Standard Error 1.19
|
|
Change From Baseline in Blood Pressure (BP) at 52 Weeks Endpoint
Standing Diastolic BP
|
5.57 millimeters of mercury (mmHg)
Standard Error 2.06
|
1.10 millimeters of mercury (mmHg)
Standard Error 1.21
|
|
Change From Baseline in Blood Pressure (BP) at 52 Weeks Endpoint
Supine Systolic BP
|
2.84 millimeters of mercury (mmHg)
Standard Error 2.61
|
3.47 millimeters of mercury (mmHg)
Standard Error 1.63
|
|
Change From Baseline in Blood Pressure (BP) at 52 Weeks Endpoint
Standing Systolic BP
|
4.65 millimeters of mercury (mmHg)
Standard Error 2.65
|
1.93 millimeters of mercury (mmHg)
Standard Error 1.56
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants with both baseline and at least one non-missing post-baseline value.
LS Mean of change from baseline in weight is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline weight and baseline-by-visit interaction.
Outcome measures
| Measure |
LY2140023
n=122 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=131 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Change From Baseline in Weight at 52 Weeks Endpoint
|
-4.76 kilogram (kg)
Standard Error 1.54
|
3.88 kilogram (kg)
Standard Error 1.08
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants with both baseline and at least one non-missing post-baseline value.
LS Mean of change from baseline in pulse rate is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction.
Outcome measures
| Measure |
LY2140023
n=122 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=131 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Change From Baseline in Pulse Rate at 52 Weeks Endpoint
Standing Pulse
|
-2.16 beats per minute (bpm)
Standard Error 2.16
|
-2.41 beats per minute (bpm)
Standard Error 1.30
|
|
Change From Baseline in Pulse Rate at 52 Weeks Endpoint
Supine Pulse
|
-1.62 beats per minute (bpm)
Standard Error 2.10
|
-2.44 beats per minute (bpm)
Standard Error 1.22
|
SECONDARY outcome
Timeframe: Baseline through 52 weeksPopulation: All randomized participants with a normal baseline and at least one post-baseline result.
Treatment-emergent changes in lab results on fasting glucose were analyzed using the American Diabetes Association (ADA 2001) and National Cholesterol Education Program (NCEP ATP III) guidelines. Glucose Normal to High is \<100 milligram/deciliter (mg/dL) at baseline and ≥126mg/dL post-baseline.
Outcome measures
| Measure |
LY2140023
n=71 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=78 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Number of Participants With Potentially Clinical Significant Change in Fasting Glucose Level
|
8 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Baseline through 52 weeksPopulation: All randomized participants with a normal baseline and at least one post-baseline value.
Treatment-emergent changes in lab results on lipids level were analyzed using the American Diabetes Association (ADA 2001) and National Cholesterol Education Program (NCEP ATP III) guidelines. Total cholesterol Normal to High is \<200 mg/dL at baseline and ≥240 mg/dL post-baseline. Low-density lipoprotein (LDL) cholesterol Normal to High is \<100 mg/dL at baseline and ≥160 mg/dL post-baseline. High-density lipoprotein (HDL) cholesterol Normal to Low is ≥40 mg/dL at baseline and \<40 mg/dL post-baseline. Triglycerides Normal to High is \<150 mg/dL at baseline and ≥200 mg/dL post-baseline.
Outcome measures
| Measure |
LY2140023
n=130 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=131 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Number of Participants With Potentially Clinical Significant Change in Lipids Level
Total cholesterol Normal to High (n=56, 59)
|
3 participants
|
6 participants
|
|
Number of Participants With Potentially Clinical Significant Change in Lipids Level
LDL cholesterol Normal to High (n=20, 22)
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinical Significant Change in Lipids Level
HDL cholesterol Normal to Low (n=74, 91)
|
16 participants
|
23 participants
|
|
Number of Participants With Potentially Clinical Significant Change in Lipids Level
Triglycerides Normal to High (n=58, 77)
|
7 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Baseline through 52 weeksPopulation: All randomized participants with at least one post-baseline C-SSRS value.
Columbia Suicide Rating Scale (C-SSRS): scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. There are no scores on a scale reported, rather, number of patients who reported "yes" as described above.
Outcome measures
| Measure |
LY2140023
n=122 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=131 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Number of Participants With Suicidal Behaviors and Ideations Baseline Through 52 Weeks
Suicidal ideation
|
8 participants
|
16 participants
|
|
Number of Participants With Suicidal Behaviors and Ideations Baseline Through 52 Weeks
Suicidal behavior/acts
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants with both baseline and at least one non-missing post-baseline value.
Assesses the positive and negative symptoms and general psychopathology associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. LS Mean of change from baseline is from a mixed model repeated measures (MMRM) model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline score and baseline-by-visit interaction. Higher PANSS scores mean worse symptoms.
Outcome measures
| Measure |
LY2140023
n=119 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=128 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at 52 Weeks Endpoint
|
-4.54 units on a scale
Standard Error 4.22
|
-21.47 units on a scale
Standard Error 2.51
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants with both baseline and at least one non-missing post-baseline value.
The CGI-S scale measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Mean of change from baseline is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline score and baseline-by-visit interaction. Higher CGI-S score means worse symptoms.
Outcome measures
| Measure |
LY2140023
n=121 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=131 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at 52 Weeks Endpoint
|
-0.27 units on a scale
Standard Error 0.25
|
-0.81 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants with both baseline and at least one non-missing post-baseline value.
The NSA-16 is used to rate behaviors (not psychopathology) associated with negative symptoms of schizophrenia and rates patients on 16 "anchors", each of which is rated 1 to 6. The total score is their sum and ranges from 16 to 96. Higher scores indicate greater severity of illness. LS Mean of change from baseline is from a MMRM model which includes treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline score and baseline-by-visit interaction.
Outcome measures
| Measure |
LY2140023
n=117 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=127 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Change From Baseline in 16-Item Negative Symptoms Assessment (NSA-16) Total Score at 52 Weeks Endpoint
|
-2.86 units on a scale
Standard Error 2.49
|
-7.81 units on a scale
Standard Error 1.58
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants with both baseline and at least one non-missing post-baseline value.
The MCCB assesses cognitive function in 7 domains important in schizophrenia. The MCCB overall composite score is calculated by summing age- and gender-corrected T-scores of all the domains and then standardizing the sum to a T-score, where the mean is 50 and a standard deviation is 10. A higher score indicates better performance. LS Mean of change from baseline is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline score and baseline-by-visit interaction.
Outcome measures
| Measure |
LY2140023
n=78 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=95 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB): Overall Composite T-Score at 52 Weeks Endpoint
|
5.29 units on a scale
Standard Error 1.89
|
8.19 units on a scale
Standard Error 1.27
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants with both baseline and at least one non-missing post-baseline value.
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). LS Mean of changes from baseline is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline score and baseline-by-visit interaction. Higher MADRS scores mean worse symptoms.
Outcome measures
| Measure |
LY2140023
n=117 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=128 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 52 Weeks Endpoint
|
2.72 units on a scale
Standard Error 1.40
|
-2.82 units on a scale
Standard Error 0.88
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants with both baseline and at least one non-missing post-baseline value.
The UPSA-B is a performance-based assessment of improvement in functional capacity. Patients are asked to role-play tasks in 2 areas of functioning: communication and finances. Scores are assigned for each of the 2 subscales and a provided formulae is used to calculated an UPSA-B Total Score (range = 0-100). The higher score indicates a better performance. LS mean of change from baseline is from a MMRM model which includes the effects of treatment, gender, investigator site, visit, treatment-by-visit interaction, baseline score and baseline score by-visit interaction.
Outcome measures
| Measure |
LY2140023
n=88 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=106 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Change From Baseline in University of California-San Diego (UCSD) Performance-Based Skills Assessment-B (UPSA-B) Total Score at 52 Weeks Endpoint
|
11.82 units on a scale
Standard Error 2.88
|
12.84 units on a scale
Standard Error 1.69
|
SECONDARY outcome
Timeframe: 6 and 24 weeksPopulation: All randomized participants with both baseline and at least one post-baseline PANSS values.
Response is defined as reduction ≥ 30% from baseline on PANSS Total Score (Each PANSS item transformed to a 0-6 scale first). PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on an original scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. Higher scores indicate greater severity of illness. (Analysis for Study Period III only)
Outcome measures
| Measure |
LY2140023
n=120 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=128 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Percentage of Participants With Response (Rate of Response) at 6 and 24 Weeks Endpoints
6 weeks
|
35.0 percentage of participants
|
31.3 percentage of participants
|
|
Percentage of Participants With Response (Rate of Response) at 6 and 24 Weeks Endpoints
24 weeks
|
26.7 percentage of participants
|
37.5 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All randomized participants with both baseline and at least one post-baseline PANSS values.
Remission is defined as endpoint score of mild or better (≤3) for each of the following PANSS items: delusions, conceptual disorganization, hallucinatory behavior, social withdrawal, blunted affect, lack of spontaneity and flow of conversation, mannerisms and posturing, and unusual thought content. PANSS assesses the positive and negative symptoms and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated from 1 (symptom not present) to 7 (extremely severe). The sum of the 30 items is the PANSS total score and ranges 30 - 210. (Analysis for Study Period III only)
Outcome measures
| Measure |
LY2140023
n=120 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=128 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Percentage of Participants With Remission (Rate of Remission) at Week 24 Endpoint
|
15.0 percentage of participants
|
22.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through 52 weeksPopulation: All randomized participants with non-missing relapse flag.
Relapse is defined as an increase in at least one PANSS positive item to a score\>5 and an absolute increase of ≥2 points on that item post randomization , or hospitalization for any psychiatric condition, or active suicidal ideation or suicidal behavior as captured by the C-SSRS. PANSS assesses the positive and negative symptoms and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30-210.
Outcome measures
| Measure |
LY2140023
n=130 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=131 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Percentage of Participants With Relapse (Rate of Relapse)
|
26.2 percentage of participants
|
16.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants with both baseline and at least one non-missing post-baseline value.
Measures subjective well-being for previous 7 days. 20 items covering 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Subscale scores range from 4 to 24. Total score ranges from 20 to 120. LS mean of change from baseline is from a MMRM model which includes the effects of treatment, gender, investigator site, visit, treatment-by-visit interaction, baseline score and baseline score by-visit interaction.
Outcome measures
| Measure |
LY2140023
n=106 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=120 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Change From Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) Total Score at 52 Weeks Endpoint
|
1.11 units on a scale
Standard Error 2.83
|
4.15 units on a scale
Standard Error 1.80
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants with both baseline and at least one non-missing post-baseline value.
The Personal and Social Performance (PSP) scale is a 100-point, single-item, clinician-rated scale to assess 4 domains of functioning, including personal and social relationships, socially useful activities, self care, and disturbing and aggressive behaviors. Score ranges from 1-100. The higher score indicates a better health state. LS Mean of changes from baseline is from a MMRM model which includes the effects of treatment, gender, investigator site, visit, treatment-by-visit interaction, baseline score and baseline score by-visit interaction.
Outcome measures
| Measure |
LY2140023
n=117 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=129 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Change From Baseline in Personal and Social Performance (PSP) at 52 Weeks Endpoint
|
6.47 units on a scale
Standard Error 3.13
|
10.71 units on a scale
Standard Error 1.89
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants with both baseline and at least one non-missing post-baseline value.
The EQ-5D is a quality-of-life (QoL) instrument with 2 parts: a health status profile and a visual analog scale (VAS). The profile rates patients' health state in 5 domains and each of them ranges 1-3. The outcomes on the 5 domains are mapped to an index with range 0-1. The higher score indicates a better health state. The VAS is used to indicate the patient's health status with range 0=worst and 100=best. LS means are from a MMRM model with the effects of treatment, gender, investigator site, visit, treatment-by-visit interaction, baseline score and baseline score by-visit interaction.
Outcome measures
| Measure |
LY2140023
n=130 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=131 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Change From Baseline in EuroQoL Questionnaire-5 Dimension (EQ-5D) at 52 Weeks Endpoint
Visual Analog Scale (n=107, 120)
|
4.83 units on a scale
Standard Error 4.10
|
12.84 units on a scale
Standard Error 2.43
|
|
Change From Baseline in EuroQoL Questionnaire-5 Dimension (EQ-5D) at 52 Weeks Endpoint
Index Score (n=107, 119)
|
0.03 units on a scale
Standard Error 0.05
|
0.10 units on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All randomized participants with both baseline and at least one non-missing post-baseline value.
Change in number of psychiatric visits between the 6 months prior to the active treatment phase and psychiatric visits reported during the active treatment phase was summarized. Treatment groups were compared on change using the analysis of covariance (ANCOVA) model. The model has baseline as a covariate, and investigative site, gender, and treatment as fixed effects. (Analysis for Study Period III only)
Outcome measures
| Measure |
LY2140023
n=103 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=112 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Change From Baseline in Number of Psychiatric Visits at 24 Weeks Endpoint
|
-2.60 visits
Standard Error 0.28
|
-2.95 visits
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants with both baseline and at least one non-missing post-baseline value.
The BAS rates drug induced akathisia symptoms. Akathisia is rated on a 4-point scale, with 0 being no akathisia and 3 being severe akathisia. A global clinical assessment of akathisia is then scored on a 6-point scale, with 0 being no evidence of akathisia and 5 being severe akathisia. LS mean of change from baseline in BAS global score is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline and baseline-by-visit interaction.
Outcome measures
| Measure |
LY2140023
n=122 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=131 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Change From Baseline in Barnes Akathisia Scale (BAS) Global Score at 52 Weeks Endpoint
|
-0.06 units on a scale
Standard Error 0.05
|
-0.08 units on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants with both baseline and at least one non-missing post-baseline value.
The SAS is used to measure Parkinsonian type symptoms in patients exposed to antipsychotics. The scale consists of 10 items each rated on a 5-point scale, with 0 meaning complete absence of the condition and 4 meaning the presence of the condition in extreme form. The range of possible total score is 0-40. LS Mean of change from baseline in the SAS total score is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline and baseline-by-visit interaction.
Outcome measures
| Measure |
LY2140023
n=121 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=131 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Change From Baseline in Simpson-Angus Scale (SAS) Total Score at 52 Weeks Endpoint
|
-0.87 units on a scale
Standard Error 0.26
|
-0.82 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All randomized participants with both baseline and at least one non-missing post-baseline value.
The AIMS is a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 to 10 are rated 0 - 4, with 0 being no dyskinetic movements and 4 being severe dyskinetic movements. Items 11 and 12 are yes/no questions regarding the dental condition of a subject. The total score is the sum of items 1-7 and ranges from 0-28. LS means of change from baseline in the AIMS total score is from a MMRM model which includes the effects of treatment, gender, investigative site, visit, treatment-by-visit interaction, baseline and baseline-by-visit interaction.
Outcome measures
| Measure |
LY2140023
n=122 Participants
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Standard-of-Care (SOC)
n=131 Participants
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at 52 Weeks Endpoint
|
0.13 units on a scale
Standard Error 0.29
|
-0.23 units on a scale
Standard Error 0.18
|
Adverse Events
LY2140023
Olanzapine
Aripiprazole
Risperidone
Serious adverse events
| Measure |
LY2140023
n=130 participants at risk
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Olanzapine
n=48 participants at risk
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
|
Aripiprazole
n=48 participants at risk
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
|
Risperidone
n=35 participants at risk
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Gastrointestinal disorders
Vomiting
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Infections and infestations
Pneumonia
|
1.5%
2/130 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Infections and infestations
Respiratory tract infection viral
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Nervous system disorders
Headache
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Nervous system disorders
Paraesthesia
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/130 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Psychiatric disorders
Agitation
|
1.5%
2/130 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Psychiatric disorders
Anxiety
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Psychiatric disorders
Depression
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/130 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Psychiatric disorders
Insomnia
|
1.5%
2/130 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Psychiatric disorders
Psychotic behaviour
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Psychiatric disorders
Psychotic disorder
|
2.3%
3/130 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
2.9%
1/35 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
|
Psychiatric disorders
Schizophrenia
|
6.9%
9/130 • Number of events 9 • 1 year
according to clinicaltrials.gov
|
6.2%
3/48 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
8.3%
4/48 • Number of events 4 • 1 year
according to clinicaltrials.gov
|
2.9%
1/35 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Psychiatric disorders
Suicidal ideation
|
1.5%
2/130 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
Other adverse events
| Measure |
LY2140023
n=130 participants at risk
80 mg, oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.
|
Olanzapine
n=48 participants at risk
olanzapine: 10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).
|
Aripiprazole
n=48 participants at risk
aripiprazole: 10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).
|
Risperidone
n=35 participants at risk
risperidone: 2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.1%
4/130 • Number of events 4 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
8.6%
3/35 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
|
Gastrointestinal disorders
Dry mouth
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
6.2%
3/48 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
4.2%
2/48 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
8/130 • Number of events 8 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Gastrointestinal disorders
Nausea
|
8.5%
11/130 • Number of events 14 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
6.2%
3/48 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
2.9%
1/35 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
|
Gastrointestinal disorders
Vomiting
|
10.8%
14/130 • Number of events 19 • 1 year
according to clinicaltrials.gov
|
4.2%
2/48 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
5.7%
2/35 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
|
General disorders
Fatigue
|
2.3%
3/130 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
6.2%
3/48 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
7/130 • Number of events 10 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
4.2%
2/48 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
2.9%
1/35 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/130 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
6.2%
3/48 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
2.9%
1/35 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
|
Investigations
Blood creatine phosphokinase increased
|
9.2%
12/130 • Number of events 14 • 1 year
according to clinicaltrials.gov
|
10.4%
5/48 • Number of events 6 • 1 year
according to clinicaltrials.gov
|
14.6%
7/48 • Number of events 9 • 1 year
according to clinicaltrials.gov
|
14.3%
5/35 • Number of events 7 • 1 year
according to clinicaltrials.gov
|
|
Investigations
Blood triglycerides increased
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
8.3%
4/48 • Number of events 5 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Investigations
Weight increased
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
12.5%
6/48 • Number of events 6 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
8.6%
3/35 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/130 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
5.7%
2/35 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
5/130 • Number of events 5 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
5.7%
2/35 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
4.2%
2/48 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
6.2%
3/48 • Number of events 5 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Nervous system disorders
Akathisia
|
1.5%
2/130 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
4.2%
2/48 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
10.4%
5/48 • Number of events 5 • 1 year
according to clinicaltrials.gov
|
8.6%
3/35 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
|
Nervous system disorders
Extrapyramidal disorder
|
2.3%
3/130 • Number of events 5 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
6.2%
3/48 • Number of events 4 • 1 year
according to clinicaltrials.gov
|
5.7%
2/35 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
|
Nervous system disorders
Headache
|
13.1%
17/130 • Number of events 23 • 1 year
according to clinicaltrials.gov
|
14.6%
7/48 • Number of events 8 • 1 year
according to clinicaltrials.gov
|
4.2%
2/48 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
8.6%
3/35 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
|
Nervous system disorders
Lethargy
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
6.2%
3/48 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
|
Nervous system disorders
Somnolence
|
2.3%
3/130 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
6.2%
3/48 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
8.6%
3/35 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
|
Nervous system disorders
Tremor
|
3.8%
5/130 • Number of events 7 • 1 year
according to clinicaltrials.gov
|
10.4%
5/48 • Number of events 8 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
5.7%
2/35 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
|
Psychiatric disorders
Agitation
|
7.7%
10/130 • Number of events 12 • 1 year
according to clinicaltrials.gov
|
2.1%
1/48 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
2.9%
1/35 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
|
Psychiatric disorders
Anxiety
|
16.2%
21/130 • Number of events 28 • 1 year
according to clinicaltrials.gov
|
10.4%
5/48 • Number of events 6 • 1 year
according to clinicaltrials.gov
|
10.4%
5/48 • Number of events 8 • 1 year
according to clinicaltrials.gov
|
11.4%
4/35 • Number of events 4 • 1 year
according to clinicaltrials.gov
|
|
Psychiatric disorders
Insomnia
|
16.2%
21/130 • Number of events 23 • 1 year
according to clinicaltrials.gov
|
6.2%
3/48 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
12.5%
6/48 • Number of events 8 • 1 year
according to clinicaltrials.gov
|
5.7%
2/35 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
|
Psychiatric disorders
Psychotic disorder
|
0.77%
1/130 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
8.3%
4/48 • Number of events 5 • 1 year
according to clinicaltrials.gov
|
6.2%
3/48 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
2.9%
1/35 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
|
Reproductive system and breast disorders
Amenorrhoea
|
2.2%
1/45 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
7.7%
1/13 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
0.00%
0/21 • 1 year
according to clinicaltrials.gov
|
10.0%
1/10 • Number of events 1 • 1 year
according to clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
5/130 • Number of events 6 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
4.2%
2/48 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
5.7%
2/35 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/130 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
5.7%
2/35 • Number of events 2 • 1 year
according to clinicaltrials.gov
|
|
Vascular disorders
Hypertension
|
2.3%
3/130 • Number of events 3 • 1 year
according to clinicaltrials.gov
|
0.00%
0/48 • 1 year
according to clinicaltrials.gov
|
6.2%
3/48 • Number of events 4 • 1 year
according to clinicaltrials.gov
|
0.00%
0/35 • 1 year
according to clinicaltrials.gov
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60