Trial Outcomes & Findings for A Study of LY2140023 in Patients With Schizophrenia (NCT NCT01307800)
NCT ID: NCT01307800
Last Updated: 2022-10-18
Results Overview
The PANSS scale assessed participants (pts) for positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consisted of 30 items. Each item was rated from 1 (absence of symptoms) to 7 (symptoms extremely severe). The sum of the 30 items was defined as the PANSS total score and ranged from 30 to 210. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, gender, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
TERMINATED
PHASE3
567 participants
Baseline, Week 6
2022-10-18
Participant Flow
Prior to randomization, participants completed a 1-week placebo lead-in period, during which time placebo tablets were administered orally, twice daily (BID). The Participant Flow and results are based on participants, post-randomization.
Participant milestones
| Measure |
80 mg LY2140023, BID
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
111
|
110
|
118
|
228
|
|
Overall Study
Received Treatment (Rec'd Tx)
|
111
|
110
|
118
|
228
|
|
Overall Study
Rec'd Tx, Not a Placebo (PL) Responder
|
102
|
103
|
112
|
217
|
|
Overall Study
COMPLETED
|
57
|
45
|
60
|
118
|
|
Overall Study
NOT COMPLETED
|
54
|
65
|
58
|
110
|
Reasons for withdrawal
| Measure |
80 mg LY2140023, BID
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
8
|
10
|
14
|
|
Overall Study
Entry Criteria Not Met
|
0
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
2
|
8
|
|
Overall Study
Perceived Lack of Efficacy
|
24
|
23
|
20
|
33
|
|
Overall Study
Protocol Violation
|
0
|
3
|
4
|
5
|
|
Overall Study
Schedule Conflict Prevented Continuation
|
0
|
3
|
1
|
2
|
|
Overall Study
Sponsor Decision
|
6
|
9
|
12
|
28
|
|
Overall Study
Withdrawal by Subject
|
10
|
11
|
8
|
15
|
|
Overall Study
Participant Moved
|
0
|
2
|
1
|
3
|
Baseline Characteristics
A Study of LY2140023 in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
80 mg LY2140023, BID
n=111 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=110 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=118 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=228 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
Total
n=567 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
57 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
285 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
256 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
Mexico
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
9 participants
n=4 Participants
|
19 participants
n=21 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
9 participants
n=4 Participants
|
21 participants
n=21 Participants
|
|
Region of Enrollment
Russian Federation
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
17 participants
n=5 Participants
|
29 participants
n=4 Participants
|
74 participants
n=21 Participants
|
|
Region of Enrollment
Ukraine
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
88 participants
n=5 Participants
|
88 participants
n=7 Participants
|
89 participants
n=5 Participants
|
178 participants
n=4 Participants
|
443 participants
n=21 Participants
|
|
Age, Continuous
|
41.15 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
40.23 years
STANDARD_DEVIATION 11.39 • n=7 Participants
|
39.80 years
STANDARD_DEVIATION 10.45 • n=5 Participants
|
40.83 years
STANDARD_DEVIATION 11.19 • n=4 Participants
|
40.56 years
STANDARD_DEVIATION 11.11 • n=21 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
157 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
162 Participants
n=4 Participants
|
410 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
481 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: Pts in efficacy-evaluable intent-to-treat (EE-ITT) population (received at least 1 dose of study drug and not placebo lead-in responders) who had baseline and at least 1 post-baseline PANSS total score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responder had ≥25% PANSS total score improvement in lead-in period.
The PANSS scale assessed participants (pts) for positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consisted of 30 items. Each item was rated from 1 (absence of symptoms) to 7 (symptoms extremely severe). The sum of the 30 items was defined as the PANSS total score and ranged from 30 to 210. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, gender, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=91 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=96 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=106 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=206 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score
|
-3.7 units on a scale
Standard Error 2.1
|
-4.8 units on a scale
Standard Error 2.3
|
-5.0 units on a scale
Standard Error 2.0
|
-7.8 units on a scale
Standard Error 1.6
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: EE-ITT participants (see Outcome Measure 1 for population definition) in the predefined subpopulation who had a baseline and at least 1 post-baseline PANSS total score. The predefined subpopulation excluded non-Hispanic whites (self-reported) who had A/A genotype at the serotonin 2A receptor (HTR2A) single nucleotide polymorphism (SNP), rs7330461.
The PANSS scale assessed participants for positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consisted of 30 items. Each item was rated from 1 (absence of symptoms) to 7 (symptoms extremely severe). The sum of the 30 items was defined as the PANSS total score and ranged from 30 to 210. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, and gender, as well as the continuous fixed covariates of baseline score, and baseline score-by-visit interaction.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=75 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=86 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=90 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=168 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score in a Predefined Subpopulation of Schizophrenia Participants
|
-3.4 units on a scale
Standard Error 2.2
|
-4.3 units on a scale
Standard Error 2.2
|
-4.8 units on a scale
Standard Error 2.0
|
-7.7 units on a scale
Standard Error 1.5
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline PSP score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had a ≥25% PANSS total score improvement in the lead-in period.
The PSP scale was a 100-point, single item scale that assessed 4 domains of functioning (personal and social relationships, socially useful activities, self-care, and disturbing and aggressive behaviors). PSP scores ranged from 1 (risk of death) to 100 (excellent functioning) in all 4 domain areas. A higher score indicated a better health state. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, gender, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=67 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=67 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=75 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=149 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline in the Personal and Social Performance (PSP) Score
|
7.9 units on a scale
Standard Error 1.4
|
9.6 units on a scale
Standard Error 1.6
|
7.1 units on a scale
Standard Error 1.4
|
8.4 units on a scale
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: EE-ITT participants (see Outcome Measure 1 for population definition) in the predefined subpopulation who had a baseline and at least 1 post-baseline PSP score. The predefined subpopulation excluded non-Hispanic whites (self-reported) who had A/A genotype at the serotonin 2A receptor (HTR2A) single nucleotide polymorphism (SNP), rs7330461.
The PSP scale was a 100-point, single item scale that assessed 4 domains of functioning (personal and social relationships, socially useful activities, self-care, and disturbing and aggressive behaviors). PSP scores ranged from 1 (risk of death) to 100 (excellent functioning) in all 4 domain areas. A higher score indicated a better health state. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, and gender, as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=55 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=61 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=64 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=118 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline in the Personal and Social Performance (PSP) Score in a Predefined Subpopulation
|
6.7 units on a scale
Standard Error 1.4
|
8.6 units on a scale
Standard Error 1.4
|
6.3 units on a scale
Standard Error 1.3
|
7.1 units on a scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Female participants (pts) in EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had baseline and at least 1 post-baseline PANSS total score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had ≥25% PANSS total score improvement in lead-in period.
The PANSS scale assessed participants for positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consisted of 30 items. Each item was rated from 1 (absence of symptoms) to 7 (symptoms extremely severe). The sum of the 30 items was defined as the PANSS total score and ranged from 30 to 210. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=29 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=23 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=29 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=56 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score in Females
|
0.8 units on a scale
Standard Error 3.8
|
0.0 units on a scale
Standard Error 4.3
|
-4.5 units on a scale
Standard Error 3.5
|
-8.7 units on a scale
Standard Error 2.7
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline PANSS subscore. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had a ≥25% PANSS total score improvement in the lead-in period.
PANSS subscales included the positive, negative, and general psychopathology subscales. PANSS positive and negative subscales assessed participants for 7 symptoms (positive or negative) associated with schizophrenia. Each item was rated from 1 (absence of symptoms) to 7 (symptoms extremely severe). Scores for both subscales ranged from 7 to 49. PANSS general psychopathology subscale assessed participants for 16 items of general psychopathology associated with schizophrenia. Each item was rated from 1 (absence of symptom) to 7 (symptom extremely severe). General psychopathology scores ranged from 16 to 112. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, gender, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=91 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=96 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=106 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=206 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Subscores
PANSS Negative Subscore
|
-0.5 units on a scale
Standard Error 0.7
|
0.2 units on a scale
Standard Error 0.7
|
-0.6 units on a scale
Standard Error 0.6
|
-1.1 units on a scale
Standard Error 0.5
|
|
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Subscores
PANSS General Psychopathology Subscore
|
-1.9 units on a scale
Standard Error 1.1
|
-2.8 units on a scale
Standard Error 1.2
|
-2.7 units on a scale
Standard Error 1.1
|
-4.2 units on a scale
Standard Error 0.8
|
|
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Subscores
PANSS Positive Subscore
|
-1.2 units on a scale
Standard Error 0.7
|
-2.3 units on a scale
Standard Error 0.7
|
-2.0 units on a scale
Standard Error 0.6
|
-2.8 units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants in the EE-ITT population (participants who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline PANSS total score. Placebo lead-in responders had a ≥25% PANSS total score improvement in the lead-in period; Last observation carried forward (LOCF).
Response during the treatment period was defined as a ≥30% decrease from baseline in Positive and Negative Syndrome Scale (PANSS) total score. The PANSS scale assessed participants for positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consisted of 30 items. Each item was rated from 1 (absence of symptoms) to 7 (symptoms extremely severe). The sum of the 30 items was defined as the PANSS total score and ranged from 30 to 210.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=91 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=97 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=107 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=206 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Percentage of Participants Who Are Responders
|
3.3 percentage of participants
|
7.2 percentage of participants
|
7.5 percentage of participants
|
8.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 6Population: Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline PANSS total score. Number of pts censored: 80 mg LY2140023, BID = 88 pts, 40 mg LY2140023, BID = 90 pts, 10 mg LY2140023, BID = 99 pts, and placebo = 189 pts.
Time to response is the number of days from randomization until a ≥30% decrease from lead-in baseline in Positive and Negative Syndrome Scale (PANSS) total score. Participants who did not have a response were censored. The PANSS scale assessed participants for positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consisted of 30 items. Each item was rated from 1 (absence of symptoms) to 7 (symptoms extremely severe). The sum of the 30 items was defined as the PANSS total score and ranged from 30 to 210.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=91 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=97 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=107 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=206 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Time to Response
|
NA days
The median (full range) for time to response was not calculable because an insufficient number of participants reached the response event by the final time point (Week 6).
|
NA days
The median (full range) for time to response was not calculable because an insufficient number of participants reached the response event by the final time point (Week 6).
|
NA days
The median (full range) for time to response was not calculable because an insufficient number of participants reached the response event by the final time point (Week 6).
|
NA days
The median (full range) for time to response was not calculable because an insufficient number of participants reached the response event by the final time point (Week 6).
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline CGI-S score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had a ≥25% PANSS total score improvement in the lead-in period.
The CGI-S was a single item scale that measured severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, gender, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=97 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=100 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=109 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=213 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Scale
|
-0.5 units on a scale
Standard Error 0.1
|
-0.6 units on a scale
Standard Error 0.1
|
-0.5 units on a scale
Standard Error 0.1
|
-0.6 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had baseline and at least 1 post-baseline NSA-16 total score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had ≥25% PANSS total score improvement in the lead-in period.
The NSA-16 scale was used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale contained 16 items and each item was rated from 1 (normal behavior) to 6 (extreme, abnormal behavior). The sum of the 16 items was defined as the NSA-16 total score and ranged from 16 to 96. Higher scores indicated a greater severity of illness. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, gender, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=67 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=67 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=74 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=149 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline in the 16-Item Negative Symptoms Assessment (NSA-16) Total Score
|
-5.5 units on a scale
Standard Error 1.4
|
-7.1 units on a scale
Standard Error 1.5
|
-6.3 units on a scale
Standard Error 1.3
|
-5.4 units on a scale
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants in the EE-ITT population (participants who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline EQ-5D VAS health state score. Excluded were participants with missing predefined subpopulation data; Last observation carried forward (LOCF).
The EQ-5D was a generic, multidimensional, health-related, quality-of-life instrument. The overall health state score was self-reported using a visual analogue scale (VAS) from 0 (worst imaginable health state) to 100 (best imaginable health state). The least squares (LS) mean was estimated using an analysis of covariance (ANCOVA) model that included terms for treatment, pooled investigative site, gender, baseline score and predefined subpopulation ('yes/no').
Outcome measures
| Measure |
80 mg LY2140023, BID
n=84 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=76 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=96 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=180 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline on the European Quality of Life-5 Dimension (EQ-5D) Questionnaire
|
6.0 units on a scale
Standard Error 2.5
|
3.5 units on a scale
Standard Error 2.8
|
8.2 units on a scale
Standard Error 2.4
|
6.1 units on a scale
Standard Error 2.0
|
SECONDARY outcome
Timeframe: Baseline and Week (Wk) 6Population: Participants (pts) in EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline S-RUM score for ER/facility visits or outpatient visits. Placebo lead-in responders had a ≥25% PANSS total score improvement in the lead-in period; Last observation carried forward (LOCF).
The S-RUM was a 31-item questionnaire to assess the participant's occupation (work and home), living arrangements, encounters with law enforcement, victimization, ER visits, and outpatient medical visits for a specified period of time. Item 1 asked about the number of ER or equivalent facility visits a participant had for psychiatric (psych) illness during the last year \[baseline (BL) assessment\] or since the last assessment (post-baseline assessment). Item 2 asked about the number of ER or equivalent facility visits a participant had for non-psychiatric (non-psych) illness or injury during the last year (BL assessment) or since the last assessment (post-BL assessment). Item 5 asked about the number of outpatient visits to other physicians (not psychiatrists or dentists) a participant had during the last year (BL assessment) or since the last assessment (post-BL assessment).
Outcome measures
| Measure |
80 mg LY2140023, BID
n=90 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=82 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=102 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=184 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline on Schizophrenia Resource Utilization Module (S-RUM): Emergency Room (ER) Visits and Outpatient Visits
ER/Facility (Psych), BL
|
1.4 visits
Standard Deviation 1.8
|
1.1 visits
Standard Deviation 1.6
|
1.1 visits
Standard Deviation 1.8
|
1.3 visits
Standard Deviation 2.4
|
|
Change From Baseline on Schizophrenia Resource Utilization Module (S-RUM): Emergency Room (ER) Visits and Outpatient Visits
ER/Facility (Psych), Wk 6
|
0.1 visits
Standard Deviation 0.6
|
0.0 visits
Standard Deviation 0.2
|
0.1 visits
Standard Deviation 0.5
|
0.0 visits
Standard Deviation 0.3
|
|
Change From Baseline on Schizophrenia Resource Utilization Module (S-RUM): Emergency Room (ER) Visits and Outpatient Visits
ER/Facility (Non-Psych), BL
|
0.4 visits
Standard Deviation 0.9
|
0.3 visits
Standard Deviation 0.8
|
0.5 visits
Standard Deviation 1.3
|
0.4 visits
Standard Deviation 0.9
|
|
Change From Baseline on Schizophrenia Resource Utilization Module (S-RUM): Emergency Room (ER) Visits and Outpatient Visits
ER/Facility (Non-Psych), Wk 6
|
0.0 visits
Standard Deviation 0.2
|
0.0 visits
Standard Deviation 0.1
|
0.0 visits
Standard Deviation 0.2
|
0.0 visits
Standard Deviation 0.3
|
|
Change From Baseline on Schizophrenia Resource Utilization Module (S-RUM): Emergency Room (ER) Visits and Outpatient Visits
Outpatient, BL
|
2.3 visits
Standard Deviation 10.0
|
1.6 visits
Standard Deviation 3.2
|
1.6 visits
Standard Deviation 3.3
|
1.6 visits
Standard Deviation 2.9
|
|
Change From Baseline on Schizophrenia Resource Utilization Module (S-RUM): Emergency Room (ER) Visits and Outpatient Visits
Outpatient, Wk 6
|
0.1 visits
Standard Deviation 0.7
|
0.1 visits
Standard Deviation 0.3
|
0.1 visits
Standard Deviation 0.5
|
0.2 visits
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Participants (pts) in EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline S-RUM score for sessions with a psychiatrist. Placebo lead-in responders had a ≥25% PANSS total score improvement in the lead-in period; Last observation carried forward (LOCF).
The S-RUM was a 31-item questionnaire to assess the participant's occupation (work and home), living arrangements, encounters with law enforcement, victimization, emergency room (ER) visits, and outpatient medical visits for a specified period of time. Item 4 asked about the number of sessions with a psychiatrist a participant had, that were not part of this study, during the last year (baseline assessment) or since the last assessment (post-baseline assessment).
Outcome measures
| Measure |
80 mg LY2140023, BID
n=90 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=82 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=102 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=184 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline on Schizophrenia Resource Utilization Module (S-RUM): Sessions With a Psychiatrist
Sessions at Baseline
|
6.7 sessions
Standard Deviation 6.8
|
7.1 sessions
Standard Deviation 7.4
|
7.0 sessions
Standard Deviation 8.3
|
6.7 sessions
Standard Deviation 9.4
|
|
Change From Baseline on Schizophrenia Resource Utilization Module (S-RUM): Sessions With a Psychiatrist
Sessions at Week 6
|
0.6 sessions
Standard Deviation 2.5
|
0.5 sessions
Standard Deviation 2.1
|
0.6 sessions
Standard Deviation 2.6
|
0.2 sessions
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants (pts) in the EE-ITT population (pts who received at least 1 dose of study drug and were not placebo lead-in responders) who had a baseline and at least 1 post-baseline SWN-S total score. Excluded were pts with missing predefined subpopulation data. Placebo lead-in responders had ≥25% PANSS total score improvement in the lead-in period.
The SWN-S was a self-rated scale that measured subjective well-being for the previous 7 days. The SWN-S consisted of 20 items each rated using a 6-point scale from 1 (not at all) to 6 (very much). The sum of the 20 items was defined as the SWN-S total score and ranged from 20 to 120, with higher scores indicating better subjective well-being. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, gender, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=66 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=65 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=74 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=148 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline on Subjective Well-Being Under Neuroleptic Treatment Scale - Short Form (SWN-S) Total Score
|
1.2 units on a scale
Standard Error 2.3
|
8.6 units on a scale
Standard Error 2.5
|
5.9 units on a scale
Standard Error 2.2
|
6.8 units on a scale
Standard Error 1.7
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants in the ITT population (participants who received at least 1 dose of study drug according to the treatment group to which they were randomized) who had a baseline and at least 1 post-baseline BAS global score. Excluded were participants with missing predefined subpopulation data.
The BAS was a 4-item instrument that evaluated akathisia associated with the use of antipsychotic medications. Item 4 was the Global Clinical Assessment (global score) and was rated from 0 (absent) to 5 (severe). The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, gender, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=106 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=107 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=115 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=224 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline in Barnes Akathisia Scale (BAS) Global Score
|
-0.01 units on a scale
Standard Error 0.04
|
-0.4 units on a scale
Standard Error 0.04
|
0.0 units on a scale
Standard Error 0.04
|
0.01 units on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants in the ITT population (participants who received at least 1 dose of study drug according to the treatment group to which they were randomized) who had a baseline and at least 1 post-baseline SAS total score. Excluded were participants with missing predefined subpopulation data.
The SAS was used to measure Parkinsonian-type symptoms in participants exposed to antipsychotics. The scale consisted of 10 items and each item was rated on a 5-point scale from 0 (complete absence of the condition) to 4 (the presence of the condition in extreme form). The sum of the 10 items was defined as the SAS total score and ranged from 0 to 40. Higher scores indicated a greater severity of illness. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, gender, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=105 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=107 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=115 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=224 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline in Simpson-Angus Scale (SAS) Total Score
|
-0.06 units on a scale
Standard Error 0.11
|
-0.18 units on a scale
Standard Error 0.12
|
0.13 units on a scale
Standard Error 0.11
|
-0.11 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants in the ITT population (participants who received at least 1 dose of study drug according to the treatment group to which they were randomized) who had a baseline and at least 1 post-baseline AIMS 1-7 total score. Excluded were participants with missing predefined subpopulation data.
The AIMS was a 12-item scale designed to record the occurrence of abnormal involuntary (dyskinetic) movements. Items 1 to 10 were rated on a 5-point scale from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 11 and 12 were 'yes/no' questions regarding the dental condition of a participant. The sum of Items 1 through 7 was defined as the AIMS 1-7 total score and ranged from 0 to 28. Higher scores indicated a greater severity of illness. The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, gender, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=106 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=107 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=115 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=223 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline in Abnormal Involuntary Movement Scales (AIMS) 1-7 Total Score
|
-0.09 units on a scale
Standard Error 0.12
|
-0.01 units on a scale
Standard Error 0.13
|
0.03 units on a scale
Standard Error 0.11
|
-0.10 units on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline up to Week 6Population: Participants in the ITT population (participants who received at least 1 dose of study drug according to the treatment group to which they were randomized) who had a baseline and at least 1 post-baseline C-SSRS assessment.
The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Suicidal behavior: a "yes" answer to any 1 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 1 of 5 suicidal ideation questions (wish to be dead, and 4 different categories of active suicidal ideation). The percentage of participants with treatment-emergent suicidal ideation or behavior (with a change from baseline in C-SSRS) was calculated as the number of participants with an increase in suicidal behavior or ideation over lead-in baseline, divided by the total number of participants multiplied by 100.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=106 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=108 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=116 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=224 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Percentage of Participants With a Change From Baseline in Suicidal Behaviors and Ideations Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Treatment-Emergent Suicidal Ideation
|
2.8 percentage of participants
|
5.6 percentage of participants
|
6.0 percentage of participants
|
4.0 percentage of participants
|
|
Percentage of Participants With a Change From Baseline in Suicidal Behaviors and Ideations Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Treatment-Emergent Suicidal Behavior
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.9 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization up to Week 6Population: All randomized participants.
The reasons for study discontinuation are located in the Participant Flow.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=111 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=110 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=118 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=228 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued
|
54 participants
|
65 participants
|
58 participants
|
110 participants
|
SECONDARY outcome
Timeframe: Randomization up to Week 6Population: Participants (pts) in the ITT population (pts who received at least 1 dose of study drug according to the treatment group to which they were randomized). Number of pts censored: 80 mg LY2140023, BID = 57 pts, 40 mg LY2140023, BID = 45 pts, 10 mg LY2140023, BID = 60 pts, and placebo = 118 pts.
The time to discontinuation, due to any reason, was defined as the total number of days between the randomization date and discontinuation date. Participants who completed the study period were censored. The time to discontinuation was analyzed using Kaplan-Meier estimated survival curves.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=111 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=110 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=118 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=228 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Time to Discontinuation
|
NA days
The median (full range) was not calculable because an insufficient number of participants reached the event by the final time point (Week 6).
|
NA days
The median (full range) was not calculated because an insufficient number of participants in all treatment arms reached the event by the final time point (Week 6).
|
NA days
The median (full range) was not calculable because an insufficient number of participants reached the event by the final time point (Week 6).
|
NA days
The median (full range) was not calculable because an insufficient number of participants reached the event by the final time point (Week 6).
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants in the ITT population (participants who received at least 1 dose of study drug according to the treatment group to which they were randomized) who had a baseline and at least 1 post-baseline prolactin lab result; Last observation carried forward (LOCF).
Outcome measures
| Measure |
80 mg LY2140023, BID
n=101 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=99 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=105 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=208 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline in Prolactin
|
0.6 micrograms per Liter (mcg/L)
Standard Deviation 15.4
|
-0.1 micrograms per Liter (mcg/L)
Standard Deviation 15.1
|
1.9 micrograms per Liter (mcg/L)
Standard Deviation 12.2
|
-0.8 micrograms per Liter (mcg/L)
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Participants in the ITT population (participants who received at least 1 dose of study drug according to the treatment group to which they were randomized) who had their weight measured at baseline and at least 1 post-baseline visit. Excluded were participants with missing predefined subpopulation data.
The least squares (LS) mean was estimated using a mixed-effects model with repeated measures (MMRM) that included the fixed, categorical effects of treatment, pooled investigative site, visit, treatment-by-visit interaction, gender, and predefined subpopulation ('yes/no'), as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=105 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=107 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=115 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=223 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Change From Baseline in Weight
|
0.6 kilograms (kg)
Standard Error 0.4
|
0.6 kilograms (kg)
Standard Error 0.4
|
0.2 kilograms (kg)
Standard Error 0.4
|
0.5 kilograms (kg)
Standard Error 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Last dose (either early discontinuation or Week 6) through 30-day follow-up periodPopulation: Participants who received at least 1 dose of study drug according to the treatment group to which they were randomized.
SAEs occurring AFTER a participant's last dose of study drug were to be followed for 30 days, regardless of the investigator's opinion of causation. An SAE was any adverse event (AE) that resulted in death, an initial or prolonged inpatient hospitalization (other than that required by protocol), a life-threatening experience with the immediate risk of dying, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, the occurrence of a seizure or seizure-like event, or an event considered significant by the investigator for any reason. SAEs were reported per Medical Dictionary for Regulatory Activities (MedDRA version 15.1) preferred terms. A summary of serious and all other non-serious AEs reported from Baseline up to Week 6 is located in the Reported Adverse Events module.
Outcome measures
| Measure |
80 mg LY2140023, BID
n=111 Participants
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=110 Participants
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=118 Participants
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=228 Participants
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Serious Adverse Events (SAEs) Which Occurred During 30 Days After Last Dose of Study Drug
Irritability
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Serious Adverse Events (SAEs) Which Occurred During 30 Days After Last Dose of Study Drug
Suicidal ideation
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Serious Adverse Events (SAEs) Which Occurred During 30 Days After Last Dose of Study Drug
Homicidal ideation
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Serious Adverse Events (SAEs) Which Occurred During 30 Days After Last Dose of Study Drug
Acute myocardial infarction (resulted in death)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Serious Adverse Events (SAEs) Which Occurred During 30 Days After Last Dose of Study Drug
Schizophrenia
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
Adverse Events
80 mg LY2140023, BID
40 mg LY2140023, BID
10 mg LY2140023, BID
Placebo
Serious adverse events
| Measure |
80 mg LY2140023, BID
n=111 participants at risk
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=110 participants at risk
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=118 participants at risk
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=228 participants at risk
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/111 • Baseline to 30 Days After Last Dose of Study Drug
|
0.91%
1/110 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/118 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/228 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/111 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/110 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/118 • Baseline to 30 Days After Last Dose of Study Drug
|
0.44%
1/228 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Infections and infestations
Bronchitis
|
0.00%
0/111 • Baseline to 30 Days After Last Dose of Study Drug
|
0.91%
1/110 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/118 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/228 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/111 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/110 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/118 • Baseline to 30 Days After Last Dose of Study Drug
|
0.44%
1/228 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Nervous system disorders
Stupor
|
0.00%
0/111 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/110 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/118 • Baseline to 30 Days After Last Dose of Study Drug
|
0.44%
1/228 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Nervous system disorders
Syncope
|
0.00%
0/111 • Baseline to 30 Days After Last Dose of Study Drug
|
0.91%
1/110 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/118 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/228 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Psychiatric disorders
Delusion
|
0.00%
0/111 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/110 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/118 • Baseline to 30 Days After Last Dose of Study Drug
|
0.44%
1/228 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/111 • Baseline to 30 Days After Last Dose of Study Drug
|
1.8%
2/110 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
0.85%
1/118 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
1.3%
3/228 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Psychiatric disorders
Schizophrenia
|
0.90%
1/111 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
0.91%
1/110 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
2.5%
3/118 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
0.88%
2/228 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Psychiatric disorders
Suicidal behaviour
|
0.00%
0/111 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/110 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/118 • Baseline to 30 Days After Last Dose of Study Drug
|
0.44%
1/228 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Psychiatric disorders
Suicidal ideation
|
1.8%
2/111 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/110 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/118 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/228 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Nervous system disorders
Irritability
|
0.00%
0/111 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/110 • Baseline to 30 Days After Last Dose of Study Drug
|
0.85%
1/118 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/228 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Nervous system disorders
Homocidal ideation
|
0.90%
1/111 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/110 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/118 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/228 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/111 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/110 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/118 • Baseline to 30 Days After Last Dose of Study Drug
|
0.44%
1/228 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
Other adverse events
| Measure |
80 mg LY2140023, BID
n=111 participants at risk
160 milligrams per day (mg/day) LY2140023: An 80-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization with the exception of the first 3 days of treatment, post-randomization, when a 40-mg LY2140023 tablet was administered orally, BID.
|
40 mg LY2140023, BID
n=110 participants at risk
80 mg/day LY2140023: A 40-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
10 mg LY2140023, BID
n=118 participants at risk
20 mg/day LY2140023: A 10-mg LY2140023 tablet, administered orally, BID for 6 weeks, post-randomization.
|
Placebo
n=228 participants at risk
Placebo tablets, identical to LY2140023, administered orally, BID for 6 weeks, post-randomization.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.8%
2/111 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
2.7%
3/110 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
2.5%
3/118 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
1.8%
4/228 • Number of events 4 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
2/111 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
2.7%
3/110 • Number of events 4 • Baseline to 30 Days After Last Dose of Study Drug
|
1.7%
2/118 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
0.88%
2/228 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Gastrointestinal disorders
Constipation
|
2.7%
3/111 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
7.3%
8/110 • Number of events 8 • Baseline to 30 Days After Last Dose of Study Drug
|
4.2%
5/118 • Number of events 5 • Baseline to 30 Days After Last Dose of Study Drug
|
3.9%
9/228 • Number of events 10 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Gastrointestinal disorders
Diarrhoea
|
0.90%
1/111 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
3.6%
4/110 • Number of events 4 • Baseline to 30 Days After Last Dose of Study Drug
|
4.2%
5/118 • Number of events 5 • Baseline to 30 Days After Last Dose of Study Drug
|
3.9%
9/228 • Number of events 10 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
4/111 • Number of events 4 • Baseline to 30 Days After Last Dose of Study Drug
|
2.7%
3/110 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
3.4%
4/118 • Number of events 4 • Baseline to 30 Days After Last Dose of Study Drug
|
2.6%
6/228 • Number of events 8 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Gastrointestinal disorders
Nausea
|
8.1%
9/111 • Number of events 9 • Baseline to 30 Days After Last Dose of Study Drug
|
10.9%
12/110 • Number of events 15 • Baseline to 30 Days After Last Dose of Study Drug
|
10.2%
12/118 • Number of events 12 • Baseline to 30 Days After Last Dose of Study Drug
|
4.4%
10/228 • Number of events 10 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Gastrointestinal disorders
Toothache
|
0.90%
1/111 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
1.8%
2/110 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
0.85%
1/118 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
2.2%
5/228 • Number of events 5 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
4/111 • Number of events 5 • Baseline to 30 Days After Last Dose of Study Drug
|
6.4%
7/110 • Number of events 8 • Baseline to 30 Days After Last Dose of Study Drug
|
5.1%
6/118 • Number of events 8 • Baseline to 30 Days After Last Dose of Study Drug
|
3.9%
9/228 • Number of events 11 • Baseline to 30 Days After Last Dose of Study Drug
|
|
General disorders
Irritability
|
0.00%
0/111 • Baseline to 30 Days After Last Dose of Study Drug
|
0.91%
1/110 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/118 • Baseline to 30 Days After Last Dose of Study Drug
|
2.6%
6/228 • Number of events 6 • Baseline to 30 Days After Last Dose of Study Drug
|
|
General disorders
Pain
|
2.7%
3/111 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
2.7%
3/110 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
1.7%
2/118 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
0.44%
1/228 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
2/111 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
2.7%
3/110 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
0.85%
1/118 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
1.8%
4/228 • Number of events 4 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/33 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/28 • Baseline to 30 Days After Last Dose of Study Drug
|
3.3%
1/30 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
1.5%
1/66 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Investigations
Blood creatine phosphokinase increased
|
4.5%
5/111 • Number of events 5 • Baseline to 30 Days After Last Dose of Study Drug
|
3.6%
4/110 • Number of events 4 • Baseline to 30 Days After Last Dose of Study Drug
|
4.2%
5/118 • Number of events 5 • Baseline to 30 Days After Last Dose of Study Drug
|
5.7%
13/228 • Number of events 13 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.90%
1/111 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
2.7%
3/110 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
0.85%
1/118 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
2.2%
5/228 • Number of events 6 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
2/111 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
1.8%
2/110 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
2.5%
3/118 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
0.88%
2/228 • Number of events 4 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
6/111 • Number of events 6 • Baseline to 30 Days After Last Dose of Study Drug
|
4.5%
5/110 • Number of events 6 • Baseline to 30 Days After Last Dose of Study Drug
|
0.85%
1/118 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
1.8%
4/228 • Number of events 4 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
2/111 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/110 • Baseline to 30 Days After Last Dose of Study Drug
|
4.2%
5/118 • Number of events 6 • Baseline to 30 Days After Last Dose of Study Drug
|
2.6%
6/228 • Number of events 6 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Nervous system disorders
Akathisia
|
0.00%
0/111 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/110 • Baseline to 30 Days After Last Dose of Study Drug
|
2.5%
3/118 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
2.2%
5/228 • Number of events 5 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Nervous system disorders
Dizziness
|
0.00%
0/111 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/110 • Baseline to 30 Days After Last Dose of Study Drug
|
2.5%
3/118 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
1.3%
3/228 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Nervous system disorders
Headache
|
14.4%
16/111 • Number of events 18 • Baseline to 30 Days After Last Dose of Study Drug
|
10.9%
12/110 • Number of events 13 • Baseline to 30 Days After Last Dose of Study Drug
|
9.3%
11/118 • Number of events 12 • Baseline to 30 Days After Last Dose of Study Drug
|
9.6%
22/228 • Number of events 23 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Nervous system disorders
Somnolence
|
0.90%
1/111 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
0.91%
1/110 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
3.4%
4/118 • Number of events 4 • Baseline to 30 Days After Last Dose of Study Drug
|
2.2%
5/228 • Number of events 5 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Nervous system disorders
Tremor
|
1.8%
2/111 • Number of events 11 • Baseline to 30 Days After Last Dose of Study Drug
|
1.8%
2/110 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
2.5%
3/118 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
2.2%
5/228 • Number of events 5 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Psychiatric disorders
Anxiety
|
2.7%
3/111 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
4.5%
5/110 • Number of events 5 • Baseline to 30 Days After Last Dose of Study Drug
|
2.5%
3/118 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
1.8%
4/228 • Number of events 4 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Psychiatric disorders
Insomnia
|
2.7%
3/111 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
3.6%
4/110 • Number of events 4 • Baseline to 30 Days After Last Dose of Study Drug
|
6.8%
8/118 • Number of events 9 • Baseline to 30 Days After Last Dose of Study Drug
|
3.1%
7/228 • Number of events 8 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Psychiatric disorders
Psychotic disorder
|
3.6%
4/111 • Number of events 4 • Baseline to 30 Days After Last Dose of Study Drug
|
2.7%
3/110 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
1.7%
2/118 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
1.3%
3/228 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Psychiatric disorders
Schizophrenia
|
1.8%
2/111 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
3.6%
4/110 • Number of events 4 • Baseline to 30 Days After Last Dose of Study Drug
|
1.7%
2/118 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
1.8%
4/228 • Number of events 4 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/33 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/28 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/30 • Baseline to 30 Days After Last Dose of Study Drug
|
3.0%
2/66 • Number of events 2 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/33 • Baseline to 30 Days After Last Dose of Study Drug
|
3.6%
1/28 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/30 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/66 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/33 • Baseline to 30 Days After Last Dose of Study Drug
|
3.6%
1/28 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/30 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/66 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/33 • Baseline to 30 Days After Last Dose of Study Drug
|
3.6%
1/28 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/30 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/66 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/111 • Baseline to 30 Days After Last Dose of Study Drug
|
4.5%
5/110 • Number of events 6 • Baseline to 30 Days After Last Dose of Study Drug
|
0.85%
1/118 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
1.3%
3/228 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
6/111 • Number of events 8 • Baseline to 30 Days After Last Dose of Study Drug
|
0.00%
0/110 • Baseline to 30 Days After Last Dose of Study Drug
|
0.85%
1/118 • Number of events 1 • Baseline to 30 Days After Last Dose of Study Drug
|
1.3%
3/228 • Number of events 3 • Baseline to 30 Days After Last Dose of Study Drug
|
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