Trial Outcomes & Findings for Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia (NCT NCT00337662)
NCT ID: NCT00337662
Last Updated: 2010-02-17
Results Overview
Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - single-blind baseline (Week 0).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
628 participants
Primary outcome timeframe
Weeks 0, 3, 4, 6, 8, 12
Results posted on
2010-02-17
Participant Flow
Study Period I was the screening period prior to enrollment. Study Period II was a 2-week open-label lead-in period of risperidone 2-6mg/day, at which time determination of early onset status was determined. Study Period III was a 10-week, double-blind therapy period.
Participant milestones
| Measure |
NEO-OLZ
Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
|
NEO-RIS
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
Risperiodone Open-Label Lead-In
All patients completed a 2-week open-label risperidone lead-in period. This group contains all patients who started Study Period II.
Risperidone: 2-6 mg, oral, daily
|
|---|---|---|---|---|
|
Study Period II
STARTED
|
0
|
0
|
0
|
628
|
|
Study Period II
COMPLETED
|
0
|
0
|
0
|
522
|
|
Study Period II
NOT COMPLETED
|
0
|
0
|
0
|
106
|
|
Study Period III
STARTED
|
186
|
192
|
144
|
0
|
|
Study Period III
COMPLETED
|
126
|
134
|
100
|
0
|
|
Study Period III
NOT COMPLETED
|
60
|
58
|
44
|
0
|
Reasons for withdrawal
| Measure |
NEO-OLZ
Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
|
NEO-RIS
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
Risperiodone Open-Label Lead-In
All patients completed a 2-week open-label risperidone lead-in period. This group contains all patients who started Study Period II.
Risperidone: 2-6 mg, oral, daily
|
|---|---|---|---|---|
|
Study Period II
Lost to Follow-up
|
0
|
0
|
0
|
35
|
|
Study Period II
Withdrawal by Subject
|
0
|
0
|
0
|
20
|
|
Study Period II
Adverse Event
|
0
|
0
|
0
|
16
|
|
Study Period II
Physician Decision
|
0
|
0
|
0
|
13
|
|
Study Period II
Entry Criteria Not Met
|
0
|
0
|
0
|
6
|
|
Study Period II
Protocol Violation
|
0
|
0
|
0
|
6
|
|
Study Period II
Lack of Efficacy
|
0
|
0
|
0
|
7
|
|
Study Period II
Sponsor Decision
|
0
|
0
|
0
|
2
|
|
Study Period II
Parent/Caregiver Decision
|
0
|
0
|
0
|
1
|
|
Study Period III
Lost to Follow-up
|
14
|
16
|
14
|
0
|
|
Study Period III
Withdrawal by Subject
|
18
|
14
|
12
|
0
|
|
Study Period III
Adverse Event
|
9
|
10
|
8
|
0
|
|
Study Period III
Protocol Violation
|
3
|
8
|
2
|
0
|
|
Study Period III
Physician Decision
|
6
|
5
|
0
|
0
|
|
Study Period III
Entry Criteria Not Met
|
4
|
1
|
3
|
0
|
|
Study Period III
Lack of Efficacy
|
4
|
4
|
2
|
0
|
|
Study Period III
Parent/Caregiver Decision
|
0
|
0
|
2
|
0
|
|
Study Period III
Sponsor Decision
|
1
|
0
|
1
|
0
|
|
Study Period III
Clinical Relapse
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia
Baseline characteristics by cohort
| Measure |
NEO-OLZ
n=186 Participants
Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
|
NEO-RIS
n=192 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=144 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
Total
n=522 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
41.84 years
STANDARD_DEVIATION 10.92 • n=5 Participants
|
41.87 years
STANDARD_DEVIATION 11.34 • n=7 Participants
|
41.83 years
STANDARD_DEVIATION 10.88 • n=5 Participants
|
41.85 years
STANDARD_DEVIATION 11.04 • n=4 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
322 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
88 participants
n=5 Participants
|
92 participants
n=7 Participants
|
54 participants
n=5 Participants
|
234 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
80 participants
n=5 Participants
|
80 participants
n=7 Participants
|
74 participants
n=5 Participants
|
234 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
14 participants
n=5 Participants
|
18 participants
n=7 Participants
|
15 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
173 participants
n=5 Participants
|
176 participants
n=7 Participants
|
130 participants
n=5 Participants
|
479 participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
5 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Diagnosis
Schizophrenia/Schizophreniform Disorder
|
140 participants
n=5 Participants
|
144 participants
n=7 Participants
|
114 participants
n=5 Participants
|
398 participants
n=4 Participants
|
|
Diagnosis
Schizoaffective Bipolar Disorder
|
31 participants
n=5 Participants
|
25 participants
n=7 Participants
|
21 participants
n=5 Participants
|
77 participants
n=4 Participants
|
|
Diagnosis
Schizoaffective Depression
|
15 participants
n=5 Participants
|
23 participants
n=7 Participants
|
9 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Abnormal Involuntary Movement Scale - Non-Global Total Score
|
0.67 units on a scale
STANDARD_DEVIATION 1.82 • n=5 Participants
|
0.49 units on a scale
STANDARD_DEVIATION 1.48 • n=7 Participants
|
0.44 units on a scale
STANDARD_DEVIATION 1.38 • n=5 Participants
|
0.54 units on a scale
STANDARD_DEVIATION 1.58 • n=4 Participants
|
|
Barnes Akathisia Rating Scale Total Score
|
0.80 units on a scale
STANDARD_DEVIATION 1.81 • n=5 Participants
|
0.95 units on a scale
STANDARD_DEVIATION 1.97 • n=7 Participants
|
0.54 units on a scale
STANDARD_DEVIATION 1.64 • n=5 Participants
|
0.78 units on a scale
STANDARD_DEVIATION 1.83 • n=4 Participants
|
|
Modified Simpson-Angus Scale
|
0.12 units on a scale
STANDARD_DEVIATION 0.29 • n=5 Participants
|
0.14 units on a scale
STANDARD_DEVIATION 0.29 • n=7 Participants
|
0.13 units on a scale
STANDARD_DEVIATION 0.82 • n=5 Participants
|
0.13 units on a scale
STANDARD_DEVIATION 0.50 • n=4 Participants
|
|
Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score
|
13.52 units on a scale
STANDARD_DEVIATION 7.98 • n=5 Participants
|
12.49 units on a scale
STANDARD_DEVIATION 8.44 • n=7 Participants
|
7.29 units on a scale
STANDARD_DEVIATION 6.07 • n=5 Participants
|
11.42 units on a scale
STANDARD_DEVIATION 8.09 • n=4 Participants
|
|
Positive and Negative Syndrome Scale (PANSS) - Negative Subscale
|
21.18 units on a scale
STANDARD_DEVIATION 4.96 • n=5 Participants
|
20.94 units on a scale
STANDARD_DEVIATION 5.30 • n=7 Participants
|
15.83 units on a scale
STANDARD_DEVIATION 3.90 • n=5 Participants
|
19.62 units on a scale
STANDARD_DEVIATION 5.36 • n=4 Participants
|
|
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
|
21.50 units on a scale
STANDARD_DEVIATION 4.49 • n=5 Participants
|
20.95 units on a scale
STANDARD_DEVIATION 4.65 • n=7 Participants
|
15.37 units on a scale
STANDARD_DEVIATION 3.97 • n=5 Participants
|
19.61 units on a scale
STANDARD_DEVIATION 5.13 • n=4 Participants
|
|
Positive and Negative Syndrome Scale (PANSS) - Total Score
|
84.91 units on a scale
STANDARD_DEVIATION 13.81 • n=5 Participants
|
84.05 units on a scale
STANDARD_DEVIATION 14.81 • n=7 Participants
|
61.67 units on a scale
STANDARD_DEVIATION 12.85 • n=5 Participants
|
78.21 units on a scale
STANDARD_DEVIATION 17.24 • n=4 Participants
|
PRIMARY outcome
Timeframe: Weeks 0, 3, 4, 6, 8, 12Population: Intention to treat for patients with both baseline and any postbaseline assessment
Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - single-blind baseline (Week 0).
Outcome measures
| Measure |
NEO-RIS
n=189 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=138 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients
Change from Week 0 to Week 4
|
-14.81 units on a scale
Standard Error 1.16
|
-32.53 units on a scale
Standard Error 1.24
|
—
|
|
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients
Change from Week 0 to Week 6
|
-16.23 units on a scale
Standard Error 1.26
|
-32.90 units on a scale
Standard Error 1.36
|
—
|
|
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients
Change from Week 0 to Week 8
|
-18.10 units on a scale
Standard Error 1.31
|
-34.10 units on a scale
Standard Error 1.43
|
—
|
|
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients
Change from Week 0 to Week 12
|
-18.62 units on a scale
Standard Error 1.38
|
-35.09 units on a scale
Standard Error 1.50
|
—
|
|
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients
Change from Week 0 to Week 3
|
-11.90 units on a scale
Standard Error 1.15
|
-30.80 units on a scale
Standard Error 1.23
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 3, 4, 6, 8, 12Population: Intention to treat patients with both baseline and postbaseline assessment
Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - double-blind baseline (Week 2).
Outcome measures
| Measure |
NEO-RIS
n=189 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=179 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients
Change from Week 2 to Week 6
|
-11.25 units on a scale
Standard Error 0.98
|
-13.06 units on a scale
Standard Error 1.02
|
—
|
|
Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients
Change from Week 2 to Week 8
|
-13.13 units on a scale
Standard Error 1.00
|
-14.73 units on a scale
Standard Error 1.04
|
—
|
|
Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients
Change from Week 2 to Week 12
|
-13.53 units on a scale
Standard Error 1.13
|
-17.02 units on a scale
Standard Error 1.16
|
—
|
|
Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients
Change from Week 2 to Week 3
|
-6.94 units on a scale
Standard Error 0.82
|
-5.85 units on a scale
Standard Error 0.84
|
—
|
|
Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients
Change from Week 2 to Week 4
|
-9.82 units on a scale
Standard Error 0.86
|
-9.67 units on a scale
Standard Error 0.88
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 12Population: Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.
The number of participants who experienced a 20% or greater reduction in their PANSS Total score during the 12 weeks they were on risperidone.
Outcome measures
| Measure |
NEO-RIS
n=189 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=138 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score
>=20% Reduction - Yes
|
94 participants
|
119 participants
|
—
|
|
The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score
>=20% Reduction - No
|
95 participants
|
19 participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 12Population: Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.
The number of not early onset participants who experienced a 20% or greater reduction in PANSS Total Score at any time during the 12 weeks of combined Study Period II and Study Period III.
Outcome measures
| Measure |
NEO-RIS
n=189 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=179 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score
>=20% Reduction - Yes
|
94 participants
|
94 participants
|
—
|
|
The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score
>=20% Reduction - No
|
95 participants
|
85 participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 12Population: Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.
'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.
Outcome measures
| Measure |
NEO-RIS
n=189 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=138 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission
>=50% Reduction - Yes
|
67 participants
|
87 participants
|
—
|
|
Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission
>=50% Reduction - No
|
122 participants
|
51 participants
|
—
|
SECONDARY outcome
Timeframe: Week 2 to Week 12Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.
Outcome measures
| Measure |
NEO-RIS
n=189 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=179 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission
>=50% Reduction - Yes
|
67 participants
|
67 participants
|
—
|
|
Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission
>=50% Reduction - No
|
122 participants
|
112 participants
|
—
|
SECONDARY outcome
Timeframe: Week 2 to Week 12Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
Psychiatric Hospitalizations were measured by the Modified Schizophrenia Care and Assessment Program Health Questionnaire (SCAP-HQ) from which it could be determined the number of patients with a psychiatric episode that required an overnight stay in a hospital.
Outcome measures
| Measure |
NEO-RIS
n=184 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=137 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups
Required overnight stay in hospital: Yes
|
9 participants
|
10 participants
|
—
|
|
Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups
Required overnight stay in hospital: No
|
175 participants
|
127 participants
|
—
|
SECONDARY outcome
Timeframe: Week 2 to Week 12Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
Body mass index is an estimate of body fat based on body weight divided by height squared. Change = Endpoint minus baseline.
Outcome measures
| Measure |
NEO-RIS
n=179 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=188 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=139 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index
Baseline
|
29.97 kilogram per square meter
Standard Deviation 8.03
|
31.05 kilogram per square meter
Standard Deviation 8.04
|
31.13 kilogram per square meter
Standard Deviation 8.77
|
|
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index
Change from Baseline
|
0.63 kilogram per square meter
Standard Deviation 1.38
|
0.43 kilogram per square meter
Standard Deviation 1.45
|
0.10 kilogram per square meter
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Week 2 to Week 12Population: Total number of patients with the lab test at baseline and post-baseline.
Number of participants who experienced abnormal fasting laboratory values at any time during Study Period III. Laboratory reference ranges are dependent on the patient's gender, origin, and age.
Outcome measures
| Measure |
NEO-RIS
n=179 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=188 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=139 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants
Low total bilirubin
|
5 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants
High creatine phosphokinase
|
6 participants
|
1 participants
|
5 participants
|
|
Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants
High creatinine
|
2 participants
|
4 participants
|
3 participants
|
|
Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants
High hemoglobin A1c
|
6 participants
|
7 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants
Low sodium
|
4 participants
|
4 participants
|
4 participants
|
|
Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants
High prolactin
|
7 participants
|
8 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Week 2 to Week 12Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
Measures neuroleptic-induced parkinsonism. Total score consists of the sum of 10 items: 7 items (items 1, 3, 4, 7, 8, 9, 10) rated on a 4-point severity scale where 0=normal and 4=extreme, and 3 items (items 2, 5, 6) rated on a 2-point severity scale where 0=normal and 2=definitely abnormal/present. The total score ranges from 0 to 34.
Outcome measures
| Measure |
NEO-RIS
n=168 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=173 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=133 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale
|
-0.06 units on a scale
Standard Deviation 0.27
|
-0.03 units on a scale
Standard Deviation 0.26
|
-0.02 units on a scale
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Week 2 to Week 12Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
Evaluates akathisia associated with use of antipsychotic medications, includes objective and subjective component plus global impression rating for overall disorder. Components rated on scale of 0 to 3 for objective and subjective items and 0 to 5 for global clinical assessment, for total score of 0 (absence of akathisia) to 11 (severe akathisia).
Outcome measures
| Measure |
NEO-RIS
n=168 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=174 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=133 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score
|
-0.31 units on a scale
Standard Deviation 1.99
|
-0.13 units on a scale
Standard Deviation 2.04
|
-0.24 units on a scale
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: Week 2 to Week 12Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
A 12-item instrument assesses observed abnormal movements in different parts of body. Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42.
Outcome measures
| Measure |
NEO-RIS
n=168 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=173 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=132 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score
|
-0.38 units on a scale
Standard Deviation 1.73
|
0.11 units on a scale
Standard Deviation 2.07
|
-0.16 units on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: Week 2 and Week 12Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
Changes from Study Period III baseline to endpoint in sitting pulse rate. Change = Endpoint minus baseline.
Outcome measures
| Measure |
NEO-RIS
n=179 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=188 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=139 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate
Baseline
|
80.49 beats per minute
Standard Deviation 11.57
|
80.84 beats per minute
Standard Deviation 12.06
|
77.90 beats per minute
Standard Deviation 11.02
|
|
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate
Change from Baseline
|
-0.98 beats per minute
Standard Deviation 11.81
|
-2.52 beats per minute
Standard Deviation 11.50
|
-0.94 beats per minute
Standard Deviation 12.82
|
SECONDARY outcome
Timeframe: Week 2 and Week 12Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5- visit 9) visits.
Change from Study Period III baseline to endpoint in standing blood pressure. Change = Endpoint minus baseline.
Outcome measures
| Measure |
NEO-RIS
n=176 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=184 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=137 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure
Baseline
|
78.69 mm Hg
Standard Deviation 10.01
|
78.57 mm Hg
Standard Deviation 10.68
|
80.29 mm Hg
Standard Deviation 10.65
|
|
Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure
Change from Baseline
|
1.01 mm Hg
Standard Deviation 10.79
|
-0.20 mm Hg
Standard Deviation 9.96
|
-1.73 mm Hg
Standard Deviation 8.92
|
SECONDARY outcome
Timeframe: Week 2 and Week 12Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
Change from Study Period III baseline to endpoint in standing mean arterial pressure. Change = Endpoint minus baseline.
Outcome measures
| Measure |
NEO-RIS
n=176 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=184 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=137 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure
Baseline
|
93.53 mm Hg
Standard Deviation 10.24
|
93.81 mm Hg
Standard Deviation 11.42
|
94.60 mm Hg
Standard Deviation 10.67
|
|
Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure
Change from Baseline
|
0.68 mm Hg
Standard Deviation 9.58
|
-0.58 mm Hg
Standard Deviation 10.12
|
-1.94 mm Hg
Standard Deviation 8.13
|
SECONDARY outcome
Timeframe: Week 2 and Week 12Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
Change from Study Period III baseline to endpoint in standing pulse rate. Change = Endpoint minus baseline.
Outcome measures
| Measure |
NEO-RIS
n=175 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=180 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=137 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate
Change from Baseline
|
-1.13 beats per minute
Standard Deviation 14.20
|
-2.05 beats per minute
Standard Deviation 13.21
|
-0.56 beats per minute
Standard Deviation 12.40
|
|
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate
Baseline
|
85.57 beats per minute
Standard Deviation 12.83
|
85.32 beats per minute
Standard Deviation 13.54
|
82.39 beats per minute
Standard Deviation 11.46
|
SECONDARY outcome
Timeframe: Week 2 and Week 12Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
Change from Study Period III baseline to endpoint in standing systolic blood pressure. Change = Endpoint minus baseline.
Outcome measures
| Measure |
NEO-RIS
n=176 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=184 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=137 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure
Baseline
|
123.20 mm Hg
Standard Deviation 14.02
|
124.30 mm Hg
Standard Deviation 16.23
|
123.20 mm Hg
Standard Deviation 13.63
|
|
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure
Change from Baseline
|
0.01 mm Hg
Standard Deviation 12.90
|
-1.35 mm Hg
Standard Deviation 14.22
|
-2.36 mm Hg
Standard Deviation 10.78
|
SECONDARY outcome
Timeframe: Week 2 and Week 12Population: Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.
Change from Study Period III baseline to endpoint in body weight. Change = Endpoint minus baseline.
Outcome measures
| Measure |
NEO-RIS
n=179 Participants
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=188 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
EO-RIS
n=139 Participants
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
|
|---|---|---|---|
|
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight
Baseline
|
88.28 kilograms
Standard Deviation 23.52
|
90.25 kilograms
Standard Deviation 22.81
|
90.67 kilograms
Standard Deviation 25.39
|
|
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight
Change from Baseline
|
1.85 kilograms
Standard Deviation 3.97
|
1.29 kilograms
Standard Deviation 4.25
|
0.30 kilograms
Standard Deviation 3.26
|
Adverse Events
NEO-OLZ
Serious events: 19 serious events
Other events: 97 other events
Deaths: 0 deaths
NEO-RIS
Serious events: 12 serious events
Other events: 100 other events
Deaths: 0 deaths
EO-RIS
Serious events: 14 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NEO-OLZ
n=186 participants at risk
Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks.
|
NEO-RIS
n=192 participants at risk
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks.
|
EO-RIS
n=144 participants at risk
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.54%
1/186 • Number of events 1
|
0.00%
0/192
|
0.00%
0/144
|
|
General disorders
Chest pain
|
0.54%
1/186 • Number of events 1
|
0.00%
0/192
|
0.00%
0/144
|
|
General disorders
Pyrexia
|
0.54%
1/186 • Number of events 1
|
0.00%
0/192
|
0.00%
0/144
|
|
Infections and infestations
Gastrointestinal infection
|
0.54%
1/186 • Number of events 1
|
0.00%
0/192
|
0.00%
0/144
|
|
Infections and infestations
Pneumonia
|
0.00%
0/186
|
0.52%
1/192 • Number of events 1
|
0.69%
1/144 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/186
|
0.52%
1/192 • Number of events 1
|
0.00%
0/144
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/186
|
0.00%
0/192
|
0.69%
1/144 • Number of events 1
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/186
|
0.00%
0/192
|
0.69%
1/144 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/186
|
0.00%
0/192
|
0.69%
1/144 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/186
|
0.00%
0/192
|
0.69%
1/144 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/186
|
0.52%
1/192 • Number of events 1
|
0.00%
0/144
|
|
Psychiatric disorders
Depression
|
0.00%
0/186
|
0.52%
1/192 • Number of events 1
|
0.00%
0/144
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/186
|
0.52%
1/192 • Number of events 1
|
0.00%
0/144
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/186
|
0.52%
1/192 • Number of events 1
|
0.69%
1/144 • Number of events 1
|
|
Psychiatric disorders
Homicidal ideation
|
0.54%
1/186 • Number of events 1
|
0.00%
0/192
|
0.69%
1/144 • Number of events 1
|
|
Psychiatric disorders
Hostility
|
0.00%
0/186
|
0.52%
1/192 • Number of events 1
|
0.00%
0/144
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/186
|
0.00%
0/192
|
0.69%
1/144 • Number of events 1
|
|
Psychiatric disorders
Psychotic disorder
|
1.6%
3/186 • Number of events 3
|
1.0%
2/192 • Number of events 2
|
0.00%
0/144
|
|
Psychiatric disorders
Schizoaffective disorder
|
1.6%
3/186 • Number of events 4
|
0.52%
1/192 • Number of events 1
|
0.00%
0/144
|
|
Psychiatric disorders
Schizophrenia
|
2.2%
4/186 • Number of events 4
|
0.52%
1/192 • Number of events 1
|
3.5%
5/144 • Number of events 5
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.54%
1/186 • Number of events 1
|
0.00%
0/192
|
1.4%
2/144 • Number of events 2
|
|
Psychiatric disorders
Suicidal ideation
|
2.2%
4/186 • Number of events 4
|
1.0%
2/192 • Number of events 2
|
2.8%
4/144 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/186
|
0.52%
1/192 • Number of events 1
|
0.00%
0/144
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/186
|
0.52%
1/192 • Number of events 1
|
0.00%
0/144
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.54%
1/186 • Number of events 1
|
0.00%
0/192
|
0.00%
0/144
|
|
Vascular disorders
Hypertension
|
0.00%
0/186
|
0.00%
0/192
|
0.69%
1/144 • Number of events 1
|
Other adverse events
| Measure |
NEO-OLZ
n=186 participants at risk
Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks.
|
NEO-RIS
n=192 participants at risk
Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks.
|
EO-RIS
n=144 participants at risk
Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks.
|
|---|---|---|---|
|
Nervous system disorders
Tremor
|
1.6%
3/186 • Number of events 3
|
2.1%
4/192 • Number of events 5
|
1.4%
2/144 • Number of events 2
|
|
Psychiatric disorders
Agitation
|
1.6%
3/186 • Number of events 3
|
1.6%
3/192 • Number of events 3
|
2.1%
3/144 • Number of events 4
|
|
Psychiatric disorders
Anxiety
|
4.3%
8/186 • Number of events 8
|
4.2%
8/192 • Number of events 8
|
4.9%
7/144 • Number of events 7
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/186
|
0.52%
1/192 • Number of events 1
|
2.8%
4/144 • Number of events 4
|
|
Psychiatric disorders
Depression
|
0.54%
1/186 • Number of events 1
|
1.0%
2/192 • Number of events 2
|
2.1%
3/144 • Number of events 3
|
|
Eye disorders
Vision blurred
|
0.54%
1/186 • Number of events 1
|
1.0%
2/192 • Number of events 2
|
2.1%
3/144 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
1.6%
3/186 • Number of events 3
|
2.1%
4/192 • Number of events 5
|
1.4%
2/144 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
2/186 • Number of events 2
|
5.2%
10/192 • Number of events 11
|
2.8%
4/144 • Number of events 4
|
|
Gastrointestinal disorders
Dry mouth
|
2.2%
4/186 • Number of events 4
|
2.6%
5/192 • Number of events 6
|
3.5%
5/144 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
1.1%
2/186 • Number of events 2
|
1.6%
3/192 • Number of events 3
|
2.8%
4/144 • Number of events 4
|
|
Gastrointestinal disorders
Toothache
|
2.2%
4/186 • Number of events 4
|
0.52%
1/192 • Number of events 1
|
0.69%
1/144 • Number of events 1
|
|
General disorders
Fatigue
|
1.6%
3/186 • Number of events 3
|
2.1%
4/192 • Number of events 4
|
2.1%
3/144 • Number of events 3
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
4/186 • Number of events 4
|
1.0%
2/192 • Number of events 2
|
2.1%
3/144 • Number of events 3
|
|
Investigations
Weight increased
|
10.8%
20/186 • Number of events 20
|
5.2%
10/192 • Number of events 10
|
2.8%
4/144 • Number of events 4
|
|
Metabolism and nutrition disorders
Increased appetite
|
2.7%
5/186 • Number of events 5
|
4.7%
9/192 • Number of events 9
|
2.1%
3/144 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.54%
1/186 • Number of events 1
|
1.0%
2/192 • Number of events 2
|
2.1%
3/144 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.54%
1/186 • Number of events 1
|
1.0%
2/192 • Number of events 2
|
4.2%
6/144 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/186
|
0.00%
0/192
|
2.1%
3/144 • Number of events 3
|
|
Nervous system disorders
Akathisia
|
1.1%
2/186 • Number of events 2
|
2.6%
5/192 • Number of events 5
|
2.1%
3/144 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
1.6%
3/186 • Number of events 4
|
2.1%
4/192 • Number of events 4
|
0.69%
1/144 • Number of events 1
|
|
Nervous system disorders
Extrapyramidal disorder
|
1.6%
3/186 • Number of events 3
|
2.1%
4/192 • Number of events 4
|
3.5%
5/144 • Number of events 5
|
|
Nervous system disorders
Headache
|
4.8%
9/186 • Number of events 10
|
4.2%
8/192 • Number of events 10
|
4.9%
7/144 • Number of events 7
|
|
Nervous system disorders
Hypersomnia
|
0.54%
1/186 • Number of events 1
|
0.00%
0/192
|
2.1%
3/144 • Number of events 4
|
|
Nervous system disorders
Lethargy
|
1.1%
2/186 • Number of events 2
|
1.6%
3/192 • Number of events 3
|
8.3%
12/144 • Number of events 13
|
|
Nervous system disorders
Sedation
|
6.5%
12/186 • Number of events 13
|
5.7%
11/192 • Number of events 11
|
3.5%
5/144 • Number of events 5
|
|
Nervous system disorders
Somnolence
|
2.7%
5/186 • Number of events 5
|
5.7%
11/192 • Number of events 11
|
4.2%
6/144 • Number of events 6
|
|
Psychiatric disorders
Insomnia
|
3.8%
7/186 • Number of events 7
|
8.3%
16/192 • Number of events 16
|
2.8%
4/144 • Number of events 4
|
|
Psychiatric disorders
Restlessness
|
1.6%
3/186 • Number of events 3
|
2.6%
5/192 • Number of events 5
|
1.4%
2/144 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60