Trial Outcomes & Findings for Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia (NCT NCT02717195)
NCT ID: NCT02717195
Last Updated: 2019-11-25
Results Overview
PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia.
COMPLETED
PHASE3
1098 participants
From Randomization to Week 10
2019-11-25
Participant Flow
Patients who did not fulfil the randomization criteria for the DBT Period, were withdrawn from the study after the PC period. Patients who fulfilled the randomization criteria for the DBT Period, continued into the DBT Period. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment.
Participant milestones
| Measure |
Prospective Confirmation (PC) Period, Risperidone
Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks
Risperidone: 4-6 mg/day, encapsulated tablets, orally
|
PC Period, Olanzapine
Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks
Olanzapine: 15-20 mg/day, encapsulated tablets, orally
|
Double-blind Treatment (DBT) Period, Lu AF35700 10 mg
Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Lu AF35700 20 mg
Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Continued Treatment From PC Period
Patients in this arm will continue the treatment allocated in the PC Period at the dose set at last visit of the PC Period. The analysis is made independent on which treatment the patient was on (risperidone or olanzapine)
|
|---|---|---|---|---|---|
|
Prospective Confirmation (PC) Period
STARTED
|
711
|
387
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
COMPLETED
|
421
|
276
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
NOT COMPLETED
|
290
|
111
|
0
|
0
|
0
|
|
Double-blind Treatment (DBT) Period
STARTED
|
0
|
0
|
235
|
232
|
230
|
|
Double-blind Treatment (DBT) Period
COMPLETED
|
0
|
0
|
198
|
188
|
200
|
|
Double-blind Treatment (DBT) Period
NOT COMPLETED
|
0
|
0
|
37
|
44
|
30
|
Reasons for withdrawal
| Measure |
Prospective Confirmation (PC) Period, Risperidone
Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks
Risperidone: 4-6 mg/day, encapsulated tablets, orally
|
PC Period, Olanzapine
Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks
Olanzapine: 15-20 mg/day, encapsulated tablets, orally
|
Double-blind Treatment (DBT) Period, Lu AF35700 10 mg
Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Lu AF35700 20 mg
Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Continued Treatment From PC Period
Patients in this arm will continue the treatment allocated in the PC Period at the dose set at last visit of the PC Period. The analysis is made independent on which treatment the patient was on (risperidone or olanzapine)
|
|---|---|---|---|---|---|
|
Prospective Confirmation (PC) Period
Adverse Event
|
19
|
7
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Lack of Efficacy
|
2
|
1
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Non-compliance with IMP
|
7
|
1
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Protocol Violation
|
3
|
1
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Withdrawal by Subject
|
43
|
12
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Lost to Follow-up
|
9
|
4
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Did not fulfill rand criteria for DBT
|
189
|
75
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Enrolled but not treated
|
3
|
3
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Lack of results for blood levels
|
1
|
0
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Technical error
|
1
|
0
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Patient decision
|
5
|
2
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Low level of drug in the blood
|
1
|
0
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Change of place of residence
|
1
|
0
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Apato Abulcasis Syndrome
|
0
|
1
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Investigator decision
|
2
|
1
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Subject took exclusionary medication
|
0
|
1
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Sub therapeutic blood levels Olanzapine
|
1
|
0
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Positive Urine Drug Screen
|
0
|
1
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Duplicate subject
|
1
|
0
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Sponsor requested
|
0
|
1
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Patient fraud with payment
|
1
|
0
|
0
|
0
|
0
|
|
Prospective Confirmation (PC) Period
Noncompliance with protocol
|
1
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment (DBT) Period
Adverse Event
|
0
|
0
|
10
|
11
|
8
|
|
Double-blind Treatment (DBT) Period
Lack of Efficacy
|
0
|
0
|
6
|
9
|
2
|
|
Double-blind Treatment (DBT) Period
Non-compliance with IMP
|
0
|
0
|
4
|
3
|
2
|
|
Double-blind Treatment (DBT) Period
Protocol Violation
|
0
|
0
|
1
|
0
|
1
|
|
Double-blind Treatment (DBT) Period
Withdrawal by Subject
|
0
|
0
|
14
|
13
|
8
|
|
Double-blind Treatment (DBT) Period
Lost to Follow-up
|
0
|
0
|
0
|
3
|
2
|
|
Double-blind Treatment (DBT) Period
Enrolled but not treated
|
0
|
0
|
1
|
0
|
0
|
|
Double-blind Treatment (DBT) Period
Patient decision
|
0
|
0
|
0
|
2
|
2
|
|
Double-blind Treatment (DBT) Period
Investigator decision
|
0
|
0
|
0
|
1
|
1
|
|
Double-blind Treatment (DBT) Period
Family circumstances
|
0
|
0
|
0
|
0
|
1
|
|
Double-blind Treatment (DBT) Period
Change of residence
|
0
|
0
|
0
|
1
|
1
|
|
Double-blind Treatment (DBT) Period
Needed antidepressant medication
|
0
|
0
|
0
|
0
|
1
|
|
Double-blind Treatment (DBT) Period
Psychosocial issues
|
0
|
0
|
1
|
0
|
0
|
|
Double-blind Treatment (DBT) Period
Patient missed required visits
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia
Baseline characteristics by cohort
| Measure |
Non-randomized Patients
n=401 Participants
Patients not randomized into the double-blind treatment period, i.e. withdrawn from the study during or after the PC period, were analyzed as one arm independent of treatment.
|
Double-blind Treatment (DBT) Period, Lu AF35700 10 mg
n=235 Participants
Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Lu AF35700 20 mg
n=232 Participants
Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Continued Treatment From PC Period
n=230 Participants
Patients in this arm continued with the same treatment and dose as at the last visit of the PC Period. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment.
|
Total
n=1098 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 11.05 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 12.14 • n=7 Participants
|
42.3 years
STANDARD_DEVIATION 11.44 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 11.19 • n=4 Participants
|
43 years
STANDARD_DEVIATION 11.41 • n=21 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
421 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
254 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
677 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
224 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
357 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
142 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
177 Participants
n=4 Participants
|
682 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
172 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
275 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
186 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
178 Participants
n=4 Participants
|
719 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
36 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
|
PANSS total score
|
97.25 units on a scale
STANDARD_DEVIATION 11.21 • n=5 Participants
|
96.96 units on a scale
STANDARD_DEVIATION 9.17 • n=7 Participants
|
98.23 units on a scale
STANDARD_DEVIATION 9.29 • n=5 Participants
|
98.40 units on a scale
STANDARD_DEVIATION 9.84 • n=4 Participants
|
97.6 units on a scale
STANDARD_DEVIATION 10.12 • n=21 Participants
|
|
CGI-S score
|
4.82 units on a scale
STANDARD_DEVIATION 0.60 • n=5 Participants
|
4.88 units on a scale
STANDARD_DEVIATION 0.59 • n=7 Participants
|
5.00 units on a scale
STANDARD_DEVIATION 0.57 • n=5 Participants
|
4.90 units on a scale
STANDARD_DEVIATION 0.53 • n=4 Participants
|
4.89 units on a scale
STANDARD_DEVIATION 0.58 • n=21 Participants
|
PRIMARY outcome
Timeframe: From Randomization to Week 10Population: Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.
PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia.
Outcome measures
| Measure |
Double-blind Treatment (DBT) Period, Lu AF35700 10 mg
n=201 Participants
Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Lu AF35700 20 mg
n=189 Participants
Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Continued Treatment From PC Period
n=202 Participants
Patients in this arm will continue with the same treatment and dose as at the last visit of the PC Period (olanzapine or risperidone)
|
|---|---|---|---|
|
Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score
|
-10.01 units on a scale
Standard Error 0.96
|
-8.22 units on a scale
Standard Error 0.98
|
-9.90 units on a scale
Standard Error 0.97
|
SECONDARY outcome
Timeframe: From Randomization to Week 10Population: Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.
PSP is a clinician-rated scale designed and validated to measure a patient's current level of social functioning. It consists of 4 items: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviours. Each items were assessed on a 6-point scale, from 1 (absent) to 6 (very severe). PSP score was calculated as sum of all the items on the scale and ranged from 4 to 100. A higher score represents more severe functional impairment.
Outcome measures
| Measure |
Double-blind Treatment (DBT) Period, Lu AF35700 10 mg
n=204 Participants
Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Lu AF35700 20 mg
n=197 Participants
Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Continued Treatment From PC Period
n=203 Participants
Patients in this arm will continue with the same treatment and dose as at the last visit of the PC Period (olanzapine or risperidone)
|
|---|---|---|---|
|
Change From Randomization to Week 10 in PSP Total Personal and Social Performance (PSP) Total Score
|
4.90 units on a scale
Standard Error 0.96
|
3.23 units on a scale
Standard Error 0.98
|
3.94 units on a scale
Standard Error 0.98
|
SECONDARY outcome
Timeframe: From Randomization to Week 10Population: Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.
CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening.
Outcome measures
| Measure |
Double-blind Treatment (DBT) Period, Lu AF35700 10 mg
n=232 Participants
Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Lu AF35700 20 mg
n=231 Participants
Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Continued Treatment From PC Period
n=228 Participants
Patients in this arm will continue with the same treatment and dose as at the last visit of the PC Period (olanzapine or risperidone)
|
|---|---|---|---|
|
Change From Randomization to Week 10 in Global Clinical Impression - Severity of Illness (CGI-S) Score
|
-0.59 units on a scale
Standard Error 0.06
|
-0.54 units on a scale
Standard Error 0.06
|
-0.57 units on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: From Randomization to Week 10Population: Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.
PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. The Clinical Global Impression scale - severity of illness (CGI-S) is administered by the investigator. The patient is rated on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). A reduction in scale indicates improvement.
Outcome measures
| Measure |
Double-blind Treatment (DBT) Period, Lu AF35700 10 mg
n=201 Participants
Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Lu AF35700 20 mg
n=189 Participants
Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Continued Treatment From PC Period
n=202 Participants
Patients in this arm will continue with the same treatment and dose as at the last visit of the PC Period (olanzapine or risperidone)
|
|---|---|---|---|
|
Response at Week 10, Defined as ≥20% Reduction in PANSS Total Score, PANSS (Positive and Negative Syndrome Scale) Total Score ≤70, CGI-S (Clinical Global Impression Scale - Severity of Illness) Score <4
|
21 Participants
|
18 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From Randomization to Week 10Population: Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.
PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.
Outcome measures
| Measure |
Double-blind Treatment (DBT) Period, Lu AF35700 10 mg
n=201 Participants
Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Lu AF35700 20 mg
n=189 Participants
Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Continued Treatment From PC Period
n=202 Participants
Patients in this arm will continue with the same treatment and dose as at the last visit of the PC Period (olanzapine or risperidone)
|
|---|---|---|---|
|
Response at Week 10, Defined as ≥20% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization
|
82 Participants
|
59 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: From Randomization to Week 10Population: Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.
Positive and Negative Syndrome Scale (PANSS) total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.
Outcome measures
| Measure |
Double-blind Treatment (DBT) Period, Lu AF35700 10 mg
n=201 Participants
Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Lu AF35700 20 mg
n=189 Participants
Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Continued Treatment From PC Period
n=202 Participants
Patients in this arm will continue with the same treatment and dose as at the last visit of the PC Period (olanzapine or risperidone)
|
|---|---|---|---|
|
Response at Week 10, Defined as ≥30% Reduction in PANSS Total Score From Randomization
|
42 Participants
|
30 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: From Randomization to Week 10Population: Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.
PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.
Outcome measures
| Measure |
Double-blind Treatment (DBT) Period, Lu AF35700 10 mg
n=201 Participants
Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Lu AF35700 20 mg
n=189 Participants
Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Continued Treatment From PC Period
n=202 Participants
Patients in this arm will continue with the same treatment and dose as at the last visit of the PC Period (olanzapine or risperidone)
|
|---|---|---|---|
|
Response at Week 10, Defined as ≥40% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization
|
23 Participants
|
15 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: From Randomization to Week 10Population: Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.
PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.
Outcome measures
| Measure |
Double-blind Treatment (DBT) Period, Lu AF35700 10 mg
n=201 Participants
Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Lu AF35700 20 mg
n=189 Participants
Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Continued Treatment From PC Period
n=202 Participants
Patients in this arm will continue with the same treatment and dose as at the last visit of the PC Period (olanzapine or risperidone)
|
|---|---|---|---|
|
Response at Week 10, Defined as ≥50% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization
|
10 Participants
|
4 Participants
|
6 Participants
|
Adverse Events
Prospective Confirmation (PC) Period, Risperidone
PC Period, Olanzapine
Double Blind Treatment (DBT) Period, Lu AF35700 10 mg
DBT Period, Lu AF35700 20 mg
DBT Period, Continued Treatment From PC Period
Serious adverse events
| Measure |
Prospective Confirmation (PC) Period, Risperidone
n=708 participants at risk
Patients not randomized to double-blind treatment
|
PC Period, Olanzapine
n=384 participants at risk
Patients not randomized to double-blind treatment
|
Double Blind Treatment (DBT) Period, Lu AF35700 10 mg
n=235 participants at risk；n=234 participants at risk
Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Lu AF35700 20 mg
n=232 participants at risk
Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Continued Treatment From PC Period
n=230 participants at risk
Patients in this arm continued with the same treatment and dose as at the last visit of the PC Period. This arm is analyzed as one single treatment arm independent on which treatment was administered (olanzapine or risperidone).
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/708 • 22 weeks
|
0.00%
0/384 • 22 weeks
|
0.00%
0/234 • 22 weeks
|
0.43%
1/232 • 22 weeks
|
0.00%
0/230 • 22 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.14%
1/708 • 22 weeks
|
0.00%
0/384 • 22 weeks
|
0.00%
0/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.00%
0/230 • 22 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/708 • 22 weeks
|
0.00%
0/384 • 22 weeks
|
0.00%
0/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.43%
1/230 • 22 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/708 • 22 weeks
|
0.00%
0/384 • 22 weeks
|
0.43%
1/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.00%
0/230 • 22 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/708 • 22 weeks
|
0.00%
0/384 • 22 weeks
|
0.43%
1/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.00%
0/230 • 22 weeks
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/708 • 22 weeks
|
0.00%
0/384 • 22 weeks
|
0.43%
1/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.00%
0/230 • 22 weeks
|
|
General disorders
Vascular stent thrombosis
|
0.00%
0/708 • 22 weeks
|
0.00%
0/384 • 22 weeks
|
0.43%
1/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.00%
0/230 • 22 weeks
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/708 • 22 weeks
|
0.00%
0/384 • 22 weeks
|
0.00%
0/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.43%
1/230 • 22 weeks
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/708 • 22 weeks
|
0.00%
0/384 • 22 weeks
|
0.00%
0/234 • 22 weeks
|
0.43%
1/232 • 22 weeks
|
0.00%
0/230 • 22 weeks
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/708 • 22 weeks
|
0.26%
1/384 • 22 weeks
|
0.00%
0/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.00%
0/230 • 22 weeks
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/708 • 22 weeks
|
0.00%
0/384 • 22 weeks
|
0.00%
0/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.43%
1/230 • 22 weeks
|
|
Nervous system disorders
Presyncope
|
0.00%
0/708 • 22 weeks
|
0.26%
1/384 • 22 weeks
|
0.00%
0/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.00%
0/230 • 22 weeks
|
|
Psychiatric disorders
Acute psychosis
|
0.14%
1/708 • 22 weeks
|
0.00%
0/384 • 22 weeks
|
0.00%
0/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.00%
0/230 • 22 weeks
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/708 • 22 weeks
|
0.00%
0/384 • 22 weeks
|
0.43%
1/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.00%
0/230 • 22 weeks
|
|
Psychiatric disorders
Paranoia
|
0.28%
2/708 • 22 weeks
|
0.26%
1/384 • 22 weeks
|
0.00%
0/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.00%
0/230 • 22 weeks
|
|
Psychiatric disorders
Psychotic disorder
|
0.14%
1/708 • 22 weeks
|
0.26%
1/384 • 22 weeks
|
0.00%
0/234 • 22 weeks
|
0.43%
1/232 • 22 weeks
|
0.00%
0/230 • 22 weeks
|
|
Psychiatric disorders
Schizophrenia
|
0.71%
5/708 • 22 weeks
|
0.26%
1/384 • 22 weeks
|
0.43%
1/234 • 22 weeks
|
0.86%
2/232 • 22 weeks
|
0.87%
2/230 • 22 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.28%
2/708 • 22 weeks
|
0.26%
1/384 • 22 weeks
|
0.85%
2/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.43%
1/230 • 22 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/708 • 22 weeks
|
0.00%
0/384 • 22 weeks
|
0.00%
0/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.43%
1/230 • 22 weeks
|
|
Social circumstances
Social stay hospitalisation
|
0.14%
1/708 • 22 weeks
|
0.26%
1/384 • 22 weeks
|
0.00%
0/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.00%
0/230 • 22 weeks
|
|
Surgical and medical procedures
Psychosocial support
|
0.14%
1/708 • 22 weeks
|
0.00%
0/384 • 22 weeks
|
0.00%
0/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.00%
0/230 • 22 weeks
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/708 • 22 weeks
|
0.00%
0/384 • 22 weeks
|
0.43%
1/234 • 22 weeks
|
0.00%
0/232 • 22 weeks
|
0.00%
0/230 • 22 weeks
|
Other adverse events
| Measure |
Prospective Confirmation (PC) Period, Risperidone
n=708 participants at risk
Patients not randomized to double-blind treatment
|
PC Period, Olanzapine
n=384 participants at risk
Patients not randomized to double-blind treatment
|
Double Blind Treatment (DBT) Period, Lu AF35700 10 mg
n=235 participants at risk；n=234 participants at risk
Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Lu AF35700 20 mg
n=232 participants at risk
Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks
|
DBT Period, Continued Treatment From PC Period
n=230 participants at risk
Patients in this arm continued with the same treatment and dose as at the last visit of the PC Period. This arm is analyzed as one single treatment arm independent on which treatment was administered (olanzapine or risperidone).
|
|---|---|---|---|---|---|
|
Investigations
Weight increased
|
0.71%
5/708 • 22 weeks
|
0.26%
1/384 • 22 weeks
|
3.4%
8/235 • 22 weeks
|
8.2%
19/232 • 22 weeks
|
4.8%
11/230 • 22 weeks
|
|
Nervous system disorders
Headache
|
3.4%
24/708 • 22 weeks
|
4.2%
16/384 • 22 weeks
|
4.7%
11/235 • 22 weeks
|
6.5%
15/232 • 22 weeks
|
4.3%
10/230 • 22 weeks
|
|
Nervous system disorders
Somnolence
|
4.8%
34/708 • 22 weeks
|
7.8%
30/384 • 22 weeks
|
1.3%
3/235 • 22 weeks
|
3.9%
9/232 • 22 weeks
|
1.7%
4/230 • 22 weeks
|
|
Nervous system disorders
Akathisia
|
5.1%
36/708 • 22 weeks
|
2.1%
8/384 • 22 weeks
|
1.3%
3/235 • 22 weeks
|
2.2%
5/232 • 22 weeks
|
1.7%
4/230 • 22 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place