Trial Outcomes & Findings for Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia (NCT NCT00615433)
NCT ID: NCT00615433
Last Updated: 2015-06-12
Results Overview
The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
478 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2015-06-12
Participant Flow
Participant milestones
| Measure |
40mg
Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
|
120mg
3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
|
15mg Olz
3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
|
Placebo
Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
120
|
119
|
123
|
116
|
|
Overall Study
COMPLETED
|
77
|
66
|
84
|
71
|
|
Overall Study
NOT COMPLETED
|
43
|
53
|
39
|
45
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia
Baseline characteristics by cohort
| Measure |
40mg
n=119 Participants
Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
|
120mg
n=118 Participants
3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
|
15mg Olz
n=122 Participants
3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
|
Placebo
n=116 Participants
Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
|
Total
n=475 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 11.0 • n=99 Participants
|
37.9 years
STANDARD_DEVIATION 11.2 • n=107 Participants
|
38.3 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
36.9 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
37.7 years
STANDARD_DEVIATION 10.9 • n=31 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
104 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
90 Participants
n=7 Participants
|
371 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=99 Participants
|
72 participants
n=107 Participants
|
74 participants
n=206 Participants
|
68 participants
n=7 Participants
|
284 participants
n=31 Participants
|
|
Region of Enrollment
Philippines
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
8 participants
n=206 Participants
|
5 participants
n=7 Participants
|
26 participants
n=31 Participants
|
|
Region of Enrollment
Lithuania
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
7 participants
n=206 Participants
|
8 participants
n=7 Participants
|
29 participants
n=31 Participants
|
|
Region of Enrollment
Colombia
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
12 participants
n=206 Participants
|
12 participants
n=7 Participants
|
48 participants
n=31 Participants
|
|
Region of Enrollment
India
|
23 participants
n=99 Participants
|
21 participants
n=107 Participants
|
21 participants
n=206 Participants
|
23 participants
n=7 Participants
|
88 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.
The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.
Outcome measures
| Measure |
40mg
n=118 Participants
Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
|
120mg
n=118 Participants
3 40 mg tablets taken orally once a day.
|
15mg Olz
n=121 Participants
3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
|
Placebo
n=114 Participants
Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
|
|---|---|---|---|---|
|
Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.
|
-25.7 Units on a scale
Interval -29.6 to -21.8
|
-23.6 Units on a scale
Interval -27.8 to -19.4
|
-28.7 Units on a scale
Interval -32.4 to -24.9
|
-16.0 Units on a scale
Interval -20.1 to -12.0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.
The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity.
Outcome measures
| Measure |
40mg
n=119 Participants
Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
|
120mg
n=118 Participants
3 40 mg tablets taken orally once a day.
|
15mg Olz
n=122 Participants
3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
|
Placebo
n=114 Participants
Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
|
|---|---|---|---|---|
|
CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.
|
-1.5 scale
Interval -1.7 to -1.3
|
-1.4 scale
Interval -1.6 to -1.2
|
-1.5 scale
Interval -1.7 to -1.4
|
-1.1 scale
Interval -1.3 to -0.9
|
Adverse Events
40mg
Serious events: 2 serious events
Other events: 90 other events
Deaths: 0 deaths
120mg
Serious events: 6 serious events
Other events: 96 other events
Deaths: 0 deaths
15mg Olz
Serious events: 5 serious events
Other events: 98 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
40mg
n=119 participants at risk
Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
|
120mg
n=118 participants at risk
3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
|
15mg Olz
n=122 participants at risk
3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
|
Placebo
n=116 participants at risk
Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
|
|---|---|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/119
|
0.00%
0/118
|
0.00%
0/122
|
0.86%
1/116
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/119
|
0.00%
0/118
|
0.00%
0/122
|
0.86%
1/116
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/119
|
0.00%
0/118
|
0.82%
1/122
|
0.00%
0/116
|
|
Gastrointestinal disorders
Heamatemesis
|
0.00%
0/119
|
0.00%
0/118
|
0.00%
0/122
|
0.86%
1/116
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/119
|
0.00%
0/118
|
0.82%
1/122
|
0.00%
0/116
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/119
|
0.00%
0/118
|
0.82%
1/122
|
0.00%
0/116
|
|
Psychiatric disorders
Agitation
|
0.84%
1/119
|
0.00%
0/118
|
0.00%
0/122
|
0.86%
1/116
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/119
|
0.00%
0/118
|
0.00%
0/122
|
0.86%
1/116
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/119
|
3.4%
4/118
|
0.82%
1/122
|
0.86%
1/116
|
|
Psychiatric disorders
Schizophrenia
|
0.84%
1/119
|
1.7%
2/118
|
0.82%
1/122
|
0.00%
0/116
|
|
Psychiatric disorders
Substance Abuse
|
0.84%
1/119
|
0.00%
0/118
|
0.00%
0/122
|
0.00%
0/116
|
|
Psychiatric disorders
Suicidal Ideation
|
0.84%
1/119
|
0.85%
1/118
|
0.82%
1/122
|
0.00%
0/116
|
Other adverse events
| Measure |
40mg
n=119 participants at risk
Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
|
120mg
n=118 participants at risk
3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
|
15mg Olz
n=122 participants at risk
3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
|
Placebo
n=116 participants at risk
Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.0%
6/119
|
7.6%
9/118
|
6.6%
8/122
|
5.2%
6/116
|
|
Gastrointestinal disorders
Dry Mouth
|
1.7%
2/119
|
2.5%
3/118
|
9.8%
12/122
|
0.86%
1/116
|
|
Gastrointestinal disorders
Dyspepsia
|
7.6%
9/119
|
7.6%
9/118
|
4.1%
5/122
|
6.0%
7/116
|
|
Gastrointestinal disorders
Nausea
|
10.9%
13/119
|
7.6%
9/118
|
4.9%
6/122
|
4.3%
5/116
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
1.7%
2/119
|
6.8%
8/118
|
0.82%
1/122
|
0.00%
0/116
|
|
Gastrointestinal disorders
Tootache
|
3.4%
4/119
|
2.5%
3/118
|
9.8%
12/122
|
5.2%
6/116
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
5/119
|
8.5%
10/118
|
1.6%
2/122
|
6.9%
8/116
|
|
Investigations
Weight Increased
|
1.7%
2/119
|
1.7%
2/118
|
20.5%
25/122
|
5.2%
6/116
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
5.0%
6/119
|
0.85%
1/118
|
1.6%
2/122
|
1.7%
2/116
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.84%
1/119
|
2.5%
3/118
|
5.7%
7/122
|
3.4%
4/116
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.0%
6/119
|
5.1%
6/118
|
5.7%
7/122
|
3.4%
4/116
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
2.5%
3/119
|
5.1%
6/118
|
2.5%
3/122
|
1.7%
2/116
|
|
Nervous system disorders
Akathisia
|
11.8%
14/119
|
22.9%
27/118
|
7.4%
9/122
|
0.86%
1/116
|
|
Nervous system disorders
Dizziness
|
4.2%
5/119
|
5.1%
6/118
|
2.5%
3/122
|
1.7%
2/116
|
|
Nervous system disorders
Dystonia
|
3.4%
4/119
|
7.6%
9/118
|
0.82%
1/122
|
0.86%
1/116
|
|
Nervous system disorders
Headache
|
21.8%
26/119
|
17.8%
21/118
|
13.9%
17/122
|
21.6%
25/116
|
|
Nervous system disorders
Parkinsonism
|
9.2%
11/119
|
11.0%
13/118
|
4.9%
6/122
|
1.7%
2/116
|
|
Nervous system disorders
Sedation
|
9.2%
11/119
|
13.6%
16/118
|
13.9%
17/122
|
3.4%
4/116
|
|
Nervous system disorders
Somnolence
|
9.2%
11/119
|
15.3%
18/118
|
9.0%
11/122
|
4.3%
5/116
|
|
Nervous system disorders
Tremor
|
1.7%
2/119
|
7.6%
9/118
|
5.7%
7/122
|
4.3%
5/116
|
|
Psychiatric disorders
Agitation
|
10.9%
13/119
|
5.9%
7/118
|
6.6%
8/122
|
5.2%
6/116
|
|
Psychiatric disorders
Anxiety
|
10.1%
12/119
|
10.2%
12/118
|
5.7%
7/122
|
6.9%
8/116
|
|
Psychiatric disorders
Insomnia
|
12.6%
15/119
|
11.9%
14/118
|
10.7%
13/122
|
11.2%
13/116
|
|
Psychiatric disorders
Psychotic Disorder
|
1.7%
2/119
|
0.00%
0/118
|
2.5%
3/122
|
6.0%
7/116
|
|
Psychiatric disorders
Restlessness
|
5.0%
6/119
|
3.4%
4/118
|
3.3%
4/122
|
2.6%
3/116
|
Additional Information
Josephine Cucchiaro, Executive Director
Sunovion Pharmacetuicals Inc.
Phone: 201-592-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee For multi-center studies, it is mandatory that the first publication is based on all data obtained from all analyses as stipulated in the protocol. Investigators participating in multicenter studies must agree not to present data gathered individually or by subgroup of centers before the full, initial publication, unless this has been agreed to by all other investigators and also by Sunovion.
- Publication restrictions are in place
Restriction type: OTHER