Trial Outcomes & Findings for Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia. (NCT NCT00790192)
NCT ID: NCT00790192
Last Updated: 2016-03-17
Results Overview
The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
488 participants
Primary outcome timeframe
Week 6
Results posted on
2016-03-17
Participant Flow
Participant milestones
| Measure |
Lurasidone 80 mg
Lurasidone 80 mg tablets taken orally once a day
|
Lurasidone 160 mg
Lurasidone 160 mg (4 tablets) taken orally once a day
|
Quetiapine XR 600mg
Quetiapine XR 600 mg (4 tablets) orally taken once a day
|
Placebo
Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to \>= 5%.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
125
|
121
|
120
|
122
|
|
Overall Study
COMPLETED
|
89
|
93
|
97
|
74
|
|
Overall Study
NOT COMPLETED
|
36
|
28
|
23
|
48
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.
Baseline characteristics by cohort
| Measure |
Lurasidone 80 mg
n=125 Participants
Lurasidone 80 mg tablets taken orally once a day
|
Lurasidone 160 mg
n=121 Participants
Lurasidone 160 mg (4 tablets) taken orally once a day
|
Quetiapine XR 600mg
n=120 Participants
Quetiapine XR 600 mg (4 tablets) orally taken once a day
|
Placebo
n=122 Participants
Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to \>= 5%.
|
Total
n=488 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
37.9 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
37.4 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
37.4 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
37.2 years
STANDARD_DEVIATION 10.8 • n=21 Participants
|
|
Gender
Female
|
29 participants
n=5 Participants
|
39 participants
n=7 Participants
|
42 participants
n=5 Participants
|
44 participants
n=4 Participants
|
154 participants
n=21 Participants
|
|
Gender
Male
|
96 participants
n=5 Participants
|
82 participants
n=7 Participants
|
77 participants
n=5 Participants
|
77 participants
n=4 Participants
|
332 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
37 participants
n=7 Participants
|
35 participants
n=5 Participants
|
39 participants
n=4 Participants
|
151 participants
n=21 Participants
|
|
Region of Enrollment
Ukraine
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
19 participants
n=5 Participants
|
17 participants
n=4 Participants
|
75 participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
13 participants
n=5 Participants
|
12 participants
n=4 Participants
|
49 participants
n=21 Participants
|
|
Region of Enrollment
Russian Federation
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
21 participants
n=5 Participants
|
22 participants
n=4 Participants
|
87 participants
n=21 Participants
|
|
Region of Enrollment
India
|
24 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
24 participants
n=4 Participants
|
98 participants
n=21 Participants
|
|
Region of Enrollment
Colombia
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
7 participants
n=4 Participants
|
26 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: 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 (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Outcome measures
| Measure |
Lurasidone 80 mg
n=125 Participants
Lurasidone 80 mg tablets taken orally once a day
|
Lurasidone 160 mg
n=121 Participants
Lurasidone 160 mg (4 tablets) taken orally once a day
|
Quetiapine XR 600mg
n=116 Participants
Quetiapine XR 600 mg (4 tablets) orally taken once a day
|
Placebo
n=120 Participants
Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to \>= 5%.
|
|---|---|---|---|---|
|
Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
|
-22.2 scores on a scale
Interval -25.7 to -18.7
|
-26.5 scores on a scale
Interval -30.0 to -23.0
|
-27.8 scores on a scale
Interval -31.3 to -24.2
|
-10.3 scores on a scale
Interval -13.9 to -6.7
|
SECONDARY outcome
Timeframe: 6-WeeksClinical Global Impression of Severity 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. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).
Outcome measures
| Measure |
Lurasidone 80 mg
n=125 Participants
Lurasidone 80 mg tablets taken orally once a day
|
Lurasidone 160 mg
n=121 Participants
Lurasidone 160 mg (4 tablets) taken orally once a day
|
Quetiapine XR 600mg
n=116 Participants
Quetiapine XR 600 mg (4 tablets) orally taken once a day
|
Placebo
n=120 Participants
Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to \>= 5%.
|
|---|---|---|---|---|
|
Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment
|
-1.5 scores on a scale
Interval -1.7 to -1.3
|
-1.7 scores on a scale
Interval -1.9 to -1.5
|
-1.7 scores on a scale
Interval -1.9 to -1.5
|
-0.9 scores on a scale
Interval -1.1 to -0.7
|
Adverse Events
Lurasidone 80 mg
Serious events: 1 serious events
Other events: 71 other events
Deaths: 0 deaths
Lurasidone 160 mg
Serious events: 4 serious events
Other events: 76 other events
Deaths: 0 deaths
Quetiapine XR 600mg
Serious events: 1 serious events
Other events: 70 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lurasidone 80 mg
n=125 participants at risk
Lurasidone 80 mg tablets taken orally once a day
|
Lurasidone 160 mg
n=121 participants at risk
Lurasidone 160 mg (4 tablets) taken orally once a day
|
Quetiapine XR 600mg
n=119 participants at risk
Quetiapine XR 600 mg (4 tablets) orally taken once a day
|
Placebo
n=121 participants at risk
Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to \>= 5%.
|
|---|---|---|---|---|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.80%
1/125 • Number of events 1 • 14 days post study therapy
|
3.3%
4/121 • Number of events 4 • 14 days post study therapy
|
0.84%
1/119 • Number of events 1 • 14 days post study therapy
|
3.3%
4/121 • Number of events 4 • 14 days post study therapy
|
|
Gastrointestinal disorders
Abdominal Hernia Obstructive
|
0.00%
0/125 • 14 days post study therapy
|
0.83%
1/121 • Number of events 1 • 14 days post study therapy
|
0.00%
0/119 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
|
General disorders
Non-cardiac Chest Pain
|
0.00%
0/125 • 14 days post study therapy
|
0.83%
1/121 • Number of events 1 • 14 days post study therapy
|
0.00%
0/119 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
|
Infections and infestations
Hepatitis Viral
|
0.00%
0/125 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
0.84%
1/119 • Number of events 119 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/125 • 14 days post study therapy
|
0.83%
1/121 • Number of events 1 • 14 days post study therapy
|
0.00%
0/119 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
|
Psychiatric disorders
Agression
|
0.00%
0/125 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
0.00%
0/119 • 14 days post study therapy
|
0.83%
1/121 • Number of events 1 • 14 days post study therapy
|
|
Psychiatric disorders
Pyschotic Disorder
|
0.00%
0/125 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
0.84%
1/119 • Number of events 1 • 14 days post study therapy
|
1.7%
2/121 • Number of events 2 • 14 days post study therapy
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/125 • 14 days post study therapy
|
0.83%
1/121 • Number of events 1 • 14 days post study therapy
|
0.00%
0/119 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
|
Psychiatric disorders
Suicidal Behavior
|
0.00%
0/125 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
0.00%
0/119 • 14 days post study therapy
|
0.83%
1/121 • Number of events 1 • 14 days post study therapy
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/125 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
0.00%
0/119 • 14 days post study therapy
|
1.7%
2/121 • Number of events 2 • 14 days post study therapy
|
|
Social circumstances
Physical Assault
|
0.80%
1/125 • Number of events 1 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
0.00%
0/119 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
|
Vascular disorders
Labile Hypertension
|
0.00%
0/125 • 14 days post study therapy
|
0.83%
1/121 • Number of events 1 • 14 days post study therapy
|
0.00%
0/119 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
Other adverse events
| Measure |
Lurasidone 80 mg
n=125 participants at risk
Lurasidone 80 mg tablets taken orally once a day
|
Lurasidone 160 mg
n=121 participants at risk
Lurasidone 160 mg (4 tablets) taken orally once a day
|
Quetiapine XR 600mg
n=119 participants at risk
Quetiapine XR 600 mg (4 tablets) orally taken once a day
|
Placebo
n=121 participants at risk
Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to \>= 5%.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.4%
3/125 • Number of events 3 • 14 days post study therapy
|
0.83%
1/121 • Number of events 1 • 14 days post study therapy
|
6.7%
8/119 • Number of events 8 • 14 days post study therapy
|
2.5%
3/121 • Number of events 3 • 14 days post study therapy
|
|
Gastrointestinal disorders
Dry Mouth
|
1.6%
2/125 • Number of events 2 • 14 days post study therapy
|
1.7%
2/121 • Number of events 2 • 14 days post study therapy
|
7.6%
9/119 • Number of events 9 • 14 days post study therapy
|
0.83%
1/121 • Number of events 1 • 14 days post study therapy
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
3/125 • Number of events 3 • 14 days post study therapy
|
5.8%
7/121 • Number of events 7 • 14 days post study therapy
|
2.5%
3/119 • Number of events 3 • 14 days post study therapy
|
3.3%
4/121 • Number of events 4 • 14 days post study therapy
|
|
Gastrointestinal disorders
Nausea
|
8.0%
10/125 • Number of events 10 • 14 days post study therapy
|
6.6%
8/121 • Number of events 8 • 14 days post study therapy
|
3.4%
4/119 • Number of events 4 • 14 days post study therapy
|
3.3%
4/121 • Number of events 4 • 14 days post study therapy
|
|
Gastrointestinal disorders
Vomiting
|
6.4%
8/125 • Number of events 8 • 14 days post study therapy
|
7.4%
9/121 • Number of events 9 • 14 days post study therapy
|
5.0%
6/119 • Number of events 6 • 14 days post study therapy
|
5.0%
6/121 • Number of events 6 • 14 days post study therapy
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.6%
2/125 • Number of events 2 • 14 days post study therapy
|
0.83%
1/121 • Number of events 1 • 14 days post study therapy
|
5.0%
6/119 • Number of events 6 • 14 days post study therapy
|
0.83%
1/121 • Number of events 1 • 14 days post study therapy
|
|
Investigations
Weight Increase
|
0.80%
1/125 • Number of events 1 • 14 days post study therapy
|
1.7%
2/121 • Number of events 2 • 14 days post study therapy
|
6.7%
8/119 • Number of events 8 • 14 days post study therapy
|
0.83%
1/121 • Number of events 1 • 14 days post study therapy
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
2/125 • Number of events 2 • 14 days post study therapy
|
0.83%
1/121 • Number of events 1 • 14 days post study therapy
|
5.9%
7/119 • Number of events 7 • 14 days post study therapy
|
0.83%
1/121 • Number of events 1 • 14 days post study therapy
|
|
Nervous system disorders
Akathisia
|
8.0%
10/125 • Number of events 10 • 14 days post study therapy
|
7.4%
9/121 • Number of events 9 • 14 days post study therapy
|
1.7%
2/119 • Number of events 2 • 14 days post study therapy
|
0.83%
1/121 • Number of events 1 • 14 days post study therapy
|
|
Nervous system disorders
Dizziness
|
4.8%
6/125 • Number of events 6 • 14 days post study therapy
|
5.8%
7/121 • Number of events 7 • 14 days post study therapy
|
13.4%
16/119 • Number of events 16 • 14 days post study therapy
|
1.7%
2/121 • Number of events 2 • 14 days post study therapy
|
|
Nervous system disorders
Headache
|
9.6%
12/125 • Number of events 12 • 14 days post study therapy
|
9.9%
12/121 • Number of events 12 • 14 days post study therapy
|
10.9%
13/119 • Number of events 13 • 14 days post study therapy
|
10.7%
13/121 • Number of events 13 • 14 days post study therapy
|
|
Nervous system disorders
Parkinsonism
|
5.6%
7/125 • Number of events 7 • 14 days post study therapy
|
6.6%
8/121 • Number of events 8 • 14 days post study therapy
|
3.4%
4/119 • Number of events 4 • 14 days post study therapy
|
0.00%
0/121 • 14 days post study therapy
|
|
Nervous system disorders
Somnolence
|
4.0%
5/125 • Number of events 5 • 14 days post study therapy
|
6.6%
8/121 • Number of events 8 • 14 days post study therapy
|
13.4%
16/119 • Number of events 16 • 14 days post study therapy
|
0.83%
1/121 • Number of events 1 • 14 days post study therapy
|
|
Psychiatric disorders
Agitation
|
3.2%
4/125 • Number of events 4 • 14 days post study therapy
|
5.0%
6/121 • Number of events 6 • 14 days post study therapy
|
2.5%
3/119 • Number of events 3 • 14 days post study therapy
|
8.3%
10/121 • Number of events 10 • 14 days post study therapy
|
|
Psychiatric disorders
Anxiety
|
7.2%
9/125 • Number of events 9 • 14 days post study therapy
|
3.3%
4/121 • Number of events 4 • 14 days post study therapy
|
0.84%
1/119 • Number of events 1 • 14 days post study therapy
|
8.3%
10/121 • Number of events 10 • 14 days post study therapy
|
|
Psychiatric disorders
Insomnia
|
11.2%
14/125 • Number of events 14 • 14 days post study therapy
|
6.6%
8/121 • Number of events 8 • 14 days post study therapy
|
4.2%
5/119 • Number of events 5 • 14 days post study therapy
|
9.1%
11/121 • Number of events 11 • 14 days post study therapy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place