Trial Outcomes & Findings for A Clinical Trial of Lurasidone in Treatment of Schizophrenia (NCT NCT02002832)
NCT ID: NCT02002832
Last Updated: 2019-11-15
Results Overview
Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 6 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores\<70 is the normal,but the scores\>120 is more serious.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
388 participants
Primary outcome timeframe
From baseline to Week 6(day 42).
Results posted on
2019-11-15
Participant Flow
Participant milestones
| Measure |
Lurasidone Group
Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day
|
Risperidone Group
Risperidone 2-6mg tablets taken orally once a day and Lurasidone placebo tablets taken orally once a day.
|
|---|---|---|
|
Overall Study
STARTED
|
194
|
194
|
|
Overall Study
COMPLETED
|
166
|
168
|
|
Overall Study
NOT COMPLETED
|
28
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial of Lurasidone in Treatment of Schizophrenia
Baseline characteristics by cohort
| Measure |
Lurasidone Group
n=194 Participants
Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day
|
Risperidone Group
n=190 Participants
Risperidone 2-6mg taken orally once a day and Lurasidone placebo tablets taken orally once a day.
|
Total
n=384 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
194 Participants
n=99 Participants
|
190 Participants
n=107 Participants
|
384 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
34.6 years
STANDARD_DEVIATION 11.12 • n=99 Participants
|
34.8 years
STANDARD_DEVIATION 10.71 • n=107 Participants
|
34.7 years
STANDARD_DEVIATION 10.91 • n=206 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
185 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
199 Participants
n=206 Participants
|
|
Region of Enrollment
China
|
194 participants
n=99 Participants
|
190 participants
n=107 Participants
|
384 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 6(day 42).Population: Intent-to-Treat 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.
Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 6 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores\<70 is the normal,but the scores\>120 is more serious.
Outcome measures
| Measure |
Lurasidone Group
n=194 Participants
Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day.
|
Risperidone Group
n=190 Participants
Risperidone 2-6mg tablets taken orally once a day and Lurasidone placebo tablets taken orally once a day.
|
|---|---|---|
|
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores.
|
-31.2 units on a scale
Interval -33.2 to -29.2
|
-34.9 units on a scale
Interval -36.8 to -32.9
|
SECONDARY outcome
Timeframe: From baseline to Week 6(day 42).Population: 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 Clinical Global Impression Scale-Improvement (CGI-I) Score is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to baseline state at the beginning of the intervention. Response is rated as one of the following, in which higher scores indicate less improvement or worsening: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse.
Outcome measures
| Measure |
Lurasidone Group
n=194 Participants
Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day.
|
Risperidone Group
n=190 Participants
Risperidone 2-6mg tablets taken orally once a day and Lurasidone placebo tablets taken orally once a day.
|
|---|---|---|
|
Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6.
|
2.0 units on a scale
Interval 1.9 to 2.1
|
1.9 units on a scale
Interval 1.8 to 2.0
|
Adverse Events
Lurasidone Group
Serious events: 1 serious events
Other events: 134 other events
Deaths: 0 deaths
Risperidone Group
Serious events: 0 serious events
Other events: 160 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lurasidone Group
n=194 participants at risk
Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day.
|
Risperidone Group
n=191 participants at risk
Risperidone 2-6mg tablets taken orally once a day and Lurasidone placebo tablets taken orally once a day.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.52%
1/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
0.00%
0/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
Other adverse events
| Measure |
Lurasidone Group
n=194 participants at risk
Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day.
|
Risperidone Group
n=191 participants at risk
Risperidone 2-6mg tablets taken orally once a day and Lurasidone placebo tablets taken orally once a day.
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.52%
1/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
2.6%
5/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Investigations
Blood prolactin increased
|
3.1%
6/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
14.1%
27/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Investigations
Transaminases increased
|
1.0%
2/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
3.1%
6/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Nervous system disorders
Extrapyramidal disorder
|
17.0%
33/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
38.2%
73/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Nervous system disorders
Akathisia
|
7.2%
14/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
13.6%
26/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Nervous system disorders
Dizziness
|
2.6%
5/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
4.2%
8/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Nervous system disorders
Poor quality sleep
|
1.5%
3/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
3.7%
7/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Nervous system disorders
Hypertonia
|
1.0%
2/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
3.1%
6/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Gastrointestinal disorders
Consitpation
|
12.9%
25/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
14.7%
28/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Gastrointestinal disorders
Nausea
|
3.6%
7/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
2.1%
4/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
6/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
1.6%
3/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
5/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
2.6%
5/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Psychiatric disorders
Insomnia
|
9.8%
19/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
9.9%
19/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Psychiatric disorders
Anxiety
|
6.2%
12/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
6.3%
12/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Psychiatric disorders
Initial insomnia
|
3.6%
7/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
3.1%
6/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Psychiatric disorders
Agitation
|
2.6%
5/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
1.6%
3/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Psychiatric disorders
Affect lability
|
2.1%
4/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
0.52%
1/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
19/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
14.7%
28/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
10/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
8.4%
16/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
4.1%
8/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
3.1%
6/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Cardiac disorders
Sinus bradycardia
|
3.6%
7/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
2.1%
4/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Cardiac disorders
Sinus tachycardia
|
1.0%
2/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
3.7%
7/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Investigations
Weight increased
|
0.52%
1/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
5.2%
10/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
General disorders
Asthenia
|
1.5%
3/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
2.6%
5/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
2/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
2.1%
4/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Eye disorders
Vision blurred
|
0.52%
1/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
2.1%
4/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.52%
1/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
2.1%
4/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.52%
1/194 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
3.1%
6/191 • Date of first dose of study medication and up to 7 days after date of last dose of treatment in double-blind phase, an average of 7 weeks.
Of the 388 randomized subjects, 385 subjects received at least 1 dose of study medication and were therefore included in the Safety population: 194 (100%) in the lurasidone group and 191 (98.5%) in the risperidone group.
|
Additional Information
Chief Medical Officer
Sumitomo Pharma (Suzhou) Co., Ltd.
Phone: +86-10-57322070
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place