Schizophrenia
Conditions
Keywords
schizophrenia, Lurasidone, LATUDA
Brief summary
This is a randomized, double-blind, double-dummy, parallel- controlled, adjustable dose, non-inferiority and multicentre study designed to evaluate the efficacy and safety of lurasidone on schizophrenia for 6 weeks treatment, and to compare with risperidone.
Interventions
DRUGLurasidone tablets
Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo)
Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)
Sponsors
Sumitomo Pharma (Suzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent and aged between 18 and 65 years of age. * Meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia, had a PANSS total score ≥ 70 and ≤ 120 at Screening and Baseline, and a score ≥ 4 on the CGI-S at Screening and Baseline. * Not pregnant, if of reproductive potential agrees to use adequate and reliable contraception for duration of study. * Able and agrees to remain off prior antipsychotic medication for the duration of study. * Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.
Exclusion criteria
* Considered by the investigator to be at imminent risk of suicide or injury to self, others or property. * Any chronic organic disease of the CNS(other than schizophrenia) * Subjects are participating or participated in other clinical studies including marketed drugs or medical devices within 30 days before signing the informed consent form. * Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores. | From baseline to Week 6(day 42). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6. | From baseline to Week 6(day 42). | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lurasidone Group Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day | 194 |
| Risperidone Group Risperidone 2-6mg taken orally once a day and Lurasidone placebo tablets taken orally once a day. | 190 |
| Total | 384 |
Baseline characteristics
| Characteristic | Risperidone Group | Lurasidone Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 190 Participants | 194 Participants | 384 Participants |
| Age, Continuous | 34.8 years STANDARD_DEVIATION 10.71 | 34.6 years STANDARD_DEVIATION 11.12 | 34.7 years STANDARD_DEVIATION 10.91 |
| Region of Enrollment China | 190 participants | 194 participants | 384 participants |
| Sex: Female, Male Female | 89 Participants | 96 Participants | 185 Participants |
| Sex: Female, Male Male | 101 Participants | 98 Participants | 199 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 194 | 0 / 191 |
| other Total, other adverse events | 134 / 194 | 160 / 191 |
| serious Total, serious adverse events | 1 / 194 | 0 / 191 |
Outcome results
Primary
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores.
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Lurasidone Group | Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores. | -31.2 units on a scale |
| Risperidone Group | Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores. | -34.9 units on a scale |
95% CI: [1, 6.3]Mixed Models Analysis
Secondary
Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6.
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Lurasidone Group | Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6. | 2.0 units on a scale |
| Risperidone Group | Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6. | 1.9 units on a scale |