Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lurasidone group | Experimental |
| |
| Risperidone group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurasidone tablets | Drug | Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to Week 6(day 42). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhuoji CAI, MD | Capital Medical University Affiliated Beijing Anding Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University Affiliated Beijing Anding Hospital | Beijing | Beijing Municipality | 100088 | China | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lurasidone Group | Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day |
| FG001 | Risperidone Group | Risperidone 2-6mg tablets taken orally once a day and Lurasidone placebo tablets taken orally once a day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-treat population (ITT) : All randomized subjects who received at least one dose of study medication,were included in the Intent-to-treat population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lurasidone Group | Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day |
| BG001 | Risperidone Group | Risperidone 2-6mg taken orally once a day and Lurasidone placebo tablets taken orally once a day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From baseline to Week 6(day 42). |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lurasidone Group | Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA(16.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extrapyramidal disorder | Nervous system disorders | MedDRA(16.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Sumitomo Pharma (Suzhou) Co., Ltd. | +86-10-57322070 | luo@dsmpharm.com.cn |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Risperidone tablets | Drug | Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo) |
|
| From baseline to Week 6(day 42). |
| Beijing Huilongguan Hospital |
| Beijing |
| Beijing Municipality |
| 100096 |
| China |
| Peking University Sixth Hospital | Beijing | Beijing Municipality | 100191 | China |
| Guangzhou Brain Hospital | Guangzhou | Guangdong | 510370 | China |
| HeBei Mental Health Center | Baoding | Hebei | 071000 | China |
| Henan Provincial Mental Hospital | Xinxiang | Henan | 453002 | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410000 | China |
| Hunan Province Brain Hospital | Changsha | Hunan | 410007 | China |
| Nanjing Brain Hospital | Nanjing | Jiangsu | 210029 | China |
| Wuxi Mental Health Center | Wuxi | Jiangsu | 214000 | China |
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
| Xi'an Mental Health Center | Xi’an | Shanxi | 710061 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin Anding Hospital | Tianjin | Tianjin Municipality | 300222 | China |
| First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650032 | China |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Lurasidone Group |
Lurasidone 40 or 80 mg tablets taken orally once a day and Risperidone placebo tablets taken orally once a day. |
| OG001 | Risperidone Group | Risperidone 2-6mg tablets taken orally once a day and Lurasidone placebo tablets taken orally once a day. |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | From baseline to Week 6(day 42). |
|
|
|
| 0 |
| 194 |
| 1 |
| 194 |
| 134 |
| 194 |
| EG001 | Risperidone Group | Risperidone 2-6mg tablets taken orally once a day and Lurasidone placebo tablets taken orally once a day. | 0 | 191 | 0 | 191 | 160 | 191 |
| Akathisia | Nervous system disorders | MedDRA(16.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA(16.1) | Systematic Assessment |
|
| Poor quality sleep | Nervous system disorders | MedDRA(16.1) | Systematic Assessment |
|
| Hypertonia | Nervous system disorders | MedDRA(16.1) | Systematic Assessment |
|
| Consitpation | Gastrointestinal disorders | MedDRA(16.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA(16.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA(16.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA(16.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA(16.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA(16.1) | Systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | MedDRA(16.1) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA(16.1) | Systematic Assessment |
|
| Affect lability | Psychiatric disorders | MedDRA(16.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA(16.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA(16.1) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA(16.1) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA(16.1) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA(16.1) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA(16.1) | Systematic Assessment |
|
| Blood prolactin increased | Investigations | MedDRA(16.1) | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA(16.1) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA(16.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA(16.1) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA(16.1) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA(16.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA(16.1) | Systematic Assessment |
|
| Hyperprolactinaemia | Endocrine disorders | MedDRA(16.1) | Systematic Assessment |
|
Not provided
Not provided
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |