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A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone
A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone
Trial drugs:
Objectives of Study :
To evaluate the efficacy and safety of Blonanserin in treating schizophrenia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blonanserin | Experimental | Antipsychotics |
|
| Risperidone | Active Comparator | Antipsychotics |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blonanserin | Drug | Blonanserin tablets: 8 - 24mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8 | Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 8 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.Change=(Week 8 Score - Baseline score) | From baseline to the end of study、week 8(day 56)or before other antipsychotic taken. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in PANSS Subscale Score at the End of Treatment | Mean Change in PANSS subscale score at the end of treatment at 8 weeks the frame of 8 weeks is from baseline | week 8 |
| Mean Change in PANSS 5-factor Model |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niufan Gu, MD | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anding Hospital | Beijing | Beijing Municipality | 100088 | China | ||
| Beijing Huilongguan Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Blonanserin | Blonanserin: Dosage Form: Tablet Dosage and Usage: 8~24mg/d ,b.i.d |
| FG001 | Risperidone | Risperidone: Dosage Form: Tablet Dosage and Usage: 2~6mg/d ,b.i.d |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Risperidone | Drug | Risperidone tablets: 2 - 6mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days. |
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Mean change in PANSS 5-factor model from baseline at Week 8
| Week 8 |
| Mean Change in PANSS Symptom Scores | Mean change in PANSS symptom scores from baseline at Week 8 | Week 8 |
| Mean Change in PANSS Symptom Scores From Baseline at Each Visit | Mean change in PANSS symptom scores from baseline at each Visit from baseline at week 8 | Each Visit |
| Beijing |
| Beijing Municipality |
| 100096 |
| China |
| Peking University Sixth Hospital | Beijing | Beijing Municipality | 100191 | China |
| Guangzhou Brain Hospital | Guangzhou | Guangdong | 510170 | China |
| Hebei Province Mental Health Center | Baoding | Hebei | 071000 | China |
| The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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267 subjects in participant flow, 3 subjects randomized and not treated, 2 subjects does not have baseline PANSS scale, 1 subject take Blonanserin, which IWRS's indicate he should take Risperidone and no PANSS scale collectted after first dose. Those 6 subjects excluded from Baseline Population. The Baseline population have 261 subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Blonanserin | Participants received 8-24mg tablet orally twice daily for 8 weeks |
| BG001 | Risperidone | Participants received 2-6mg tablet orally twice daily for 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8 | Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 8 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.Change=(Week 8 Score - Baseline score) | 267 subjects in participant flow, 3 subjects randomized and not treated, 2 subjects does not have baseline PANSS scale, 1 subject take Blonanserin, which randomized to Risperidone group and no PANSS scale collected after first dose. Those 6 subjects excluded from Baseline Population. The Baseline population have 261 subjects. | Posted | Mean | Standard Error | score on a scale | From baseline to the end of study、week 8(day 56)or before other antipsychotic taken. |
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| Secondary | Mean Change in PANSS Subscale Score at the End of Treatment | Mean Change in PANSS subscale score at the end of treatment at 8 weeks the frame of 8 weeks is from baseline | Not Posted | week 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in PANSS 5-factor Model | Mean change in PANSS 5-factor model from baseline at Week 8 | Not Posted | Week 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in PANSS Symptom Scores | Mean change in PANSS symptom scores from baseline at Week 8 | Not Posted | Week 8 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in PANSS Symptom Scores From Baseline at Each Visit | Mean change in PANSS symptom scores from baseline at each Visit from baseline at week 8 | Not Posted | Each Visit | Participants |
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Safety analysis set (SS, the primary analysis set for safety evaluation) SS of this study included all randomized subjects who have received at least 1 dose of the trial drug.
The SS population have 130 subjects in Blonanserin group, 134 subjects in Risperidone group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blonanserin | Participants received 8-24mg tablet orally twice daily for 8 weeks | 1 | 130 | 126 | 130 | ||
| EG001 | Risperidone | Participants received 2-6mg tablet orally twice daily for 8 weeks | 3 | 134 | 122 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| chicken pox | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment | One subject (random number 234) in blonanserin group developed "chicken pox" and recovered after quarantine, symptomatic and supportive treatment; in the investigator's opinions, this case was unrelated to the study drug. |
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| Urinary retention | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
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| Gastrointestinal foreign matter | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| fever of unknown origin | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
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| Sinus arrhythmia | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
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| Galactorrhea | Endocrine disorders | MedDRA (15.1) | Systematic Assessment |
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| Blurred vision | Eye disorders | MedDRA (15.1) | Systematic Assessment |
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| constipation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Oropharyngeal pain | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Vomit | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Fatigue | Immune system disorders | MedDRA (15.1) | Systematic Assessment |
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| sleepiness | Immune system disorders | MedDRA (15.1) | Systematic Assessment |
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| Fever | Immune system disorders | MedDRA (15.1) | Systematic Assessment |
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| Abnormal liver function | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
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| Upperrespiratory tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
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| Tinea pedis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
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| Serum prolactin increase | Investigations | MedDRA (15.1) | Systematic Assessment |
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| Alanine aminotransferase increase | Investigations | MedDRA (15.1) | Systematic Assessment |
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| Aspartate aminotransferase increase | Investigations | MedDRA (15.1) | Systematic Assessment |
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| Blood triglycerides increase | Investigations | MedDRA (15.1) | Systematic Assessment |
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| Lipid increase | Investigations | MedDRA (15.1) | Systematic Assessment |
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| Body weight increase | Investigations | MedDRA (15.1) | Systematic Assessment |
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| Blood cholesterol increase | Investigations | MedDRA (15.1) | Systematic Assessment |
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| Transaminase increase | Investigations | MedDRA (15.1) | Systematic Assessment |
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| Blood potassium decrease | Investigations | MedDRA (15.1) | Systematic Assessment |
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| Poor appetite | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
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| Hyperlipidemina | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
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| Extrapyramidal disorders | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
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| Excitement | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
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| Poor sleep quality | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
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| Dysphoria | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
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| Somnipathy | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
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| Akathisia | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
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| Diffculty falling asleep | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Stuffy nose | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Expectoration | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.HuafangLi | Shang Hai Mental health center | 13641625395 | lhlh_5@163.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C079310 | blonanserin |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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| Male |
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| PPS analysis: At the end of treatment |
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This is ITT analysis data. |
| Non-Inferiority or Equivalence |
The power is 80%, non-inferiority margin is 7.0. |
| ANCOVA was employed to compare the changes of PANSS total scores at end of treatment relative to the baseline in these 2 groups. LSMeans for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model. H0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone> 7.0). | ANCOVA | Study center and grouping as fixed effects. | <0.05 | Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded. | Mean Difference (Final Values) | 2.94 | 2-Sided | 95 | -0.76 | 6.65 | This is PPS analysis data. | Non-Inferiority or Equivalence | The power is 80%, non-inferiority margin is 7.0. |