Schizophrenia
Conditions
Keywords
Blonanserin
Brief summary
A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone
Detailed description
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: * Blonanserin group: Blonanserin tablets+Risperidone mimetic tablets * Risperidone group: Risperidone tablets+Blonanserin mimetic tablets Objectives of Study : To evaluate the efficacy and safety of Blonanserin in treating schizophrenia
Interventions
DRUGBlonanserin
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.
DRUGRisperidone
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.
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 64 Years
Healthy volunteers
No
Inclusion criteria
* Subject met Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV-Text Revision(TR) criteria for a primary diagnosis of schizophrenia * Patients are 18≤age\<65 years of age on the day when informed consent is obtained. * Subject had a PANSS total score ≥70 and 120≥ at Screening * Subject had a score ≥4 on the PANSS at Screening and Baseline. * Subjects are willing and able to comply with study protocol including treatment in hospital. * Subjects or their legal guardians have signed the written informed consent form.
Exclusion criteria
* The subject was treatment with other Investigate product within 30 days. * Subject had a history of treatment with long-acting drug for anti schizophrenia within 56 days. * Subject had a history of treatment with clozapine within 28 days. * Subject With parkinson disease,etc
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8 | From baseline to the end of study、week 8(day 56)or before other antipsychotic taken. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in PANSS Subscale Score at the End of Treatment | week 8 | Mean Change in PANSS subscale score at the end of treatment at 8 weeks the frame of 8 weeks is from baseline |
| Mean Change in PANSS 5-factor Model | Week 8 | Mean change in PANSS 5-factor model from baseline at Week 8 |
| Mean Change in PANSS Symptom Scores | Week 8 | Mean change in PANSS symptom scores from baseline at Week 8 |
| Mean Change in PANSS Symptom Scores From Baseline at Each Visit | Each Visit | Mean change in PANSS symptom scores from baseline at each Visit from baseline at week 8 |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blonanserin Participants received 8-24mg tablet orally twice daily for 8 weeks | 128 |
| Risperidone Participants received 2-6mg tablet orally twice daily for 8 weeks | 133 |
| Total | 261 |
Baseline characteristics
| Characteristic | Blonanserin | Risperidone | 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 | 128 Participants | 133 Participants | 261 Participants |
| Sex: Female, Male Female | 70 Participants | 58 Participants | 128 Participants |
| Sex: Female, Male Male | 58 Participants | 75 Participants | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 126 / 130 | 122 / 134 |
| serious Total, serious adverse events | 1 / 130 | 3 / 134 |
Outcome results
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)
Time frame: From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blonanserin | Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8 | PPS analysis: At the end of treatment | -33.71 score on a scale | Standard Error 17.02 |
| Blonanserin | Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8 | ITT analysis: At the end of treatment | -30.59 score on a scale | Standard Error 18.53 |
| Risperidone | Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8 | ITT analysis: At the end of treatment | -33.56 score on a scale | Standard Error 16.89 |
| Risperidone | Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8 | PPS analysis: At the end of treatment | -36.31 score on a scale | Standard Error 14.09 |
Comparison: ANCOVA was employed to compare the changes of PANSS scores at week 8 relative to the baseline in these 2 groups. Least Squares Means 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).p-value: <0.0595% CI: [-0.36, 7.75]ANCOVA
Comparison: 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).p-value: <0.0595% CI: [-0.76, 6.65]ANCOVA
Secondary
Mean Change in PANSS 5-factor Model
Mean change in PANSS 5-factor model from baseline at Week 8
Time frame: Week 8
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
Time frame: week 8
Secondary
Mean Change in PANSS Symptom Scores
Mean change in PANSS symptom scores from baseline at Week 8
Time frame: Week 8
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
Time frame: Each Visit