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This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, fixed-dosed phase II clinical study to evaluate the efficacy and safety of LY03020 in chinese acutely psychotic adult subjects with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY03020 | Experimental | Subjects will take LY03020 from Day 1 to Day 48 |
|
| Placebo | Placebo Comparator | Subjects will take Placebo from Day 1 to Day 48 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY03020 | Drug | administered orally |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score | The total score is 30-210, higher score is indicative of greater symptomatology. | baseline to week 6 of maintenance treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in PANSS Positive subscale score | The PANSS Positive subscale score is 7-49, higher score is indicative of greater symptomatology. | baseline to week 6 of maintenance treatment |
| Change from Baseline in PANSS Negative subscale score |
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Inclusion Criteria:
Exclusion Criteria:
Within 1 week prior to randomization or within 5 half lives (whichever is longer), subject has been treated with short acting antipsychotic drugs or other psychoactive drugs (such as antidepressants, mood stabilizers, and antiepileptic drugs), except for anti-anxiety drugs or sedative hypnotic drugs that can be used according to the protocol; Within two treatment cycles prior to randomization, subject has used long-acting antipsychotic drugs; Within 4 weeks prior to randomization, subject has used monoamine oxidase inhibitors (MAOIs); Previously used sufficient amounts and periods of clozapine for the treatment of schizophrenia;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yufeng Wang | Contact | 18665029373 | wangyufeng@luye.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing AnDing Hospital Capital Medical University | Beijing | China |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Drug |
administered orally |
|
The PANSS Negative subscale score is 7-49, higher score is indicative of greater symptomatology. |
| baseline to week 6 of maintenance treatment |
| Change from Baseline in PANSS General Psychopathology subscale score | The PANSS General Psychopathology subscale score is 16-112, higher score is indicative of greater symptomatology. | baseline to week 6 of maintenance treatment |
| Change from Baseline in Clinical Global Impression-Severity (CGI-S) score | CGI-S is 0-7 with higher score is indicative of greater symptomatology | baseline to week 6 of maintenance treatment |
| The Incidence of Overall AEs | baseline to week 6 of maintenance treatment |