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This will be a multicenter, randomized, double-blind, placebo and active comparator parallel-controlled study designed to assess the safety and efficacy of VV119 (2.0 to 6.0 mg) for the treatment of adult participants diagnosed with DSM-5 schizophrenia who are in an acute exacerbation phase.
Aripiprazole (20 mg) is included as a positive control to confirm the assay sensitivity of the study. The primary objective of the study is to assess the efficacy of VV119 in adult inpatients with a Diagnostic and Statistical Manual-Fifth Edition (DSM-5) diagnosis of schizophrenia. The secondary objective of the study is to assess overall safety of VV119 in adult inpatients diagnosed with DSM-5 schizophrenia.The exploratory objective is to characterize the population PK and quantify PK/PD relationship of VV119 in schizophrenia patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VV119 capsules | Experimental | Capsule, 2 mg/4 mg /6 mg, administered orally once daily for 6 consecutive weeks |
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| Active Comparator | Active Comparator | Tablet, 20 mg , administered orally once daily for 6 consecutive weeks |
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| Placebo | Placebo Comparator | Capsule/Tablet, administered orally once daily for 6 consecutive weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VV119 2mg | Drug | VV119 capsules 1 capsule (2mg/capsule) + VV119 capsules placebo 2 capsules + aripiprazole tablet placebo 2 tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 | The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants were rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms. | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in PANSS Positive Score at Week 6 | The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. The positive symptoms in schizophrenia are the excess or distortion of normal functions such as hallucinations, delusions, grandiosity, and hostility. Participants were rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms. |
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Inclusion Criteria:
Male or female participants, 18-65 years,inclusive, at screening.
Body Mass Index of 18.5 to 35.0kg/m2 , and body weight no less than 50.0kg (males), body weight no less than 45.0kg (females).
Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI).
Participant is experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months before screening:a.Participans who have been recently hospitalized or who would benefit from hospitalization for an acute exacerbation or relapse of schizophrenia;b.If hospitalized at screening, the participant's current admission for acute exacerbation shall be ≤2 weeks.
Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening,Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items at screening:
Item 1 (P1; delusions) Item 2 (P2; conceptual disorganization) Item 3 (P3; hallucinatory behavior) Item 6 (P6; suspiciousness/persecution).
WOCBP and male participants and their partners shall use medically approved effective contraception throughout treatment and for 3 months after the final study drug dose, such as intrauterine devices, contraceptive pills, or condoms.
Participants who are able to understand and follow study plans and instructions; Participants who have voluntarily decided to participate in this study and signed the informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Duan Huaqing | Contact | +86-18061926005 | huaqing.duan@vigonvita.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wang Gang | Beijing Anding Hospital of Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anding Hospital of Capital Medical University | Beijing | Beijing Municipality | 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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| ID | Term |
|---|---|
| D044382 | Population Groups |
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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Parallel Assignment
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| VV119 4mg | Drug | VV119 capsules 2 capsules (2mg/capsule) + VV119 capsules placebo 1 capsules + aripiprazole tablet placebo 2 tablets |
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| VV119 6mg | Drug | VV119 capsule 3 capsules (2mg/capsule) + aripiprazole tablet placebo 2 tablets |
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| Aripiprazole tablet | Drug | VV119 capsule placebo 3 capsules (2mg/capsule) + aripiprazole tablet 2 tablets |
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| Placebo | Drug | VV119 capsule placebo 3 capsules (2mg/capsule) + aripiprazole tablet placebo 2 tablets |
|
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| Baseline and Week 6 |
| Change From Baseline in PANSS Negative Score at Week 6 | The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. The negative symptoms in schizophrenia are the diminution or loss of normal functions. Participants were rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms. | Baseline and Week 6 |
| Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 6 | The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices include the following: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. | Baseline and Week 6 |
| Clinical Global Impression - Improvement (CGI-I) Score at Week 6 | The rater or investigator rated the particpant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at baseline prior to the first dose of double-blind study medication. Response choices included the following: 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. | Week 6 |
| Response Rate at Week 6 | Response rate was defined as a reduction of ≥ 30% from baseline in PANSS Total Score | Week 6 |
| Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Score at Week 6 | CDSS is a clinician-administered scale measuring depressive symptom severity in schizophrenia patients. It includes 9 items scored 0-3 per item, total scores range from 0 to 27. Higher scores mean worse depressive symptoms. | Baseline and Week 6 |
| D006571 |
| Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |