Schizophrenia
Conditions
Brief summary
Primary Objective: To evaluate the effectiveness of amisulpride in Chinese patients with schizophrenia Secondary Objective: To evaluate the overall safety of amisulpride in Chinese patients with schizophrenia.
Detailed description
The study duration by subject will include a 8-week treatment period with 3 follow-up visits.
Interventions
DRUGAMISULPRIDE
Pharmaceutical form: tablet Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
: * Satisfying International Classification of Disease-10 (ICD) diagnostic criteria of schizophrenia; * Positive and Negative Syndrome Scale (PANSS) total score ≥ 60
Exclusion criteria
* Refractory schizophrenia or Patients treated with sufficient clozapine for a minimum period of 6-8 weeks without improvement; * Participation into another clinical trial within the last month; * Patients previously or currently treated with amisulpride; * Patients receiving clozapine within the past 1 month or treated with long-acting formulation of antipsychotic medication within the past 2 months; * Patients receiving electric convulsive therapy or physical therapy within the past 1 month; * Patients with coexisting severe systemic diseases; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective percentage (PANSS score reduced rate≥50%) | Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression Scale- Improvement (CGI-I) | Baseline, Week 8 |
| Early response rate (PANSS score reduced rate: at least 20%) | week 2 |
| Positive and Negative Syndrome Scale (PANSS)-total score improvement | Baseline, Week 8 |
Countries
China
Outcome results
None listed