Schizophrenia
Conditions
Brief summary
To collect the safety and response of using Amisulpride in acute schizophrenic patients
Interventions
DRUGAmisulpride
Oral tablets
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient diagnosed as Diagnostic and Statistical Manual of Mental Disorder, 4th edition, as paranoid, disorganized or undifferentiated type of schizophrenia in acute episode
Exclusion criteria
* Patients previously treated with amisulpride * Patients have comorbidity which may interfere with the treatment or follow-up * Patients currently taking depot antipsychotics (at least 30 days washout period is needed) * Patients currently/ or recently (\< 3 months) withdrawn from drug or alcohol abuse * Pregnant or lactation The above information is not intended to contain all considerations relevant to a patient's potential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 |
|---|---|
| Adverse events | all across the study |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impressions | All accross the study |
| Patient compliance | all across the study |
| Percentage of patient completing treatment | all across the study |
| Changes in body weight | At baseline and day 84 |
Countries
Hong Kong
Outcome results
None listed