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Keep this study
Lead
Sanofi
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis: DSM-IV schizophrenia (any subtype)
Duration of illness: ≥ 5 years
Concomitant standing or prn medications (except other antipsychotics and those contraindicated in the respective package inserts \[amisulpride or risperidone\]) are permitted during treatment phase, if they were present at a stable dose for at least 6 weeks prior to the start of initial treatment with study medication
Overall symptom severity: patients must evidence a total score of 60 or higher on the PANSS scale
Clinical Symptoms: A score of 4 (moderate) or greater on any of the 7 items of the PANSS Positive Symptom Subscale is present
Cognitive status (minimum performance level): subject must be able to validly complete the baseline MATRICS assessment
Clinical judgment by the investigator that treatments with amisulpride or risperidone are warranted due to suboptimal clinical outcome despite previous treatments
You may not be if
Past or current intolerance of amisulpride or risperidone side effects that are judged by the investigator to be unsafe, dose-limiting, or likely to result in study discontinuation.
Any contraindication for amisulpride or risperidone therapy as indicated in the drug description.
Presence of any unstable or untreated medical disorder.
Any history of seizures or seizure disorder other than febrile seizures of childhood;
History of positive hepatitis B surface antigen.
Any abnormal laboratory test that is judged to be clinically significant by the investigator.
A history of significant head injury/trauma, as defined by:
A. loss of consciousness (LOC) for more than 1 hour B. recurring seizures resulting from the head injury C. clear cognitive sequelae of the injury D. cognitive rehabilitation following the injury
Alcohol or substance dependence within the past 12 months or abuse within the past 3 months. Any subject with positive urine toxicology or alcohol use that is considered abnormal at baseline.
Clinically significant suicidal or homicidal behavior or attempts within past 6 months.
Pregnant or breast-feeding women
Absence of medically approved contraceptive methods for female of childbearing potential.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Clareo Health | Efficacy Study on Cognitive Functions in Schizophrenic Patients
