Status:
COMPLETED
Efficacy Study on Cognitive Functions in Schizophrenic Patients
Lead Sponsor:
Sanofi
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Primary objectives * To compare neurocognitive effects of amisulpride with those of risperidone in patients with chronic schizophrenia, as assessed by the general cognitive index, a measure of overal...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00761670
Start Date
September 1 2008
End Date
January 1 2010
Last Update
December 9 2010
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Budapest, Hungary