measure of overall cognitive functioning in chronic schizophrenia
Conditions
Interventions
Trade Name: AMITREX 100mg tablet and 200mg tablet
Product Name: amisulpride
Pharmaceutical Form: Tablet
Trade Name: RISPERDAL 1 mg film-coated tablet, 2mg film-coated tablet, 3 mg film-coated tablet
3mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
Sponsors
sanofi-aventis Zrt.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis: DSM-IV schizophrenia (any subtype) 2. Aged between 18 and 65 years 3. Sex: Male, or non pregnant female subjects 4. General Health: Satisfactory medical assessment with no clinically significant and relevant abnormalities 5. Duration of illness: = 5 years 6. 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 7. Overall symptom severity: patients must evidence a total score of 60 or higher on the PANSS scale 8. Clinical Symptoms: A score of 4 (moderate) or greater on any of the 7 items of the PANSS Positive Symptom Subscale (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility) is present 9. Cognitive status (minimum performance level): subject must be able to validly complete the baseline MATRICS assessment (validity of performance to be assessed by Chief Neuropsychologist or NP tester) 10. Clinical judgment by the investigator that treatments with amisulpride or risperidone are warranted due to suboptimal clinical outcome despite previous treatments 11. Patient is judged capable of understanding all relevant risks and potential benefits of the study and provides informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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. 2. Any contraindication for amisulpride or risperidone therapy as indicated in the drug description. (Contrainidications for amisulpride therapy: prolactine dependent tumours, phaeochromocytome, pregnant or breast feeding woman, creatinine-clearance<10 ml/min, combination with drugs are potential triggers for torsades de pointes and hypersensitivity / intolerance to the active substance or to any of the excipients. Contraindications for risperidone therapy: hypersensitivity / intolerance to the active substance or to any of the excipients.) 3. Presence of any unstable or untreated medical disorder. 4. Any history of seizures or seizure disorder other than febrile seizures of childhood; 5. History of positive hepatitis B surface antigen. 6. Any abnormal laboratory test that is judged to be clinically significant by the investigator. 7. 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 8. 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. 9. Clinically significant suicidal or homicidal behavior or attempts within past 6 months. 10. Any subject who is judged by the investigator to present a danger to self or others. 11. Any subject who is judged by the investigator to be unable or unlikely to comply with all study requirements, including adherence with prescribed medication regimen. 12. Pregnant or breast-feeding women (excluded by pregnancy test) 13. Absence of medically approved contraceptive methods for female of childbearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare neurocognitive effects of amisulpride with those of risperidone in patients with chronic schrizophrenia, as assessed by the general cognitive index, a measure of overall cognitive functioning in schrizophrenia ;Secondary Objective: Secondary analyses: how the two atypical agents’ neurocognitive effects compare with regard to their profile of therapeutic action; Investigate whether amisulpride elicits more improvement on negative symptoms compared to risperidone treatment, as measured by the total score on the SANS 8 and by the Negative Symptom Subscale of the PANSS; Assess whether amisulpride improves overall functioning and individual domains of psychotic symptoms compared to risperidone as measured by the Clinical Global Impression (CGI), and the total and positive and general psychopathology subscale scores of PANSS and by the individual domains of SANS, respectively; Evaluate the safety and tolerability of amisulpride and risperidone based on the study completion rates, and frequency of abnormal laboratory values, prolactin serum concentrations and on the Simpson Angus Scale for Extrapyramidal Symptoms (SAS) 10 and the Abnormal Involuntary Movement Scale (AIMS). ;Primary end point(s): Primary General cognitive index, as assessed by the overall average z-score based on the neurocognitive test (MATRICS) battery. Secondary Cognitive measures: Individual subscales scores in seven cognitive domains including speed of processing, attention/vigilance, working memory (verbal and nonverbal), verbal learning and memory, visual learning and memory, reasoning and problem solving and social cognition. Overall Clinical Effects: Clinical Global Impression (CGI). Clinical Symptoms/Ratings of psychopathology: The total and each of the subscale scores on the PANSS (positive and negative symptoms, general psychopathology), and the SANS (Attention; Affect; Alogia, asociality/Anhedonia; Avolition). Ratings of potential side effects: The total, subs | — |
Countries
Hungary
Outcome results
None listed