Comparative efficacy of amisulpride vs. risperidone on cognitive functions in patients with chronic schizophrenia.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 102

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

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.