Schizophrenia MedDRA version: 9.1 Level: LLT Classification code 10039626 Term: Schizophrenia
Conditions
Interventions
Trade Name: Risperidone
Product Name: Risperidone
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RISPERIDONE
CAS Number: 106266062
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
LWL University Hospital Bochum, Ruhr-University Bochum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients, 18 to 65 years of age - Diagnosis of schizophrenia according to DSM-IV - Female patients must test negative for pregnancy and must be using a medically accepted means of contraception - Patients in whom a minimum in-patient hospitalisation stay of at least 5 weeks is acceptable - Patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol - Patients must be able to understand the nature of the study and have given their own 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: - Patients in whom treatment with risperidone, rimonabant, or placebo is relatively or absolutely clinically contraindicated - Patients who have received an experimental drug or used an experimental medical device for any indication within 30 days prior to study onset - Female patients who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study - DSM-IV diagnosis of substance dependence - Patients at risk of suicide - Patients with acute, serious, or unstable medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of efficacy of rimonabant as adjunctive therapy to risperidone to improve cognition in schizophrenia;Secondary Objective: Evaluation of safety parameters of rimonabant adjunctively given to risperidone;Primary end point(s): - Reduction of Positive and Negative Syndrome Scale (PANSS)-Score - Improvement of neuropsychological and neurophysiological cognitive parameters | — |
Countries
Germany
Outcome results
None listed