Schizophrenia MedDRA version: 9.1 Level: LLT Classification code 10039626 Term: Schizophrenia
Conditions
Interventions
Trade Name: Risperdal
Product Name: Risperidone
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RISPERIDONE
CAS Number: 106266062
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
LWL University Hospital Bochum, Ruhr-University Bochum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · male and female patients, 18 to 45 years of age · diagnosis of schizophrenia as defined in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.) · female patients must test negative for pregnancy and, if of childbearing potential, must be using a medically accepted means of contraception · patients in whom a minimum in-patient hospitalisation stay of at least 7 weeks (when enrolled in the study) is acceptable, in the clinical judgement of the investigator · 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, tetrabenazine, 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 Visit 1 · patients who have a history of inadequate response to an adequate treatment with risperidone, in the opinion of the investigator · patients who have received treatment with risperidone within 6 weeks prior to Visit 1 · patients who have a history of an inadequate response, in the opinion of the investigator, to 2 or more adequate antipsychotic medication trials of at least 8 weeks duration in the past 12 months prior to Visit 1 · patients who require concomitant treatment with any other medication with primary central nervous system activity, other than benzodiazepines and anticholinergics · patients who receive treatment with depot antipsychotic medication within 1 dosing interval, minimum of 4 weeks, prior to Visit 1 · patients who have received treatment with clozapine at doses greater than 200 mg daily within 12 months prior to Visit 1, or who have received any clozapine at all during the month before Visit 1 · patients at risk of suicide (e.g. history of any suicide attempts, any current suicidal intent including plan) · DSM-IV diagnosis of substance dependence (except nicotine and caffeine) · DSM-IV diagnosis of substance-induced psychosis within 7 days of Visit 1 · female patients who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study · aminotransferase levels > 2 times upper limit of normal (ULN) at Visit 1 · prolactin level > 200 ng/ml at Visit 1 · thyroid-stimulating hormone (TSH) > 10% above the ULN at Visit 1 · clinically significant ECG abnormalities at Visit 1 · patients with acute, serious, or unstable medical conditions · employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Evaluation of depressive symptoms, severity of disease, social functioning and compliance, as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS), the Clinical Global Impression-Severity (CGI-S), the Personal and Social Performance Scale (PSP), and the Drug Attitude Inventory 10 (DAI-10);Main Objective: Evaluation of efficacy of tetrabenazine as adjunctive therapy to risperidone to improve positive, negative and cognitive symptoms in first-episode schizophrenia, as assessed by the Positive and Negative Syndrome Scale (PANSS), the Wisconsin Card Sorting Test (WCST), the Continuous Performance Test (CPT), the Stroop Color Word Test (SCWT), the Hopkins Verbal Learning Test (HVLT), the Verbal Fluency Test (VFT), the Brief Assessment of Cognition in Schizophrenia (BACS), the auditory evoked mismatch negativity (MMN), the auditory evoked P300 potential, and the auditory evoked P50 potential;Primary end point(s): · changes in the Positive and Negative Syndrome Scale (PANSS) from baseline to endpoint (Day 42) and from baseline to interim weekly visits (Day 1 to 28) · improvement of neuropsychological and neurophysiological cognitive parameters | — |
Countries
Germany
Outcome results
None listed