A randomized controlled trial comparing the effect of clozapine and risperidone on cannabis craving in cannabis abusing or dependent patients with schizophrenia. Specific cognitive tasks will be used to test craving pathways and associated brain activities are assessed with functional MRI.
Conditions
Interventions
Product Name: Clozapine
Pharmaceutical Form: Tablet
INN or Proposed INN: CLOZAPINE
CAS Number: 5786210
Product Name: Risperidone
Pharmaceutical Form: Coated tablet
INN or Proposed INN: RISPERIDONE
CA
Sponsors
Academisch medisch centrum, department of psychiatry
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Eligible for the study are male in- and outpatients age 18 to 30 (extremes included), of diverse ethnicity, meeting DSM-IV criteria for schizophrenia, schizoaffective - or schizophreniform disorder and cannabis abuse or dependence based on the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID-P). Women will not be included because co-morbid cannabis abuse or dependence occurs more frequent in men and the expected number of included subjects, therefore, would not allow separate analysis. We will also include schizophrenia patients without cannabis abuse or dependence and compare their outcomes with those of patients with co-occurring cannabis abuse or dependence. We will also include healthy controls for 1 fMRI scan only. All patients need to be abstinent for cannabis use minimally three days before assessment of functional craving pathways. Each patient must understand the nature of the study and must sign an informed consent document. 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: Exclusion criteria are (1) known hypersensitivity to any ingredient of clozapine or risperidone, (2) concomitant use of any antipsychotic drug other than clozapine or risperidone, (3) use of depot antipsychotics in the three months prior to inclusion, (4) use of psychotropic medications other than oxazepam or biperiden, (5) narrow angle glaucoma, (6) known neurological or endocrine disease, (7) presence of non-removable metal objects (8) myeloproliferative disorders, (9) unstable epilepsy, (10) agranulocytosis or leucopenia in the past (11) Current leukocyte level lower than 3.5 x 109/l, current neutrophilic granulocyte level lower than 2.0x 109/l .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that clozapine treatment compared to risperidone treatment is associated with differences in functional craving pathways and their associated brain activity patterns related to reduction in subjective craving.;Secondary Objective: ;Primary end point(s): Main study parameter/endpoint Differences between the treatment conditions in pre-post treatment changes in brain activation during specific tests. Secondary study parameters/endpoints a. Subjective craving (VAS) b. Physiological cue reactivity: Heart rate variability and skin conductance c. Symptoms as assessed with PANSS, SWN and YBOCS | — |
Countries
Netherlands
Outcome results
None listed