Effect of different antipsychotic medication on craving related brain activity in patients with schizophrenia and cannabis abuse or dependence:a randomized controlled study comparing clozapine and risperidone. - fMRI.Clozapine.Risperidon.Cannabis
- Conditions
- 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.
- Registration Number
- EUCTR2008-003623-23-NL
- Lead Sponsor
- Academisch medisch centrum, department of psychiatry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
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 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 .
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method