Effect of different antipsychotic medications on craving and craving related brain activity in patients with schizophrenia and cannabis abuse or dependence: a randomized controlled study comparing clozapine and risperidone

Phase 3

• Conditions: verslaving; psychotic disorders; schizophrenia; 10039628

• Registration Number: NL-OMON32193
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 70

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.
A group of healthy, matched controls will be included to get information on brain activation patterns associated with specific cognitive tasks in antipsychotic-naïve healthy controls. These controls are included to make a comparison with patients with schizophrenia who have been treated with antipsychotics for 4 weeks.
All patients need to be abstinent for cannabis use minimally three days before assessment of functional craving pathways

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 is lower than 3.5 x 109/l, current
neutrophilic granulocyte level is lower than 2.0x 109/l

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Differences between the treatment conditions in pre-post treatment changes in<br /><br>craving related brain activity are the primary outcome measure. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-</p><br>