Contact information
Type
Scientific
Primary contact
Prof Euphrosyne Gouzoulis-Mayfrank
ORCID ID
Contact details
University of Cologne
Department of Psychiatry and Psychotherapy
Kerpener Str. 62
Cologne
50937
Germany
+49 (0)221 478 4825
e.gouzoulis@uni-koeln.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EXPSY 0105
Study information
Scientific title
Acronym
Study hypothesis
Nearly 50% of schizophrenic patients fulfill the criteria of a coexisting substance abuse/dependence. Cannabis is the number one within the illicit drugs. It is shown that cannabis-abuse is associated with higher rates of relapse, less compliance with the therapy and high rates of suicidal behaviour.
Hypothesis:
Patients with schizophrenia and cannabis abuse/dependency who are randomised to ziprasidone (ziprasidone group) do not use cannabis more frequently and/or more heavily than patients who are randomised to clozapine (clozapine group).
Ethics approval
The study received approval from the Ethics Committee on 01/12/2005.
Study design
Open, randomised, controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Schizophrenia
Intervention
Patients will be randomised to either the ziprasidone or clozapine group. After 3, 6 and 12 months, we evaluate the possible effects on the course of schizophrenia and the consumption of cannabis. Moreover, all patients will get psychiatric/psychotherapeutic and sociorehabilitative elements.
Intervention type
Drug
Phase
Not Specified
Drug names
Ziprasidone, Clozapine
Primary outcome measure
1. Amount of cannabis consumption 12 months after inclusion in the study
2. Less side effects in ziprasidone group
3. After 12 months:
3.1. Better compliance in ziprasidone group
3.2. Better course of schizophrenia within the ziprasidone group
Secondary outcome measures
1. Amount of cannabis consumption 3 and 6 months after inclusion in the study
2. Others compared with primary outcomes just to 3 and 6 months
Overall trial start date
01/01/2006
Overall trial end date
01/01/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with schizophrenia, schizophreniform or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (295.xx) and International Statistical Classification of Diseases and Related Health Problems - tenth revision (ICD-10) (F20, F23.2, F25) as well as cannabis abuse or dependence according to DSM-IV (305.20, 304.30) and ICD-10 (F12.1, 12.2)
2. Capable of giving written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50 patients (25 ziprasidone; 25 Clozapine)
Participant exclusion criteria
1. Other relevant neuropsychiatric disorders
2. Prominent (acute) positive symptoms at the timepoint of inclusion
3. Previous treatments with ziprasidone or clozapine with significant side effects
4. No availability of a family member or significant other for the collateral interviews of the follow-up evaluation
5. No compliance with the requirements of the study/lack of or questionable capability of giving informed consent
Recruitment start date
01/01/2006
Recruitment end date
01/01/2009
Locations
Countries of recruitment
Germany
Trial participating centre
University of Cologne
Cologne
50937
Germany
Sponsor information
Organisation
University of Cologne (Germany)
Sponsor details
Department of Psychiatry and Psychotherapy
Kerpener Str. 62
Cologne
50937
Germany
+49 (0)221 478 4825
e.gouzoulis@uni-koeln.de
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Pfizer Pharma GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list