Efficacy and tolerability of ziprasidone versus clozapine in the treatment of dually diagnosed (DD-) patients with schizophrenia and cannabis use disorder: a randomised study

ISRCTN ISRCTN27750123
DOI https://doi.org/10.1186/ISRCTN27750123
Secondary identifying numbers EXPSY 0105
Submission date
07/12/2005
Registration date
20/01/2006
Last edited
01/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Euphrosyne Gouzoulis-Mayfrank
Scientific

University of Cologne
Department of Psychiatry and Psychotherapy
Kerpener Str. 62
Cologne
50937
Germany

Phone +49 (0)221 478 4825
Email e.gouzoulis@uni-koeln.de

Study information

Study designOpen, randomised, controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleEfficacy and tolerability of ziprasidone versus clozapine in the treatment of dually diagnosed (DD-) patients with schizophrenia and cannabis use disorder: a randomised study
Study objectivesNearly 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(s)The study received approval from the Ethics Committee on 01/12/2005.
Health condition(s) or problem(s) studiedSchizophrenia
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Ziprasidone, Clozapine
Primary outcome measure1. 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 measures1. 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 study start date01/01/2006
Completion date01/01/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants50 patients (25 ziprasidone; 25 Clozapine)
Total final enrolment30
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2006
Date of final enrolment01/01/2009

Locations

Countries of recruitment

  • Germany

Study participating centre

University of Cologne
Cologne
50937
Germany

Sponsor information

University of Cologne (Germany)
University/education

Department of Psychiatry and Psychotherapy
Kerpener Str. 62
Cologne
50937
Germany

Phone +49 (0)221 478 4825
Email e.gouzoulis@uni-koeln.de
ROR logo "ROR" https://ror.org/00rcxh774

Funders

Funder type

Industry

Pfizer Pharma GmbH (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 15/03/2014 01/09/2021 Yes No

Editorial Notes

01/09/2021: Publication reference and total final enrolment added.