Condition category
Mental and Behavioural Disorders
Date applied
07/12/2005
Date assigned
20/01/2006
Last edited
21/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes