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
Scientific
University of Cologne
Department of Psychiatry and Psychotherapy
Kerpener Str. 62
Cologne
50937
Germany
| Phone | +49 (0)221 478 4825 |
|---|---|
| e.gouzoulis@uni-koeln.de |
Study information
| Study design | Open, randomised, controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Efficacy and tolerability of ziprasidone versus clozapine in the treatment of dually diagnosed (DD-) patients with schizophrenia and cannabis use disorder: a randomised study |
| Study objectives | 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(s) | The study received approval from the Ethics Committee on 01/12/2005. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2006 |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target number of participants | 50 patients (25 ziprasidone; 25 Clozapine) |
| Total final enrolment | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
University of Cologne
Cologne
50937
Germany
50937
Germany
Sponsor information
University of Cologne (Germany)
University/education
University/education
Department of Psychiatry and Psychotherapy
Kerpener Str. 62
Cologne
50937
Germany
| Phone | +49 (0)221 478 4825 |
|---|---|
| e.gouzoulis@uni-koeln.de | |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
