Patients with schizophrenia and cannabis abuse/dependency will be randomized to ziprasidone or clozapine treatment. Dose of medication and frequency of administration will be flexible and adjustable depending on clinical requirements. Duration of therapeutic trial:12 months
Conditions
Interventions
Trade Name: Zeldox(R), 20 mg Hartkapseln
Product Name: Ziprasidon HCl 20 mg Capsules
Product Code: Zeldox
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ziprasidon
Concentration unit: mg mill
Sponsors
Department of Psychiatry and Psychotherapy (Cologne)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with schizophrenia, schizophreniform or schizoaffective disorder according to DSM-IV (295.xx) and 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, F12.2) 2. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Further 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 evaluations 5. No compliance with the requirements of the study / lack of or questionable capability of giving informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Duration of the study: overall 3 years Primary end point is month 36 (final data analyses) after the last follow-up in month 35.;Main Objective: To compare the effectiveness and tolerability of the atypical antipsychotics ziprasidone (Zeldox®) and clozapine (Leponex®) in a randomised design with comorbid patients with schizophrenia and cannabis abuse or dependence. Primary hypothesis: Patients with schizophrenia and cannabis abuse/dependency who are randomized to ziprasidone (ziprasidone group) do not use cannabis more frequently and/or more heavily than patients who are randomized to clozapine (clozapine group). ;Secondary Objective: - the ziprasidone group reports less medication side effects than the clozapine group - the ziprasidone group has a better compliance with antipsychotic medication and psychiatric treatment compared to the clozapine group - the ziprasidone group does not differ from the clozapine group in terms of the treatment course (no differences in relapse and rehospitalisation) - the ziprasidone group does not differ from the clozapine group in terms of psychopathology (positive and negative symptoms, general psychopathology) and global functioning | — |
Countries
Germany
Outcome results
None listed