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

Not Applicable
Completed
Conditions
Schizophrenia
Mental and Behavioural Disorders
Registration Number
ISRCTN27750123
Lead Sponsor
niversity of Cologne (Germany)
Brief Summary

2014 Results article in https://pubmed.ncbi.nlm.nih.gov/24628830/ (added 01/09/2021)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
30
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<br> 1. Amount of cannabis consumption 12 months after inclusion in the study<br> 2. Less side effects in ziprasidone group<br> 3. After 12 months:<br> 3.1. Better compliance in ziprasidone group<br> 3.2. Better course of schizophrenia within the ziprasidone group<br>
Secondary Outcome Measures
NameTimeMethod
<br> 1. Amount of cannabis consumption 3 and 6 months after inclusion in the study<br> 2. Others compared with primary outcomes just to 3 and 6 months<br>
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