Clozapine | Schizophrenia
Item
1. current treatment with clozapine for the primary indication of schizophrenia (clinical diagnosis, guided by dsm-iv criteria).
boolean
C0009079 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
Clozapine | Dose Stable U/day | Dose Limited caused by Adverse effects
Item
2. treatment with clozapine for at least six months at a stable dose of 400 mg or more per day, unless the size of the dose was limited by side-effects.
boolean
C0009079 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0178602 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0015127 (UMLS CUI [3,3])
C0879626 (UMLS CUI [3,4])
Clozapine Benefit Unsatisfactory | Symptoms Positive Present | Delusions | Hallucinations | Abnormal behavior | Diagnosis, clinical
Item
3. unsatisfactory benefit from clozapine treatment, as indicated by the presence of positive symptoms (delusions, hallucinations, abnormal behaviour, clinical diagnosis)
boolean
C0009079 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C0439856 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0150312 (UMLS CUI [2,3])
C0011253 (UMLS CUI [3])
C0018524 (UMLS CUI [4])
C0233514 (UMLS CUI [5])
C0332140 (UMLS CUI [6])
Age
Item
4. age 18 and above.
boolean
C0001779 (UMLS CUI [1])
Study Subject Participation Status Agreement Investigator
Item
5. agreement between investigator and patient to enter the study.
boolean
C2348568 (UMLS CUI [1,1])
C4255373 (UMLS CUI [1,2])
C0035173 (UMLS CUI [1,3])
Residence
Item
6. the patient is normally resident in italy.
boolean
C0237096 (UMLS CUI [1])
Combined Modality Therapy | Clozapine | aripiprazole | Haloperidol
Item
7. it is considered clinically reasonable to try combination treatment with clozapine and aripiprazole or with clozapine and haloperidol.
boolean
C0009429 (UMLS CUI [1])
C0009079 (UMLS CUI [2])
C0299792 (UMLS CUI [3])
C0018546 (UMLS CUI [4])
Therapeutic procedure Uncertain
Item
8. uncertainty about which trial treatment would be best for the participant.
boolean
C0087111 (UMLS CUI [1,1])
C0087130 (UMLS CUI [1,2])
Investigational New Drugs Medical contraindication Absent
Item
9. no medical disorder or condition contraindicates either of the investigational drugs.
boolean
C0013230 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Antipsychotic Agents To be stopped | Antipsychotic Agents Active Long-term To be stopped | Clozapine Excluded
Item
10. agreement between investigator and patient to discontinue any antipsychotic drugs other than clozapine (including long-acting antipsychotic drugs).
boolean
C0040615 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0040615 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0443252 (UMLS CUI [2,3])
C1272691 (UMLS CUI [2,4])
C0009079 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])