ID

23073

Description

Randomized Evaluation of the Effectiveness of Clozapine and Aripiprazole Versus Clozapine and Haloperidol in the Treatment of Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00395915

Link

https://clinicaltrials.gov/show/NCT00395915

Keywords

Versions (1)
  1. 6/22/17 6/22/17 -
Uploaded on

June 22, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00395915

English

Eligibility Schizophrenia NCT00395915

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. current treatment with clozapine for the primary indication of schizophrenia (clinical diagnosis, guided by dsm-iv criteria).
Description

Clozapine | Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0009079
UMLS CUI [2]
C0036341
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.
Description

Clozapine | Dose Stable U/day | Dose Limited caused by Adverse effects

Data type

boolean

Alias
UMLS CUI [1]
C0009079
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0178602
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0015127
UMLS CUI [3,4]
C0879626
3. unsatisfactory benefit from clozapine treatment, as indicated by the presence of positive symptoms (delusions, hallucinations, abnormal behaviour, clinical diagnosis)
Description

Clozapine Benefit Unsatisfactory | Symptoms Positive Present | Delusions | Hallucinations | Abnormal behavior | Diagnosis, clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C0009079
UMLS CUI [1,2]
C0814225
UMLS CUI [1,3]
C0439856
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C0150312
UMLS CUI [3]
C0011253
UMLS CUI [4]
C0018524
UMLS CUI [5]
C0233514
UMLS CUI [6]
C0332140
4. age 18 and above.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. agreement between investigator and patient to enter the study.
Description

Study Subject Participation Status Agreement Investigator

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C4255373
UMLS CUI [1,3]
C0035173
6. the patient is normally resident in italy.
Description

Residence

Data type

boolean

Alias
UMLS CUI [1]
C0237096
7. it is considered clinically reasonable to try combination treatment with clozapine and aripiprazole or with clozapine and haloperidol.
Description

Combined Modality Therapy | Clozapine | aripiprazole | Haloperidol

Data type

boolean

Alias
UMLS CUI [1]
C0009429
UMLS CUI [2]
C0009079
UMLS CUI [3]
C0299792
UMLS CUI [4]
C0018546
8. uncertainty about which trial treatment would be best for the participant.
Description

Therapeutic procedure Uncertain

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0087130
9. no medical disorder or condition contraindicates either of the investigational drugs.
Description

Investigational New Drugs Medical contraindication Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0332197
10. agreement between investigator and patient to discontinue any antipsychotic drugs other than clozapine (including long-acting antipsychotic drugs).
Description

Antipsychotic Agents To be stopped | Antipsychotic Agents Active Long-term To be stopped | Clozapine Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C1272691
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C0205177
UMLS CUI [2,3]
C0443252
UMLS CUI [2,4]
C1272691
UMLS CUI [3,1]
C0009079
UMLS CUI [3,2]
C2828389
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Similar models

Eligibility Schizophrenia NCT00395915

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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