ID

22752

Description

Amisulpride Augmentation Therapy for Clozapine-resistant Schizophrenic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01105481

Link

https://clinicaltrials.gov/show/NCT01105481

Keywords

Versions (1)
  1. 6/11/17 6/11/17 -
Uploaded on

June 11, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Treatment-resistant Schizophrenia NCT01105481

English

Eligibility Treatment-resistant Schizophrenia NCT01105481

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
dsm-iv diagnosed schizophrenic patients;
Description

schizophrenia dsm iv

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0220952
age between 18 and 60;
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
before treatment with clozapine, documented treatment failure of two antipsychotics for an adequate duration of 6 weeks and in a sufficient dose of 600 mg/day of chlorpromazine equivalents;
Description

prior therapy non-responder

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0205269
documented failure to show a satisfactory clinical response to an adequate clozapine treatment, defined as at least clozapine 300 mg/day for 3 months or a plasma drug level of 350ng/ml;
Description

failure to show a satisfactory clinical response to clozapine

Data type

boolean

Alias
UMLS CUI [1,1]
C0009079
UMLS CUI [1,2]
C0205269
at least moderately ill, defined as with a clinical global impression (cgi) greater than 4 or panss total score greater than 75;
Description

clinical global impression, panss

Data type

boolean

Alias
UMLS CUI [1,1]
C3639708
UMLS CUI [1,2]
C0521117
UMLS CUI [2]
C0451383
persistent positive psychotic symptoms, with rating scores of moderate or worse on at least two of four positive symptom items (delusion, conceptual disorganization, hallucinatory behavior, and suspiciousness/persecution) on positive and negative syndrome scale (panss);
Description

positive psychotic symptoms on panss

Data type

boolean

Alias
UMLS CUI [1,1]
C1446409
UMLS CUI [1,2]
C0871189
UMLS CUI [1,3]
C0439793
UMLS CUI [1,4]
C0451383
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with concomitant treatment with lithium, anti-convulsants, antidepressants and other antipsychotic medication ;
Description

concomitant treatment with lithium, anti-convulsants, antidepressants and other antipsychotic medication ;

Data type

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C0023870
UMLS CUI [2,1]
C1707479
UMLS CUI [2,2]
C0003286
UMLS CUI [3,1]
C1707479
UMLS CUI [3,2]
C0003289
UMLS CUI [4,1]
C1707479
UMLS CUI [4,2]
C0040615
patients with underlying severe medical illness, such as cardiovascular disease, cerebrovascular disease, bone marrow suppression or epilepsy;
Description

severe comorbidity, cardiovascular disease, cerebrovascular disease, bone marrow suppression, epilepsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0007820
UMLS CUI [4]
C0280962
UMLS CUI [5]
C0014544
patients with comorbid diagnosis of substance dependence;
Description

substance use disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
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Similar models

Eligibility Treatment-resistant Schizophrenia NCT01105481

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
schizophrenia dsm iv
Item
dsm-iv diagnosed schizophrenic patients;
boolean
C0036341 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
age
Item
age between 18 and 60;
boolean
C0001779 (UMLS CUI [1])
prior therapy non-responder
Item
before treatment with clozapine, documented treatment failure of two antipsychotics for an adequate duration of 6 weeks and in a sufficient dose of 600 mg/day of chlorpromazine equivalents;
boolean
C1514463 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
failure to show a satisfactory clinical response to clozapine
Item
documented failure to show a satisfactory clinical response to an adequate clozapine treatment, defined as at least clozapine 300 mg/day for 3 months or a plasma drug level of 350ng/ml;
boolean
C0009079 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
clinical global impression, panss
Item
at least moderately ill, defined as with a clinical global impression (cgi) greater than 4 or panss total score greater than 75;
boolean
C3639708 (UMLS CUI [1,1])
C0521117 (UMLS CUI [1,2])
C0451383 (UMLS CUI [2])
positive psychotic symptoms on panss
Item
persistent positive psychotic symptoms, with rating scores of moderate or worse on at least two of four positive symptom items (delusion, conceptual disorganization, hallucinatory behavior, and suspiciousness/persecution) on positive and negative syndrome scale (panss);
boolean
C1446409 (UMLS CUI [1,1])
C0871189 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,3])
C0451383 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
concomitant treatment with lithium, anti-convulsants, antidepressants and other antipsychotic medication ;
Item
patients with concomitant treatment with lithium, anti-convulsants, antidepressants and other antipsychotic medication ;
boolean
C1707479 (UMLS CUI [1,1])
C0023870 (UMLS CUI [1,2])
C1707479 (UMLS CUI [2,1])
C0003286 (UMLS CUI [2,2])
C1707479 (UMLS CUI [3,1])
C0003289 (UMLS CUI [3,2])
C1707479 (UMLS CUI [4,1])
C0040615 (UMLS CUI [4,2])
severe comorbidity, cardiovascular disease, cerebrovascular disease, bone marrow suppression, epilepsy
Item
patients with underlying severe medical illness, such as cardiovascular disease, cerebrovascular disease, bone marrow suppression or epilepsy;
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0007820 (UMLS CUI [3])
C0280962 (UMLS CUI [4])
C0014544 (UMLS CUI [5])
substance use disorder
Item
patients with comorbid diagnosis of substance dependence;
boolean
C0038586 (UMLS CUI [1])
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