ID

19352

Description

Antipsychotic Therapy and First Episode; ODM derived from: https://clinicaltrials.gov/show/NCT00334035

Link

https://clinicaltrials.gov/show/NCT00334035

Keywords

Versions (1)
  1. 12/20/16 12/20/16 -
Uploaded on

December 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00334035

English

Eligibility Schizophrenia NCT00334035

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients, from 18 to 65 years of age at visit 1
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must achieve a level of understanding and expressive capacity sufficient to communicate adequately with the study coordinator and to participate in cognitive testing.
Description

Able to communicate Study Coordinator | Participation Testing Cognitive

Data type

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C1710220
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0039593
UMLS CUI [2,3]
C1516691
patients must agree to cooperate with all tests and examinations required by the protocol. they must be willing to comply fully with treatment
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
patient must understand the nature of the study and must sign an informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients must be cantonese speaking han chinese
Description

Able to speak Cantonese Chinese dialect

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0682397
patients must be diagnosed, according to the scid for dsm-iv, with schizophrenia, schizoaffective disorder or schizophreniform psychosis.
Description

Schizophrenia | Schizoaffective Disorder | psychosis; schizophreniform

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
UMLS CUI [3]
C0865304
patients must have good response to anti-psychotic treatment by achieving a rating of 2 or below in clinical global impression scale (cgi) severity of illness; a rating of 4 or below in improvement scale, and a rating of 3 or below in (conceptual disorganization, unusual thought content), a rating of 2 or below in (delusion, hallucinatory behavior) and a rating of 4 or below in (suspiciousness) of positive and negative syndrome scale (panss) for at least 8 weeks
Description

Antipsychotic drug therapy Good therapeutic response | Clinical Global Impression Questionnaire | Improvement rating scale | Conceptual Disorganization | Unusual Thought Content | Delusions | Hallucinatory Behavior | Suspicious behavior | Positive and negative syndrome scale

Data type

boolean

Alias
UMLS CUI [1,1]
C1319421
UMLS CUI [1,2]
C0184785
UMLS CUI [2]
C3639708
UMLS CUI [3,1]
C2986411
UMLS CUI [3,2]
C0681889
UMLS CUI [4]
C3639359
UMLS CUI [5]
C3639370
UMLS CUI [6]
C0011253
UMLS CUI [7]
C3639367
UMLS CUI [8]
C0233519
UMLS CUI [9]
C0451383
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female patients who are either pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients previously on clozapine should be excluded from the study
Description

Clozapine

Data type

boolean

Alias
UMLS CUI [1]
C0009079
significant medical illnesses including seizures.
Description

Illness Significant | Seizures

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0036572
dsm-iv substance (alcohol or other drugs) abuse or dependence within the past 3 months.
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
judged clinically to be at serious suicidal risk.
Description

At risk for suicide Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
treatment with an injectable depot neuroleptic within less than one of the patient's dosing intervals between depot neuroleptic injections prior to study entry.
Description

Injection of depot antipsychotic agent

Data type

boolean

Alias
UMLS CUI [1]
C2585377
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Similar models

Eligibility Schizophrenia NCT00334035

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients, from 18 to 65 years of age at visit 1
boolean
C0001779 (UMLS CUI [1])
Able to communicate Study Coordinator | Participation Testing Cognitive
Item
patients must achieve a level of understanding and expressive capacity sufficient to communicate adequately with the study coordinator and to participate in cognitive testing.
boolean
C2364293 (UMLS CUI [1,1])
C1710220 (UMLS CUI [1,2])
C0679823 (UMLS CUI [2,1])
C0039593 (UMLS CUI [2,2])
C1516691 (UMLS CUI [2,3])
Protocol Compliance
Item
patients must agree to cooperate with all tests and examinations required by the protocol. they must be willing to comply fully with treatment
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
patient must understand the nature of the study and must sign an informed consent document.
boolean
C0021430 (UMLS CUI [1])
Able to speak Cantonese Chinese dialect
Item
patients must be cantonese speaking han chinese
boolean
C0564215 (UMLS CUI [1,1])
C0682397 (UMLS CUI [1,2])
Schizophrenia | Schizoaffective Disorder | psychosis; schizophreniform
Item
patients must be diagnosed, according to the scid for dsm-iv, with schizophrenia, schizoaffective disorder or schizophreniform psychosis.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0865304 (UMLS CUI [3])
Antipsychotic drug therapy Good therapeutic response | Clinical Global Impression Questionnaire | Improvement rating scale | Conceptual Disorganization | Unusual Thought Content | Delusions | Hallucinatory Behavior | Suspicious behavior | Positive and negative syndrome scale
Item
patients must have good response to anti-psychotic treatment by achieving a rating of 2 or below in clinical global impression scale (cgi) severity of illness; a rating of 4 or below in improvement scale, and a rating of 3 or below in (conceptual disorganization, unusual thought content), a rating of 2 or below in (delusion, hallucinatory behavior) and a rating of 4 or below in (suspiciousness) of positive and negative syndrome scale (panss) for at least 8 weeks
boolean
C1319421 (UMLS CUI [1,1])
C0184785 (UMLS CUI [1,2])
C3639708 (UMLS CUI [2])
C2986411 (UMLS CUI [3,1])
C0681889 (UMLS CUI [3,2])
C3639359 (UMLS CUI [4])
C3639370 (UMLS CUI [5])
C0011253 (UMLS CUI [6])
C3639367 (UMLS CUI [7])
C0233519 (UMLS CUI [8])
C0451383 (UMLS CUI [9])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
female patients who are either pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Clozapine
Item
patients previously on clozapine should be excluded from the study
boolean
C0009079 (UMLS CUI [1])
Illness Significant | Seizures
Item
significant medical illnesses including seizures.
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0036572 (UMLS CUI [2])
Substance Use Disorders | Substance Dependence
Item
dsm-iv substance (alcohol or other drugs) abuse or dependence within the past 3 months.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
At risk for suicide Serious
Item
judged clinically to be at serious suicidal risk.
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Injection of depot antipsychotic agent
Item
treatment with an injectable depot neuroleptic within less than one of the patient's dosing intervals between depot neuroleptic injections prior to study entry.
boolean
C2585377 (UMLS CUI [1])
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