ID

37177

Description

Antipsychotic Induced Structural and Functional Brain Changes; ODM derived from: https://clinicaltrials.gov/show/NCT02435095

Link

https://clinicaltrials.gov/show/NCT02435095

Keywords

Versions (1)
  1. 7/6/19 7/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 6, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT02435095

English

Eligibility Schizophrenia NCT02435095

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with first-episode of schizophrenia according to dsm-v
Description

First episode Schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0439615
UMLS CUI [1,2]
C0036341
aged between18 and 65 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent prior to study participation
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
subjects who are contractually capable and mentally able to understand and follow the instructions of the study personnel
Description

Comprehension Instructions Research Personnel | Adherence Instructions Research Personnel

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C1442085
UMLS CUI [1,3]
C0035173
UMLS CUI [2,1]
C1510802
UMLS CUI [2,2]
C1442085
UMLS CUI [2,3]
C0035173
subjects eligible for mri
Description

Study Subject Eligible Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0024485
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the subject has a history of any other illness, which, in the opinion of the investigator, might have an effect on the study performance (e.g. malignant disease, epilepsia)
Description

Other medical condition Effect Completion of clinical trial | Malignant disease | Epilepsy

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C2732579
UMLS CUI [2]
C0442867
UMLS CUI [3]
C0014544
previous treatment with antipsychotics prior to study participation
Description

Antipsychotic drug therapy Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1319421
UMLS CUI [1,2]
C0205156
magnetizable metal parts in or at the body, pacemakers, piercings
Description

Metallic material Magnetic Body | Artificial cardiac pacemaker | Piercing

Data type

boolean

Alias
UMLS CUI [1,1]
C0567346
UMLS CUI [1,2]
C0563532
UMLS CUI [1,3]
C0460148
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0848128
pregnant and lactating females
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subject has been committed to an institution by legal or regulatory order
Description

Institutionalized Person

Data type

boolean

Alias
UMLS CUI [1]
C0376326
dependency or working relationship with the investigator
Description

Dependency Investigator | Working Relationship Investigator

Data type

boolean

Alias
UMLS CUI [1,1]
C0011546
UMLS CUI [1,2]
C0035173
UMLS CUI [2,1]
C0043227
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0035173
participation in a parallel interventional clinical study
Description

Study Subject Participation Status | Interventional Study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
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Similar models

Eligibility Schizophrenia NCT02435095

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
First episode Schizophrenia
Item
patients with first-episode of schizophrenia according to dsm-v
boolean
C0439615 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
Age
Item
aged between18 and 65 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
written informed consent prior to study participation
boolean
C0021430 (UMLS CUI [1])
Comprehension Instructions Research Personnel | Adherence Instructions Research Personnel
Item
subjects who are contractually capable and mentally able to understand and follow the instructions of the study personnel
boolean
C0162340 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
C0035173 (UMLS CUI [1,3])
C1510802 (UMLS CUI [2,1])
C1442085 (UMLS CUI [2,2])
C0035173 (UMLS CUI [2,3])
Study Subject Eligible Magnetic Resonance Imaging
Item
subjects eligible for mri
boolean
C0681850 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Other medical condition Effect Completion of clinical trial | Malignant disease | Epilepsy
Item
the subject has a history of any other illness, which, in the opinion of the investigator, might have an effect on the study performance (e.g. malignant disease, epilepsia)
boolean
C3843040 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0442867 (UMLS CUI [2])
C0014544 (UMLS CUI [3])
Antipsychotic drug therapy Previous
Item
previous treatment with antipsychotics prior to study participation
boolean
C1319421 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Metallic material Magnetic Body | Artificial cardiac pacemaker | Piercing
Item
magnetizable metal parts in or at the body, pacemakers, piercings
boolean
C0567346 (UMLS CUI [1,1])
C0563532 (UMLS CUI [1,2])
C0460148 (UMLS CUI [1,3])
C0030163 (UMLS CUI [2])
C0848128 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant and lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Institutionalized Person
Item
subject has been committed to an institution by legal or regulatory order
boolean
C0376326 (UMLS CUI [1])
Dependency Investigator | Working Relationship Investigator
Item
dependency or working relationship with the investigator
boolean
C0011546 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0043227 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0035173 (UMLS CUI [2,3])
Study Subject Participation Status | Interventional Study
Item
participation in a parallel interventional clinical study
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
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