ID

37177

Descripción

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

Link

https://clinicaltrials.gov/show/NCT02435095

Palabras clave

Versiones (1)
  1. 6/7/19 6/7/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

6 de julio de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT02435095

Inglés

Eligibility Schizophrenia NCT02435095

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

First episode Schizophrenia

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

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

Informed Consent

Tipo de datos

boolean

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

Comprehension Instructions Research Personnel | Adherence Instructions Research Personnel

Tipo de datos

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
Descripción

Study Subject Eligible Magnetic Resonance Imaging

Tipo de datos

boolean

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

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)
Descripción

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

Tipo de datos

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
Descripción

Antipsychotic drug therapy Previous

Tipo de datos

boolean

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

Metallic material Magnetic Body | Artificial cardiac pacemaker | Piercing

Tipo de datos

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
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

Institutionalized Person

Tipo de datos

boolean

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

Dependency Investigator | Working Relationship Investigator

Tipo de datos

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
Descripción

Study Subject Participation Status | Interventional Study

Tipo de datos

boolean

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

Eligibility Schizophrenia NCT02435095

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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