ID

15969

Descripción

Treatment of Social Cognition in Schizophrenia Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02246426

Link

https://clinicaltrials.gov/show/NCT02246426

Palabras clave

Versiones (1)
  1. 22/6/16 22/6/16 -
Subido en

22 de junio de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT02246426

Inglés

Eligibility Schizophrenia NCT02246426

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects must be at least 18 years old at the time of study screening
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. subjects must have a diagnosis of schizophrenia as defined by dsm-v129 criteria and confirmed by the structured clinical interview for dsm-iv (scid-p).
Descripción

Schizophrenia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036341
3. subjects must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study.
Descripción

Decision Capability | Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C2698977
UMLS CUI [2]
C2348568
4. subjects must have been clinically stable (non-acute) for 8 weeks prior to consent; in the judgment of the site principal investigator.
Descripción

Stable status Clinical

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205210
5. subjects must have been maintained on a stable treatment of antipsychotics and/or other concomitant psychotropic treatment for at least 6 weeks prior to consent.
Descripción

Antipsychotic Agents Therapeutic procedure Stable status | Therapeutic procedure Psychotropic Drugs concomitant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0033978
UMLS CUI [2,3]
C0521115
6. subjects must have learned english before the age of 12 to ensure valid neuropsychological results
Descripción

Learned English Language | Age | Neuropsychology Validity of Results

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023185
UMLS CUI [1,2]
C0376245
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0027903
UMLS CUI [3,2]
C0042284
7. subjects must have the visual, auditory, and motor capacity to use the computerized intervention in the judgment of the consenting study staff person.
Descripción

Capacity Visual | Capacity Auditory | motor ability | Intervention regimes Computer Systems

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516240
UMLS CUI [1,2]
C0234621
UMLS CUI [2,1]
C1516240
UMLS CUI [2,2]
C0439825
UMLS CUI [3]
C0260026
UMLS CUI [4,1]
C1273869
UMLS CUI [4,2]
C0009612
8. subjects must have no more than a moderate severity rating on hallucinations and unusual thought content as shown by a score of ≤ 4 on the positive and negative symptoms scale (panss).
Descripción

Hallucinations Moderate | Unusual Thought Content Moderate | Positive and negative syndrome scale

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018524
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C3639370
UMLS CUI [2,2]
C0205081
UMLS CUI [3]
C0451383
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects should not have had a psychiatric hospitalization in the 8 weeks prior to consent.
Descripción

psychiatric hospitalization

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0748061
2. subjects who appear to be intoxicated or under the influence of a controlled substance on any day of assessment must be rescheduled or discontinued based upon the discretion of the site staff evaluator.
Descripción

Intoxication | controlled substance Influence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0728899
UMLS CUI [2,1]
C0678485
UMLS CUI [2,2]
C4054723
3. subjects should not have a history of mental retardation (iq<70 based on wtar132) or pervasive developmental disorder; or other neurological disorder (e.g., traumatic brain injury, epilepsy, parkinson's disease.)
Descripción

Mental Retardation | Intelligence quotient | Pervasive Development Disorder | nervous system disorder | Traumatic Brain Injury | Epilepsy | Parkinson Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0025362
UMLS CUI [2]
C0456149
UMLS CUI [3]
C0524528
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0876926
UMLS CUI [6]
C0014544
UMLS CUI [7]
C0030567
4. subjects should not have been treated within 5 years of the date of consent with a computer-based cognitive training program manufactured by posit science.
Descripción

Computer-Assisted Cognitive Training

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3899511
5. subjects should not be participating in a concurrent clinical trial that, in the judgment of the site principal investigator, could affect the outcome of this one.
Descripción

Study Subject Participation Status | Clinical Trial Affecting research results

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0683954
6. subjects should not be prescribed more than two anti-psychotics. subjects should not be routinely treated with adjunctive medication with known significant anticholinergic side effects including diphenhydramine and/or benztropine.
Descripción

Antipsychotic Agents Quantity | adjunctive treatment Pharmaceutical Preparations Anticholinergic adverse reaction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C3858690
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0569703
7. subjects who have answered 'yes' to question 5 (active suicidal ideation with specific plan and intent) on the columbia-suicide severity rating scale, c-ssrs, or who have answered 'yes' to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the c-ssrs "suicidal behavior" portion shall be excluded from the study if ideation or behavior occurred within one month of consent. subjects excluded for this reason will be referred for appropriate treatment.
Descripción

Feeling suicidal | Columbia suicide severity rating scale | Suicidal behavior | Actual Suicide Attempt | Interrupted Suicide Attempt | Aborted Suicide Attempt | Preparatory actions toward imminent suicidal behavior

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C3888485
UMLS CUI [3]
C1760428
UMLS CUI [4]
C3639923
UMLS CUI [5]
C3639927
UMLS CUI [6]
C3639930
UMLS CUI [7]
C3267153
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Similar models

Eligibility Schizophrenia NCT02246426

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. subjects must be at least 18 years old at the time of study screening
boolean
C0001779 (UMLS CUI [1])
Schizophrenia
Item
2. subjects must have a diagnosis of schizophrenia as defined by dsm-v129 criteria and confirmed by the structured clinical interview for dsm-iv (scid-p).
boolean
C0036341 (UMLS CUI [1])
Decision Capability | Study Subject Participation Status
Item
3. subjects must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study.
boolean
C0679006 (UMLS CUI [1,1])
C2698977 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
Stable status Clinical
Item
4. subjects must have been clinically stable (non-acute) for 8 weeks prior to consent; in the judgment of the site principal investigator.
boolean
C0205360 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
Antipsychotic Agents Therapeutic procedure Stable status | Therapeutic procedure Psychotropic Drugs concomitant
Item
5. subjects must have been maintained on a stable treatment of antipsychotics and/or other concomitant psychotropic treatment for at least 6 weeks prior to consent.
boolean
C0040615 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0033978 (UMLS CUI [2,2])
C0521115 (UMLS CUI [2,3])
Learned English Language | Age | Neuropsychology Validity of Results
Item
6. subjects must have learned english before the age of 12 to ensure valid neuropsychological results
boolean
C0023185 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0027903 (UMLS CUI [3,1])
C0042284 (UMLS CUI [3,2])
Capacity Visual | Capacity Auditory | motor ability | Intervention regimes Computer Systems
Item
7. subjects must have the visual, auditory, and motor capacity to use the computerized intervention in the judgment of the consenting study staff person.
boolean
C1516240 (UMLS CUI [1,1])
C0234621 (UMLS CUI [1,2])
C1516240 (UMLS CUI [2,1])
C0439825 (UMLS CUI [2,2])
C0260026 (UMLS CUI [3])
C1273869 (UMLS CUI [4,1])
C0009612 (UMLS CUI [4,2])
Hallucinations Moderate | Unusual Thought Content Moderate | Positive and negative syndrome scale
Item
8. subjects must have no more than a moderate severity rating on hallucinations and unusual thought content as shown by a score of ≤ 4 on the positive and negative symptoms scale (panss).
boolean
C0018524 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C3639370 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0451383 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
psychiatric hospitalization
Item
1. subjects should not have had a psychiatric hospitalization in the 8 weeks prior to consent.
boolean
C0748061 (UMLS CUI [1])
Intoxication | controlled substance Influence
Item
2. subjects who appear to be intoxicated or under the influence of a controlled substance on any day of assessment must be rescheduled or discontinued based upon the discretion of the site staff evaluator.
boolean
C0728899 (UMLS CUI [1])
C0678485 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
Mental Retardation | Intelligence quotient | Pervasive Development Disorder | nervous system disorder | Traumatic Brain Injury | Epilepsy | Parkinson Disease
Item
3. subjects should not have a history of mental retardation (iq<70 based on wtar132) or pervasive developmental disorder; or other neurological disorder (e.g., traumatic brain injury, epilepsy, parkinson's disease.)
boolean
C0025362 (UMLS CUI [1])
C0456149 (UMLS CUI [2])
C0524528 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0876926 (UMLS CUI [5])
C0014544 (UMLS CUI [6])
C0030567 (UMLS CUI [7])
Computer-Assisted Cognitive Training
Item
4. subjects should not have been treated within 5 years of the date of consent with a computer-based cognitive training program manufactured by posit science.
boolean
C3899511 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trial Affecting research results
Item
5. subjects should not be participating in a concurrent clinical trial that, in the judgment of the site principal investigator, could affect the outcome of this one.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
Antipsychotic Agents Quantity | adjunctive treatment Pharmaceutical Preparations Anticholinergic adverse reaction
Item
6. subjects should not be prescribed more than two anti-psychotics. subjects should not be routinely treated with adjunctive medication with known significant anticholinergic side effects including diphenhydramine and/or benztropine.
boolean
C0040615 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3858690 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0569703 (UMLS CUI [2,3])
Feeling suicidal | Columbia suicide severity rating scale | Suicidal behavior | Actual Suicide Attempt | Interrupted Suicide Attempt | Aborted Suicide Attempt | Preparatory actions toward imminent suicidal behavior
Item
7. subjects who have answered 'yes' to question 5 (active suicidal ideation with specific plan and intent) on the columbia-suicide severity rating scale, c-ssrs, or who have answered 'yes' to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the c-ssrs "suicidal behavior" portion shall be excluded from the study if ideation or behavior occurred within one month of consent. subjects excluded for this reason will be referred for appropriate treatment.
boolean
C0424000 (UMLS CUI [1])
C3888485 (UMLS CUI [2])
C1760428 (UMLS CUI [3])
C3639923 (UMLS CUI [4])
C3639927 (UMLS CUI [5])
C3639930 (UMLS CUI [6])
C3267153 (UMLS CUI [7])
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