ID

32094

Beskrivning

A Single-Center, Double-Blind (DB) Study of MEM 3454 on P50 Sensory Gating and Mismatch Negativity in Schizophrenia Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00725855

Länk

https://clinicaltrials.gov/show/NCT00725855

Nyckelord

Versioner (1)
  1. 2018-10-17 2018-10-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00725855

Engelsk

Eligibility Schizophrenia NCT00725855

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female subjects between 18and 55 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. fluent in english, even if english is not the primary language.
Beskrivning

Able to speak fluently English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0376245
3. able to provide informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
4. dsm iv-r primary diagnosis of schizophrenia (any subtype), assessed using a structured diagnostic interview (scid ct).
Beskrivning

Schizophrenia Subtype Any

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0449560
UMLS CUI [1,3]
C1552551
5. few or no extra-pyramidal symptoms(eps)at screening,defined as sas < 6.
Beskrivning

Extrapyramidal sign Few | Extrapyramidal sign Absent | Rating scale Extrapyramidal tract Side effects

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0234133
UMLS CUI [1,2]
C0205388
UMLS CUI [2,1]
C0234133
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0681889
UMLS CUI [3,2]
C0015372
UMLS CUI [3,3]
C0879626
6. negative urine drug screen (uds).
Beskrivning

Urine drug screen negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0920168
7. negative cotinine test.
Beskrivning

Urine cotinine test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C1696067
8. clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks. at least one month on the same dose of antipsychotic medication.
Beskrivning

Clinical status Stable | Acute phase Absent | Antipsychotic Agents Dose Same

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449440
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0439557
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0040615
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0445247
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
current risk of suicide, or history of suicidal behavior within the last 6 months.
Beskrivning

At risk for suicide | Suicidal behavior

Datatyp

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2]
C1760428
hospitalized for psychiatric symptoms in the past 3 months.
Beskrivning

Hospitalization Psychiatric symptoms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0233401
other psychiatric diagnoses.
Beskrivning

Psychiatric Diagnosis Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0376338
UMLS CUI [1,2]
C0205394
substance abuse/dependence (other than nicotine or caffeine) within the last 6 months according to the scid-ct.
Beskrivning

Substance Use Disorders | Substance Dependence | Exception Nicotine Dependence | Exception Caffeine dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0028043
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1386553
currently smoking, nicotine replacement therapy, smoking cessation medications or remedies, including varenicline (chantix).
Beskrivning

Tobacco use | Nicotine replacement therapy | Smoking cessation drug therapy | varenicline | Chantix

Datatyp

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C1278444
UMLS CUI [3]
C4075828
UMLS CUI [4]
C1569608
UMLS CUI [5]
C1712042
any medical condition, as judged by the investigator, which may interfere with the subjects' participation in this study.
Beskrivning

Medical condition Interferes with Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
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Similar models

Eligibility Schizophrenia NCT00725855

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female subjects between 18and 55 years of age.
boolean
C0001779 (UMLS CUI [1])
Able to speak fluently English Language
Item
2. fluent in english, even if english is not the primary language.
boolean
C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Informed Consent
Item
3. able to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Schizophrenia Subtype Any
Item
4. dsm iv-r primary diagnosis of schizophrenia (any subtype), assessed using a structured diagnostic interview (scid ct).
boolean
C0036341 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Extrapyramidal sign Few | Extrapyramidal sign Absent | Rating scale Extrapyramidal tract Side effects
Item
5. few or no extra-pyramidal symptoms(eps)at screening,defined as sas < 6.
boolean
C0234133 (UMLS CUI [1,1])
C0205388 (UMLS CUI [1,2])
C0234133 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0681889 (UMLS CUI [3,1])
C0015372 (UMLS CUI [3,2])
C0879626 (UMLS CUI [3,3])
Urine drug screen negative
Item
6. negative urine drug screen (uds).
boolean
C0920168 (UMLS CUI [1])
Urine cotinine test negative
Item
7. negative cotinine test.
boolean
C1696067 (UMLS CUI [1])
Clinical status Stable | Acute phase Absent | Antipsychotic Agents Dose Same
Item
8. clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks. at least one month on the same dose of antipsychotic medication.
boolean
C0449440 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0439557 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0040615 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0445247 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
At risk for suicide | Suicidal behavior
Item
current risk of suicide, or history of suicidal behavior within the last 6 months.
boolean
C0563664 (UMLS CUI [1])
C1760428 (UMLS CUI [2])
Hospitalization Psychiatric symptoms
Item
hospitalized for psychiatric symptoms in the past 3 months.
boolean
C0019993 (UMLS CUI [1,1])
C0233401 (UMLS CUI [1,2])
Psychiatric Diagnosis Other
Item
other psychiatric diagnoses.
boolean
C0376338 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Substance Use Disorders | Substance Dependence | Exception Nicotine Dependence | Exception Caffeine dependence
Item
substance abuse/dependence (other than nicotine or caffeine) within the last 6 months according to the scid-ct.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0028043 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1386553 (UMLS CUI [4,2])
Tobacco use | Nicotine replacement therapy | Smoking cessation drug therapy | varenicline | Chantix
Item
currently smoking, nicotine replacement therapy, smoking cessation medications or remedies, including varenicline (chantix).
boolean
C0543414 (UMLS CUI [1])
C1278444 (UMLS CUI [2])
C4075828 (UMLS CUI [3])
C1569608 (UMLS CUI [4])
C1712042 (UMLS CUI [5])
Medical condition Interferes with Study Subject Participation Status
Item
any medical condition, as judged by the investigator, which may interfere with the subjects' participation in this study.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
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