ID

19364

Description

Modafinil Augmentation Therapy for Excessive Daytime Sleepiness and Negative Symptoms in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00546403

Link

https://clinicaltrials.gov/show/NCT00546403

Keywords

Versions (2)
  1. 12/21/16 12/21/16 -
  2. 12/22/16 12/22/16 -
Uploaded on

December 21, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Schizophrenia NCT00546403

English

Eligibility Schizophrenia NCT00546403

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must be able to communicate and give voluntary informed consent
Description

Able to communicate | Informed Consent Voluntary

Data type

boolean

Alias
UMLS CUI [1]
C2364293
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0439656
subjects must be of the male gender
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
between the ages of 18 to 65 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
a diagnosis of schizophrenia or schizoaffective disorder as determined by dsm-iv criteria.
Description

Schizophrenia | Schizoaffective Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
not conservatorized
Description

Legal Guardian Without

Data type

boolean

Alias
UMLS CUI [1,1]
C0023226
UMLS CUI [1,2]
C0332288
a negative symptom score on the panss of >= 20 and an mmse score of >24
Description

Symptoms Negative Positive and negative syndrome scale | Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C0451383
UMLS CUI [2]
C0451306
no clinical evidence of a current unstable medical illness
Description

Illness Unstable Evidence

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C3887511
no current clinical evidence or past history of cerebral neurological impairment (including strokes, tumors or trauma leading to loss of consciousness)
Description

Nervous system disorder cerebral | Cerebrovascular accident | Brain Neoplasms | Traumatic Brain Injury Resulting in Unconscious State

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0006104
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0006118
UMLS CUI [4,1]
C0876926
UMLS CUI [4,2]
C0332294
UMLS CUI [4,3]
C0041657
no history of drug or alcohol dependence in the past 2 years
Description

Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
no evidence of drug or alcohol abuse in the past year, as determined by the dsm-iv criteria.
Description

Substance Use Disorders Evidence

Data type

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C3887511
no diagnosis of narcolepsy as determined by dsm-iv criteria
Description

Narcolepsy

Data type

boolean

Alias
UMLS CUI [1]
C0027404
must have an approved contact person for the duration of the study
Description

Contact person Approved

Data type

boolean

Alias
UMLS CUI [1,1]
C0337611
UMLS CUI [1,2]
C0205540
may be on a stable dose of ssri for depressive symptoms
Description

Selective Serotonin Reuptake Inhibitors Depressive Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0360105
UMLS CUI [1,2]
C0086132
no history of aggression
Description

Aggressive behavior

Data type

boolean

Alias
UMLS CUI [1]
C0001807
no uncontrolled hypertension, as defined below (subjects cannot have any of the following):
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
1. a new diagnosis of hypertension, or
Description

Hypertensive disease New diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C2585997
2. a change in antihypertensive medications in the past 30 days, or
Description

Antihypertensive Agents Change

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0392747
3. acute hypertension (systolic>160mmhg, diastolic>100mmhg)
Description

Hypertensive disease | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
maybe on a stable dose of a benzodiazepine
Description

Benzodiazepines Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0005064
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
the following medications will not be allowed during the study- methylphenidate, amphetamines, pemoline, zolpidem, mao inhibitors, anticoagulant, tca's, or barbiturates.
Description

Methylphenidate | Amphetamines | Pemoline | zolpidem | Monoamine Oxidase Inhibitors | Anticoagulants | Tricarboxylic Acids | Barbiturates

Data type

boolean

Alias
UMLS CUI [1]
C0025810
UMLS CUI [2]
C0002667
UMLS CUI [3]
C0030800
UMLS CUI [4]
C0078839
UMLS CUI [5]
C0026457
UMLS CUI [6]
C0003280
UMLS CUI [7]
C0040887
UMLS CUI [8]
C0004745
be on a stable does of an atypical neuroleptic
Description

Atypical antipsychotic Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C1276996
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
may be on a stable does of an anticonvulsant for mood stabilization
Description

Anticonvulsants Mood Stabilization

Data type

boolean

Alias
UMLS CUI [1,1]
C0003286
UMLS CUI [1,2]
C0026516
UMLS CUI [1,3]
C1293130
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects cannot be female.
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
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Similar models

Eligibility Schizophrenia NCT00546403

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Able to communicate | Informed Consent Voluntary
Item
subjects must be able to communicate and give voluntary informed consent
boolean
C2364293 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0439656 (UMLS CUI [2,2])
Gender
Item
subjects must be of the male gender
boolean
C0079399 (UMLS CUI [1])
Age
Item
between the ages of 18 to 65 years.
boolean
C0001779 (UMLS CUI [1])
Schizophrenia | Schizoaffective Disorder
Item
a diagnosis of schizophrenia or schizoaffective disorder as determined by dsm-iv criteria.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
Legal Guardian Without
Item
not conservatorized
boolean
C0023226 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
Symptoms Negative Positive and negative syndrome scale | Mini-mental state examination
Item
a negative symptom score on the panss of >= 20 and an mmse score of >24
boolean
C1457887 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0451383 (UMLS CUI [1,3])
C0451306 (UMLS CUI [2])
Illness Unstable Evidence
Item
no clinical evidence of a current unstable medical illness
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C3887511 (UMLS CUI [1,3])
Nervous system disorder cerebral | Cerebrovascular accident | Brain Neoplasms | Traumatic Brain Injury Resulting in Unconscious State
Item
no current clinical evidence or past history of cerebral neurological impairment (including strokes, tumors or trauma leading to loss of consciousness)
boolean
C0027765 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2])
C0006118 (UMLS CUI [3])
C0876926 (UMLS CUI [4,1])
C0332294 (UMLS CUI [4,2])
C0041657 (UMLS CUI [4,3])
Substance Dependence
Item
no history of drug or alcohol dependence in the past 2 years
boolean
C0038580 (UMLS CUI [1])
Substance Use Disorders Evidence
Item
no evidence of drug or alcohol abuse in the past year, as determined by the dsm-iv criteria.
boolean
C0038586 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
Narcolepsy
Item
no diagnosis of narcolepsy as determined by dsm-iv criteria
boolean
C0027404 (UMLS CUI [1])
Contact person Approved
Item
must have an approved contact person for the duration of the study
boolean
C0337611 (UMLS CUI [1,1])
C0205540 (UMLS CUI [1,2])
Selective Serotonin Reuptake Inhibitors Depressive Symptoms
Item
may be on a stable dose of ssri for depressive symptoms
boolean
C0360105 (UMLS CUI [1,1])
C0086132 (UMLS CUI [1,2])
Aggressive behavior
Item
no history of aggression
boolean
C0001807 (UMLS CUI [1])
Uncontrolled hypertension
Item
no uncontrolled hypertension, as defined below (subjects cannot have any of the following):
boolean
C1868885 (UMLS CUI [1])
Hypertensive disease New diagnosis
Item
1. a new diagnosis of hypertension, or
boolean
C0020538 (UMLS CUI [1,1])
C2585997 (UMLS CUI [1,2])
Antihypertensive Agents Change
Item
2. a change in antihypertensive medications in the past 30 days, or
boolean
C0003364 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Hypertensive disease | Systolic Pressure | Diastolic blood pressure
Item
3. acute hypertension (systolic>160mmhg, diastolic>100mmhg)
boolean
C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Benzodiazepines Dose Stable
Item
maybe on a stable dose of a benzodiazepine
boolean
C0005064 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Methylphenidate | Amphetamines | Pemoline | zolpidem | Monoamine Oxidase Inhibitors | Anticoagulants | Tricarboxylic Acids | Barbiturates
Item
the following medications will not be allowed during the study- methylphenidate, amphetamines, pemoline, zolpidem, mao inhibitors, anticoagulant, tca's, or barbiturates.
boolean
C0025810 (UMLS CUI [1])
C0002667 (UMLS CUI [2])
C0030800 (UMLS CUI [3])
C0078839 (UMLS CUI [4])
C0026457 (UMLS CUI [5])
C0003280 (UMLS CUI [6])
C0040887 (UMLS CUI [7])
C0004745 (UMLS CUI [8])
Atypical antipsychotic Dose Stable
Item
be on a stable does of an atypical neuroleptic
boolean
C1276996 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Anticonvulsants Mood Stabilization
Item
may be on a stable does of an anticonvulsant for mood stabilization
boolean
C0003286 (UMLS CUI [1,1])
C0026516 (UMLS CUI [1,2])
C1293130 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Gender
Item
subjects cannot be female.
boolean
C0079399 (UMLS CUI [1])
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