ID

19365

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 22, 2016

DOI

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License

Creative Commons BY 4.0
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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

Brain damage Neurological | Cerebrovascular accident | Neoplasms | Trauma | Unconscious State

Data type

boolean

Alias
UMLS CUI [1,1]
C0270611
UMLS CUI [1,2]
C0205494
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0027651
UMLS CUI [4]
C3714660
UMLS CUI [5]
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])
Brain damage Neurological | Cerebrovascular accident | Neoplasms | Trauma | 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
C0270611 (UMLS CUI [1,1])
C0205494 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2])
C0027651 (UMLS CUI [3])
C3714660 (UMLS CUI [4])
C0041657 (UMLS CUI [5])
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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