ID

15068

Beskrivning

Effect of Nicotine on Brain Reward Pathways; ODM derived from: https://clinicaltrials.gov/show/NCT02346539

Länk

https://clinicaltrials.gov/show/NCT02346539

Nyckelord

Versioner (1)
  1. 2016-05-13 2016-05-13 -
Uppladdad den

13 maj 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Depressive Disorder NCT02346539

Engelsk

Eligibility Depressive Disorder NCT02346539

1 Formulär  
Criteria
Beskrivning

Criteria

1. provide written informed consent;
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. both genders and all ethnic origins, age between 18 and 45;
Beskrivning

Age | Ethnic group All

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0015031
UMLS CUI [2,2]
C0444868
3. meet dsm-iv diagnostic criteria for mdd (diagnosed with the use of the scid);
Beskrivning

Major Depressive Disorder | DSM-IV criteria for major depressive diagnosis documented SCID interview

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2,1]
C2199206
UMLS CUI [2,2]
C1537054
4. a baseline ham-d score of 16 or greater;
Beskrivning

Hamilton rating scale for depression Score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0451203
UMLS CUI [1,2]
C0449820
5. absence of pregnancy;
Beskrivning

Pregnancy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
6. absence of any psychotropic medication for at least 2 weeks:
Beskrivning

Psychotropic Drugs Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0332197
1. 6 weeks for fluoxetine
Beskrivning

Fluoxetine

Datatyp

boolean

Alias
UMLS CUI [1]
C0016365
2. 6 months for neuroleptics
Beskrivning

Antipsychotic Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0040615
3. 2 weeks for benzodiazepines
Beskrivning

Benzodiazepines

Datatyp

boolean

Alias
UMLS CUI [1]
C0005064
4. 2 weeks for any other antidepressants
Beskrivning

Antidepressive Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0003289
inclusion criteria for healthy controls
Beskrivning

Inclusion Healthy Control

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C2986479
1. absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse); as assessed by subject history and a structured clinical interview (scid);
Beskrivning

Disease Absent | Nervous system disorder Absent | Mental disorders Absent | Substance Use Disorders Absent | SCID interview

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0038586
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C1537054
2. provide written informed consent;
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
3. both genders and all ethnic origins, age between 18 and 45;
Beskrivning

Age | Ethnic group All

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0015031
UMLS CUI [2,2]
C0444868
4. absence of any medications for at least 3 weeks;
Beskrivning

Pharmaceutical Preparations Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332197
5. absence of pregnancy.
Beskrivning

Pregnancy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects with suicidal ideation where outpatient treatment is determined unsafe. these patients will be immediately referred to a licensed psychologist or psychiatrist to determine the appropriate clinical treatment;
Beskrivning

Feeling suicidal | Ambulatory care services Unsafe condition

Datatyp

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2,1]
C0002423
UMLS CUI [2,2]
C4036038
2. serious or unstable medical illness
Beskrivning

Severe disorder | Disease Unstable status

Datatyp

boolean

Alias
UMLS CUI [1]
C1836348
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
3. lifetime history of seizure disorder;
Beskrivning

Seizures Lifelong occurrence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C3280928
4. lifetime history or current diagnosis of any of the following dsm-iv psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, adhd, patients with mood congruent or mood incongruent psychotic features; simple phobia, social anxiety disorder and generalized anxiety disorders will be allowed only if secondary to mdd;
Beskrivning

Lifelong occurrence Mental disorders DSM-IV | Chronic organic mental disorder | Schizophrenia | Schizoaffective Disorder | Delusional disorder | Psychotic Disorders | Attention deficit hyperactivity disorder | Depression psychotic feature | Phobia, Specific | Phobia, Social | Generalized Anxiety Disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3280928
UMLS CUI [1,2]
C0004936
UMLS CUI [1,3]
C0220952
UMLS CUI [2]
C0683405
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0036337
UMLS CUI [5]
C0011251
UMLS CUI [6]
C0033975
UMLS CUI [7]
C1263846
UMLS CUI [8]
C0743076
UMLS CUI [9]
C0236801
UMLS CUI [10]
C0031572
UMLS CUI [11]
C0270549
5. patients with a lifetime history of electroconvulsive therapy (ect);
Beskrivning

Lifelong occurrence Electroconvulsive Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3280928
UMLS CUI [1,2]
C0013806
6. failure to meet standard mri safety requirements;
Beskrivning

Magnetic Resonance Imaging Safety Requirement failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0036043
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0231175
7. may not have used any nicotine product in the past year; must report fewer than 20 lifetime uses of nicotine
Beskrivning

Use of Nicotine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0028040
8. must have an expired carbon monoxide level of less than or equal to 10 ppm.
Beskrivning

Blood carbon monoxide measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0428252
9. use of anticholinergic drugs in the past week
Beskrivning

Use of Anticholinergic Agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0242896
10. any past or present history of cardiac problems including known arrhythmias, acute coronary syndrome, or ischemic heart disease
Beskrivning

H/O: heart disorder | Cardiac Arrhythmia | Acute Coronary Syndrome | Myocardial Ischemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0559157
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0948089
UMLS CUI [4]
C0151744
11. uncontrolled hypertension
Beskrivning

Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
12. history of substance abuse in the past 6 months (other than caffeine), self-reported use of marijuana in past month, or history of treatment with methadone
Beskrivning

History of substance abuse | Caffeine | Marihuana | Methadone treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C1299544
UMLS CUI [2]
C0006644
UMLS CUI [3]
C0024808
UMLS CUI [4]
C0746569
13. heavy caffeine users (consume greater than 500 mg on a regular or daily basis)
Beskrivning

Caffeine user | Caffeine consumption High

Datatyp

boolean

Alias
UMLS CUI [1]
C3532939
UMLS CUI [2,1]
C0948365
UMLS CUI [2,2]
C0205250
Tillbaka till toppen

Similar models

Eligibility Depressive Disorder NCT02346539

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Informed Consent
Item
1. provide written informed consent;
boolean
C0021430 (UMLS CUI [1])
Age | Ethnic group All
Item
2. both genders and all ethnic origins, age between 18 and 45;
boolean
C0001779 (UMLS CUI [1])
C0015031 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
Major Depressive Disorder | DSM-IV criteria for major depressive diagnosis documented SCID interview
Item
3. meet dsm-iv diagnostic criteria for mdd (diagnosed with the use of the scid);
boolean
C1269683 (UMLS CUI [1])
C2199206 (UMLS CUI [2,1])
C1537054 (UMLS CUI [2,2])
Hamilton rating scale for depression Score
Item
4. a baseline ham-d score of 16 or greater;
boolean
C0451203 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Pregnancy Absent
Item
5. absence of pregnancy;
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Psychotropic Drugs Absent
Item
6. absence of any psychotropic medication for at least 2 weeks:
boolean
C0033978 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Fluoxetine
Item
1. 6 weeks for fluoxetine
boolean
C0016365 (UMLS CUI [1])
Antipsychotic Agents
Item
2. 6 months for neuroleptics
boolean
C0040615 (UMLS CUI [1])
Benzodiazepines
Item
3. 2 weeks for benzodiazepines
boolean
C0005064 (UMLS CUI [1])
Antidepressive Agents
Item
4. 2 weeks for any other antidepressants
boolean
C0003289 (UMLS CUI [1])
Inclusion Healthy Control
Item
inclusion criteria for healthy controls
boolean
C1512693 (UMLS CUI [1,1])
C2986479 (UMLS CUI [1,2])
Disease Absent | Nervous system disorder Absent | Mental disorders Absent | Substance Use Disorders Absent | SCID interview
Item
1. absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse); as assessed by subject history and a structured clinical interview (scid);
boolean
C0012634 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0004936 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0038586 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1537054 (UMLS CUI [5])
Informed Consent
Item
2. provide written informed consent;
boolean
C0021430 (UMLS CUI [1])
Age | Ethnic group All
Item
3. both genders and all ethnic origins, age between 18 and 45;
boolean
C0001779 (UMLS CUI [1])
C0015031 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
Pharmaceutical Preparations Absent
Item
4. absence of any medications for at least 3 weeks;
boolean
C0013227 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Pregnancy Absent
Item
5. absence of pregnancy.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Feeling suicidal | Ambulatory care services Unsafe condition
Item
1. subjects with suicidal ideation where outpatient treatment is determined unsafe. these patients will be immediately referred to a licensed psychologist or psychiatrist to determine the appropriate clinical treatment;
boolean
C0424000 (UMLS CUI [1])
C0002423 (UMLS CUI [2,1])
C4036038 (UMLS CUI [2,2])
Severe disorder | Disease Unstable status
Item
2. serious or unstable medical illness
boolean
C1836348 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Seizures Lifelong occurrence
Item
3. lifetime history of seizure disorder;
boolean
C0036572 (UMLS CUI [1,1])
C3280928 (UMLS CUI [1,2])
Lifelong occurrence Mental disorders DSM-IV | Chronic organic mental disorder | Schizophrenia | Schizoaffective Disorder | Delusional disorder | Psychotic Disorders | Attention deficit hyperactivity disorder | Depression psychotic feature | Phobia, Specific | Phobia, Social | Generalized Anxiety Disorder
Item
4. lifetime history or current diagnosis of any of the following dsm-iv psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, adhd, patients with mood congruent or mood incongruent psychotic features; simple phobia, social anxiety disorder and generalized anxiety disorders will be allowed only if secondary to mdd;
boolean
C3280928 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0220952 (UMLS CUI [1,3])
C0683405 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0011251 (UMLS CUI [5])
C0033975 (UMLS CUI [6])
C1263846 (UMLS CUI [7])
C0743076 (UMLS CUI [8])
C0236801 (UMLS CUI [9])
C0031572 (UMLS CUI [10])
C0270549 (UMLS CUI [11])
Lifelong occurrence Electroconvulsive Therapy
Item
5. patients with a lifetime history of electroconvulsive therapy (ect);
boolean
C3280928 (UMLS CUI [1,1])
C0013806 (UMLS CUI [1,2])
Magnetic Resonance Imaging Safety Requirement failed
Item
6. failure to meet standard mri safety requirements;
boolean
C0024485 (UMLS CUI [1,1])
C0036043 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
Use of Nicotine
Item
7. may not have used any nicotine product in the past year; must report fewer than 20 lifetime uses of nicotine
boolean
C1524063 (UMLS CUI [1,1])
C0028040 (UMLS CUI [1,2])
Blood carbon monoxide measurement
Item
8. must have an expired carbon monoxide level of less than or equal to 10 ppm.
boolean
C0428252 (UMLS CUI [1])
Use of Anticholinergic Agents
Item
9. use of anticholinergic drugs in the past week
boolean
C1524063 (UMLS CUI [1,1])
C0242896 (UMLS CUI [1,2])
H/O: heart disorder | Cardiac Arrhythmia | Acute Coronary Syndrome | Myocardial Ischemia
Item
10. any past or present history of cardiac problems including known arrhythmias, acute coronary syndrome, or ischemic heart disease
boolean
C0559157 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0948089 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
Uncontrolled hypertension
Item
11. uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
History of substance abuse | Caffeine | Marihuana | Methadone treatment
Item
12. history of substance abuse in the past 6 months (other than caffeine), self-reported use of marijuana in past month, or history of treatment with methadone
boolean
C1299544 (UMLS CUI [1])
C0006644 (UMLS CUI [2])
C0024808 (UMLS CUI [3])
C0746569 (UMLS CUI [4])
Caffeine user | Caffeine consumption High
Item
13. heavy caffeine users (consume greater than 500 mg on a regular or daily basis)
boolean
C3532939 (UMLS CUI [1])
C0948365 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
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