ID

15056

Beschreibung

tDCS in Parkinson's Disease With Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02315781

Link

https://clinicaltrials.gov/show/NCT02315781

Stichworte

Versionen (1)
  1. 13.05.16 13.05.16 -
Hochgeladen am

13. Mai 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Depression NCT02315781

Englisch

Eligibility Depression NCT02315781

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02315781
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. are outpatients,
Beschreibung

Outpatients

Datentyp

boolean

Alias
UMLS CUI [1]
C0029921
2. are voluntary and competent to consent to treatment,
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
3. have a mini-international neuropsychiatric interview (mini) confirmed diagnosis of major depressive disorder (mdd),
Beschreibung

Major Depressive Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C1269683
4. have a diagnosis of pd according to the uk pd brain bank criteria,
Beschreibung

Parkinson Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0030567
5. are 19 years of age or more,
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
6. have a score > 13 on the beck depression inventory-ii (bdi-ii),
Beschreibung

Beck depression inventory score

Datentyp

boolean

Alias
UMLS CUI [1]
C2960571
7. still have depressive symptoms after 6 weeks or more of antidepressant (ssri) medication treatment (and on a stabilized dose of at least 4 weeks),
Beschreibung

Depressive Symptoms | Therapeutic procedure Antidepressive Agents Selective Serotonin Reuptake Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C0086132
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0003289
UMLS CUI [2,3]
C0360105
8. are able to adhere to the treatment schedule,
Beschreibung

Complies with treatment schedule

Datentyp

boolean

Alias
UMLS CUI [1]
C1822026
9. are proficient in written and verbal english.
Beschreibung

Able to speak English Language | Able to write English Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. have a history of substance dependence or abuse within the last 6 months,
Beschreibung

Substance Dependence | Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0038586
2. have a concomitant significant unstable medical illness,
Beschreibung

concomitant disease Unstable status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243087
UMLS CUI [1,2]
C0443343
3. have active suicidal intent,
Beschreibung

Suicidal intent

Datentyp

boolean

Alias
UMLS CUI [1]
C0582496
4. have any history of seizure or medication-resistant epilepsy in the family,
Beschreibung

Family history of seizure | FH: Epilepsy | Drug Resistant Epilepsy

Datentyp

boolean

Alias
UMLS CUI [1]
C3267207
UMLS CUI [2]
C0455392
UMLS CUI [3]
C1096063
5. have a lifetime mini-international neuropsychiatric interview (mini) diagnosis of bipolar i or ii disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
Beschreibung

Bipolar I disorder | Bipolar II disorder | Schizophrenia | Schizoaffective Disorder | Schizophreniform Disorders | Delusional disorder | Psychotic symptom

Datentyp

boolean

Alias
UMLS CUI [1]
C0853193
UMLS CUI [2]
C0236788
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0036337
UMLS CUI [5]
C0036358
UMLS CUI [6]
C0011251
UMLS CUI [7]
C0871189
6. have a mini diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, assessed by a study investigator to be primary and causing greater impairment than mdd,
Beschreibung

Obsessive-Compulsive Disorder | Post-Traumatic Stress Disorder | Anxiety Disorders | Generalized Anxiety Disorder | Phobia, Social | Panic Disorder | Dysthymic Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0028768
UMLS CUI [2]
C0038436
UMLS CUI [3]
C0003469
UMLS CUI [4]
C0270549
UMLS CUI [5]
C0031572
UMLS CUI [6]
C0030319
UMLS CUI [7]
C0013415
7. have failed a course of ect in the current episode or previous episode,
Beschreibung

Electroconvulsive Therapy failed | Episode of Mental Depression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013806
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0011570
8. have received tdcs or other neurostimulation therapy for any previous indication due to the potential compromise of expectancy effects,
Beschreibung

Transcranial Direct Current Stimulation | Neurostimulation/modulation

Datentyp

boolean

Alias
UMLS CUI [1]
C3850024
UMLS CUI [2]
C0394674
9. have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ect, cerebral aneurysm, huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes, or developmental disorder,
Beschreibung

nervous system disorder | Seizures | Increased intracranial pressure disorders | Mass lesion of brain | Electroconvulsive Therapy | Cerebral Aneurysm | Huntington Disease | Multiple Sclerosis | Craniocerebral Trauma Unconscious State | Developmental Disabilities

Datentyp

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0036572
UMLS CUI [3]
C1328276
UMLS CUI [4]
C0742078
UMLS CUI [5]
C0013806
UMLS CUI [6]
C0917996
UMLS CUI [7]
C0020179
UMLS CUI [8]
C0026769
UMLS CUI [9,1]
C0018674
UMLS CUI [9,2]
C0041657
UMLS CUI [10]
C0008073
10. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed,
Beschreibung

Implants Intracranial | Aneurysm clip | Shunt Device | Stimulator | Cochlear Implants | Electrodes, Implanted | Metal device

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0524466
UMLS CUI [2]
C0179977
UMLS CUI [3]
C0542331
UMLS CUI [4]
C0175727
UMLS CUI [5]
C0009199
UMLS CUI [6]
C0013814
UMLS CUI [7]
C0336536
11. are taking a non-ssri antidepressant medication,
Beschreibung

Selective Serotonin Reuptake Inhibitors Antidepressive Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0360105
UMLS CUI [1,2]
C0003289
12. are pregnant (women of childbearing age only).
Beschreibung

Pregnancy | Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
exclusion criteria for pet:
Beschreibung

Exclusion Criteria Positron-Emission Tomography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0032743
1. unable to tolerate staying off anti-parkinsonian medication for 12-18 hours pre-pet scan,
Beschreibung

Unable stop medication Antiparkinson Agents | Positron-Emission Tomography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0850893
UMLS CUI [1,3]
C0003405
UMLS CUI [2]
C0032743
2. have a history of radiation therapy treatment or other high amounts of radiation.
Beschreibung

Therapeutic radiology procedure | Radiation

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0851346
exclusion criteria for mri:
Beschreibung

Exclusion Criteria Magnetic Resonance Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0024485
artificial heart valve;
Beschreibung

artificial heart valve

Datentyp

boolean

Alias
UMLS CUI [1]
C1399223
brain aneurysm clip;
Beschreibung

Brain Aneurysm Clip

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0751003
UMLS CUI [1,2]
C0175722
electrical stimulator for nerves or bones;
Beschreibung

Stimulators, Electrical | Nerve | Skeletal bone

Datentyp

boolean

Alias
UMLS CUI [1]
C0180687
UMLS CUI [2]
C0027740
UMLS CUI [3]
C0262950
ear or eye implant;
Beschreibung

Implant ear | Ophthalmological implant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0521421
UMLS CUI [2]
C0581278
implanted drug infusion pump;
Beschreibung

Drug infusion pumps Implants

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3825405
UMLS CUI [1,2]
C0021102
coil, catheter, or filter in any blood vessel;
Beschreibung

Blood Vessel | Coil Device Component | Catheter device | Filter - medical device

Datentyp

boolean

Alias
UMLS CUI [1]
C0005847
UMLS CUI [2]
C1705946
UMLS CUI [3]
C0085590
UMLS CUI [4]
C1875155
orthopedic hardware (artificial joint, plate, screws);
Beschreibung

ORTHOPEDIC DEVICES AND HARDWARE | artificial joint | Device Plate | Screw

Datentyp

boolean

Alias
UMLS CUI [1]
C0336577
UMLS CUI [2]
C0481488
UMLS CUI [3]
C1139930
UMLS CUI [4]
C0301559
other metallic prostheses;
Beschreibung

Prosthesis Metallic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0175649
UMLS CUI [1,2]
C2986473
shrapnel, bullets, or other metal fragments;
Beschreibung

Shrapnel | Bullet | Fragment of Metal

Datentyp

boolean

Alias
UMLS CUI [1]
C0522670
UMLS CUI [2]
C0336699
UMLS CUI [3,1]
C0332255
UMLS CUI [3,2]
C0025552
surgery or tattoos (including tattooed eyeliner) in the last six weeks.
Beschreibung

Operative Surgical Procedures | Tattoo

Datentyp

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C1366940
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Ähnliche Modelle

Eligibility Depression NCT02315781

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02315781
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients
Item
1. are outpatients,
boolean
C0029921 (UMLS CUI [1])
Informed Consent
Item
2. are voluntary and competent to consent to treatment,
boolean
C0021430 (UMLS CUI [1])
Major Depressive Disorder
Item
3. have a mini-international neuropsychiatric interview (mini) confirmed diagnosis of major depressive disorder (mdd),
boolean
C1269683 (UMLS CUI [1])
Parkinson Disease
Item
4. have a diagnosis of pd according to the uk pd brain bank criteria,
boolean
C0030567 (UMLS CUI [1])
Age
Item
5. are 19 years of age or more,
boolean
C0001779 (UMLS CUI [1])
Beck depression inventory score
Item
6. have a score > 13 on the beck depression inventory-ii (bdi-ii),
boolean
C2960571 (UMLS CUI [1])
Depressive Symptoms | Therapeutic procedure Antidepressive Agents Selective Serotonin Reuptake Inhibitors
Item
7. still have depressive symptoms after 6 weeks or more of antidepressant (ssri) medication treatment (and on a stabilized dose of at least 4 weeks),
boolean
C0086132 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0003289 (UMLS CUI [2,2])
C0360105 (UMLS CUI [2,3])
Complies with treatment schedule
Item
8. are able to adhere to the treatment schedule,
boolean
C1822026 (UMLS CUI [1])
Able to speak English Language | Able to write English Language
Item
9. are proficient in written and verbal english.
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Substance Dependence | Substance Use Disorders
Item
1. have a history of substance dependence or abuse within the last 6 months,
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
concomitant disease Unstable status
Item
2. have a concomitant significant unstable medical illness,
boolean
C0243087 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Suicidal intent
Item
3. have active suicidal intent,
boolean
C0582496 (UMLS CUI [1])
Family history of seizure | FH: Epilepsy | Drug Resistant Epilepsy
Item
4. have any history of seizure or medication-resistant epilepsy in the family,
boolean
C3267207 (UMLS CUI [1])
C0455392 (UMLS CUI [2])
C1096063 (UMLS CUI [3])
Bipolar I disorder | Bipolar II disorder | Schizophrenia | Schizoaffective Disorder | Schizophreniform Disorders | Delusional disorder | Psychotic symptom
Item
5. have a lifetime mini-international neuropsychiatric interview (mini) diagnosis of bipolar i or ii disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
boolean
C0853193 (UMLS CUI [1])
C0236788 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0036358 (UMLS CUI [5])
C0011251 (UMLS CUI [6])
C0871189 (UMLS CUI [7])
Obsessive-Compulsive Disorder | Post-Traumatic Stress Disorder | Anxiety Disorders | Generalized Anxiety Disorder | Phobia, Social | Panic Disorder | Dysthymic Disorder
Item
6. have a mini diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, assessed by a study investigator to be primary and causing greater impairment than mdd,
boolean
C0028768 (UMLS CUI [1])
C0038436 (UMLS CUI [2])
C0003469 (UMLS CUI [3])
C0270549 (UMLS CUI [4])
C0031572 (UMLS CUI [5])
C0030319 (UMLS CUI [6])
C0013415 (UMLS CUI [7])
Electroconvulsive Therapy failed | Episode of Mental Depression
Item
7. have failed a course of ect in the current episode or previous episode,
boolean
C0013806 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0332189 (UMLS CUI [2,1])
C0011570 (UMLS CUI [2,2])
Transcranial Direct Current Stimulation | Neurostimulation/modulation
Item
8. have received tdcs or other neurostimulation therapy for any previous indication due to the potential compromise of expectancy effects,
boolean
C3850024 (UMLS CUI [1])
C0394674 (UMLS CUI [2])
nervous system disorder | Seizures | Increased intracranial pressure disorders | Mass lesion of brain | Electroconvulsive Therapy | Cerebral Aneurysm | Huntington Disease | Multiple Sclerosis | Craniocerebral Trauma Unconscious State | Developmental Disabilities
Item
9. have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ect, cerebral aneurysm, huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes, or developmental disorder,
boolean
C0027765 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
C1328276 (UMLS CUI [3])
C0742078 (UMLS CUI [4])
C0013806 (UMLS CUI [5])
C0917996 (UMLS CUI [6])
C0020179 (UMLS CUI [7])
C0026769 (UMLS CUI [8])
C0018674 (UMLS CUI [9,1])
C0041657 (UMLS CUI [9,2])
C0008073 (UMLS CUI [10])
Implants Intracranial | Aneurysm clip | Shunt Device | Stimulator | Cochlear Implants | Electrodes, Implanted | Metal device
Item
10. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed,
boolean
C0021102 (UMLS CUI [1,1])
C0524466 (UMLS CUI [1,2])
C0179977 (UMLS CUI [2])
C0542331 (UMLS CUI [3])
C0175727 (UMLS CUI [4])
C0009199 (UMLS CUI [5])
C0013814 (UMLS CUI [6])
C0336536 (UMLS CUI [7])
Selective Serotonin Reuptake Inhibitors Antidepressive Agents
Item
11. are taking a non-ssri antidepressant medication,
boolean
C0360105 (UMLS CUI [1,1])
C0003289 (UMLS CUI [1,2])
Pregnancy | Childbearing Potential
Item
12. are pregnant (women of childbearing age only).
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
Exclusion Criteria Positron-Emission Tomography
Item
exclusion criteria for pet:
boolean
C0680251 (UMLS CUI [1,1])
C0032743 (UMLS CUI [1,2])
Unable stop medication Antiparkinson Agents | Positron-Emission Tomography
Item
1. unable to tolerate staying off anti-parkinsonian medication for 12-18 hours pre-pet scan,
boolean
C1299582 (UMLS CUI [1,1])
C0850893 (UMLS CUI [1,2])
C0003405 (UMLS CUI [1,3])
C0032743 (UMLS CUI [2])
Therapeutic radiology procedure | Radiation
Item
2. have a history of radiation therapy treatment or other high amounts of radiation.
boolean
C1522449 (UMLS CUI [1])
C0851346 (UMLS CUI [2])
Exclusion Criteria Magnetic Resonance Imaging
Item
exclusion criteria for mri:
boolean
C0680251 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
artificial heart valve
Item
artificial heart valve;
boolean
C1399223 (UMLS CUI [1])
Brain Aneurysm Clip
Item
brain aneurysm clip;
boolean
C0751003 (UMLS CUI [1,1])
C0175722 (UMLS CUI [1,2])
Stimulators, Electrical | Nerve | Skeletal bone
Item
electrical stimulator for nerves or bones;
boolean
C0180687 (UMLS CUI [1])
C0027740 (UMLS CUI [2])
C0262950 (UMLS CUI [3])
Implant ear | Ophthalmological implant
Item
ear or eye implant;
boolean
C0021102 (UMLS CUI [1,1])
C0521421 (UMLS CUI [1,2])
C0581278 (UMLS CUI [2])
Drug infusion pumps Implants
Item
implanted drug infusion pump;
boolean
C3825405 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
Blood Vessel | Coil Device Component | Catheter device | Filter - medical device
Item
coil, catheter, or filter in any blood vessel;
boolean
C0005847 (UMLS CUI [1])
C1705946 (UMLS CUI [2])
C0085590 (UMLS CUI [3])
C1875155 (UMLS CUI [4])
ORTHOPEDIC DEVICES AND HARDWARE | artificial joint | Device Plate | Screw
Item
orthopedic hardware (artificial joint, plate, screws);
boolean
C0336577 (UMLS CUI [1])
C0481488 (UMLS CUI [2])
C1139930 (UMLS CUI [3])
C0301559 (UMLS CUI [4])
Prosthesis Metallic
Item
other metallic prostheses;
boolean
C0175649 (UMLS CUI [1,1])
C2986473 (UMLS CUI [1,2])
Shrapnel | Bullet | Fragment of Metal
Item
shrapnel, bullets, or other metal fragments;
boolean
C0522670 (UMLS CUI [1])
C0336699 (UMLS CUI [2])
C0332255 (UMLS CUI [3,1])
C0025552 (UMLS CUI [3,2])
Operative Surgical Procedures | Tattoo
Item
surgery or tattoos (including tattooed eyeliner) in the last six weeks.
boolean
C0543467 (UMLS CUI [1])
C1366940 (UMLS CUI [2])
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