ID

13692

Beschreibung

Treatment Resistant Depression (Pilot); ODM derived from: https://clinicaltrials.gov/show/NCT01179009

Link

https://clinicaltrials.gov/show/NCT01179009

Stichworte

Versionen (1)
  1. 28.02.16 28.02.16 -
Hochgeladen am

28. Februar 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Depressive Disorder, Treatment-Resistant NCT01179009

Englisch

Eligibility Depressive Disorder, Treatment-Resistant NCT01179009

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males and females aged 18-65 years;
Beschreibung

gender; age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. diagnostic and statistical manual (dsm) iv diagnosis of major depressive disorder, recurrent, severe;
Beschreibung

dsm iv; major depressive disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0220952
UMLS CUI [2]
C1269683
3. depression must be considered treatment refractory as defined by montgomery asberg depression rating scale (madrs) score of 22 or above which is consistent with other studies;
Beschreibung

depression therapy refractory

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C1846625
4. on a stable dose of permitted antidepressant medication or no medication pre-infusion;
Beschreibung

antidepressant agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0003289
5. not currently psychotic and no history of psychosis within the previous 12 months; psychosis reported in the distant past may not be exclusionary if brief, per pi's judgment;
Beschreibung

medical history Psychotic Disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0033975
6. no history of significant clinical or intolerable side effects or complications from clonidine;
Beschreibung

hypersensitivity clonidine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0009014
7. if a female of child-bearing potential: not pregnant or breast feeding and agrees to use birth control during the time of pre-dosing and infusions; and
Beschreibung

Contraception status

Datentyp

boolean

Alias
UMLS CUI [1]
C0420837
8. able to give informed consent.
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. confirmed bipolar disorder, schizophrenia, or schizoaffective disorder;
Beschreibung

bipolar disorder; schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0036341
2. current or recent substance abuse/dependence (or any lifetime recreational ketamine or pcp use);
Beschreibung

substance abuse disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C1537075
3. any severe axis ii personality disorder or schizophrenia spectrum disorder that, in the pi's judgment, could confound diagnosis or adherence to treatment;
Beschreibung

axis ii disorder; personality disorder; Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0741358
UMLS CUI [2]
C0031212
UMLS CUI [3]
C0036341
4. the presence of any abnormal laboratory findings or serious medical disorder or condition that may, in the judgment of the pi, confound the assessment of relevant biologic measures or diagnoses including: clinically significant organ system dysfunction; significant and uncontrolled endocrine disease, including diabetes mellitus; hypothyroidism; cardiovascular disease; coagulopathy; significant anemia; significant acute infection; glaucoma; dehydration; epilepsy; any diagnosed cardiac condition causing documented hemodynamic compromise or dysfunction of the sa or av node; any diagnosed respiratory condition causing documented or clinically recognized hypoxia (e.g., chronic obstructive or restrictive pulmonary disease); after evaluation, anyone determined to have a potentially compromised airway that could be difficult to intubate; fever; bmi less than 14.5; or any medical condition known to interfere with cognitive performance; medication-related exclusions include memantine, or any medication that could be considered contraindicated ketamine;
Beschreibung

Compliance behavior Limited Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
5. current treatment with any medication contraindicated with ketamine or clonidine;
Beschreibung

concomitant medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
6. lifetime illegal use of pcp or ketamine; no clinical use of ketamine for past 3 months
Beschreibung

Ketamine abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C3824685
7. meets dsm-iv criteria for mental retardation;
Beschreibung

dsm-iv mental retardation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220952
UMLS CUI [1,2]
C0025362
8. currently hospitalized;
Beschreibung

hospitalization

Datentyp

boolean

Alias
UMLS CUI [1]
C0019993
9. acutely suicidal or homicidal (i.e., in imminent danger with plan, urges and intent to harm oneself or others) including any prior serious attempts (e.g., those requiring hospitalization) at the pi's discretion;
Beschreibung

suicidal; homicidal

Datentyp

boolean

Alias
UMLS CUI [1]
C0438696
UMLS CUI [2]
C0745031
10. is pregnant or breast-feeding; unwilling to use birth control if female of child bearing potential
Beschreibung

pregnancy; lactating

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
11. unable to provide informed consent.
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
12. for participants in the neuroimaging subset: history of claustrophobia, serious head injuries, seizures disorder, developmental delays, pacemaker, metal implants, permanent metal piercings or anything else that would preclude having an mri.
Beschreibung

neuroimaging; mri; claustrophobia

Datentyp

boolean

Alias
UMLS CUI [1]
C0679575
UMLS CUI [2]
C0024485
UMLS CUI [3]
C0008909
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Ähnliche Modelle

Eligibility Depressive Disorder, Treatment-Resistant NCT01179009

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
gender; age
Item
1. males and females aged 18-65 years;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
dsm iv; major depressive disorder
Item
2. diagnostic and statistical manual (dsm) iv diagnosis of major depressive disorder, recurrent, severe;
boolean
C0220952 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
depression therapy refractory
Item
3. depression must be considered treatment refractory as defined by montgomery asberg depression rating scale (madrs) score of 22 or above which is consistent with other studies;
boolean
C0011581 (UMLS CUI [1,1])
C1846625 (UMLS CUI [1,2])
antidepressant agents
Item
4. on a stable dose of permitted antidepressant medication or no medication pre-infusion;
boolean
C0003289 (UMLS CUI [1])
medical history Psychotic Disorders
Item
5. not currently psychotic and no history of psychosis within the previous 12 months; psychosis reported in the distant past may not be exclusionary if brief, per pi's judgment;
boolean
C0262926 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])
hypersensitivity clonidine
Item
6. no history of significant clinical or intolerable side effects or complications from clonidine;
boolean
C0020517 (UMLS CUI [1,1])
C0009014 (UMLS CUI [1,2])
Contraception status
Item
7. if a female of child-bearing potential: not pregnant or breast feeding and agrees to use birth control during the time of pre-dosing and infusions; and
boolean
C0420837 (UMLS CUI [1])
informed consent
Item
8. able to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
bipolar disorder; schizophrenia
Item
1. confirmed bipolar disorder, schizophrenia, or schizoaffective disorder;
boolean
C0005586 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
substance abuse disorder
Item
2. current or recent substance abuse/dependence (or any lifetime recreational ketamine or pcp use);
boolean
C1537075 (UMLS CUI [1])
axis ii disorder; personality disorder; Schizophrenia
Item
3. any severe axis ii personality disorder or schizophrenia spectrum disorder that, in the pi's judgment, could confound diagnosis or adherence to treatment;
boolean
C0741358 (UMLS CUI [1])
C0031212 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
Compliance behavior Limited Comorbidity
Item
4. the presence of any abnormal laboratory findings or serious medical disorder or condition that may, in the judgment of the pi, confound the assessment of relevant biologic measures or diagnoses including: clinically significant organ system dysfunction; significant and uncontrolled endocrine disease, including diabetes mellitus; hypothyroidism; cardiovascular disease; coagulopathy; significant anemia; significant acute infection; glaucoma; dehydration; epilepsy; any diagnosed cardiac condition causing documented hemodynamic compromise or dysfunction of the sa or av node; any diagnosed respiratory condition causing documented or clinically recognized hypoxia (e.g., chronic obstructive or restrictive pulmonary disease); after evaluation, anyone determined to have a potentially compromised airway that could be difficult to intubate; fever; bmi less than 14.5; or any medical condition known to interfere with cognitive performance; medication-related exclusions include memantine, or any medication that could be considered contraindicated ketamine;
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
concomitant medication
Item
5. current treatment with any medication contraindicated with ketamine or clonidine;
boolean
C2347852 (UMLS CUI [1])
Ketamine abuse
Item
6. lifetime illegal use of pcp or ketamine; no clinical use of ketamine for past 3 months
boolean
C3824685 (UMLS CUI [1])
dsm-iv mental retardation
Item
7. meets dsm-iv criteria for mental retardation;
boolean
C0220952 (UMLS CUI [1,1])
C0025362 (UMLS CUI [1,2])
hospitalization
Item
8. currently hospitalized;
boolean
C0019993 (UMLS CUI [1])
suicidal; homicidal
Item
9. acutely suicidal or homicidal (i.e., in imminent danger with plan, urges and intent to harm oneself or others) including any prior serious attempts (e.g., those requiring hospitalization) at the pi's discretion;
boolean
C0438696 (UMLS CUI [1])
C0745031 (UMLS CUI [2])
pregnancy; lactating
Item
10. is pregnant or breast-feeding; unwilling to use birth control if female of child bearing potential
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
informed consent
Item
11. unable to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
neuroimaging; mri; claustrophobia
Item
12. for participants in the neuroimaging subset: history of claustrophobia, serious head injuries, seizures disorder, developmental delays, pacemaker, metal implants, permanent metal piercings or anything else that would preclude having an mri.
boolean
C0679575 (UMLS CUI [1])
C0024485 (UMLS CUI [2])
C0008909 (UMLS CUI [3])
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