ID

36344

Beschreibung

Ketamine in Adolescents With Treatment-Resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02078817

Link

https://clinicaltrials.gov/show/NCT02078817

Stichworte

Versionen (1)
  1. 05.05.19 05.05.19 -
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See clinicaltrials.gov

Hochgeladen am

5. Mai 2019

DOI

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Eligibility Major Depressive Disorder NCT02078817

Englisch

Eligibility Major Depressive Disorder NCT02078817

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female adolescents aged 12 to 18 years.
Beschreibung

Adolescent | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0205653
UMLS CUI [2]
C0001779
presence of recurrent major depression without psychotic features confirmed by the k-sads-pl (kaufman et al., 1997).
Beschreibung

DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Recurrent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0743081
UMLS CUI [1,2]
C2945760
current depression severity measured by the children's depression rating scale (cdrs) (poznanski, 1985) raw score greater than or equal to 36 at screening and the day ketamine is due to be received for the first time.
Beschreibung

Depressive disorder Depression in children Rating scale | Ketamine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C3826462
UMLS CUI [1,3]
C0681889
UMLS CUI [2]
C0022614
current depressive episode resistant to treatment, defined as failure to achieve remission (elimination of symptoms and restoration of pre-morbid psychosocial functioning) from at least 2 antidepressant trials of different pharmacological classes. systematic evaluation of previous antidepressant trials will be assessed by using the antidepressant treatment history form (sackeim, 2001).
Beschreibung

Depressive episode Resistant to Treatment | Remission failed | Antidepressant therapy Quantity | Class pharmacological different

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0332325
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0544452
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C1096649
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0456387
UMLS CUI [4,2]
C0205464
UMLS CUI [4,3]
C1705242
if present, current antidepressant medication treatment must be dose stable for at least 2 months prior to beginning the study. (patients will continue with current antidepressant treatment throughout the study. based on our experience in current research at the va medical center using serial ketamine for adult trd, patients have shown positive results while continuing their current antidepressant treatment.)
Beschreibung

Antidepressant therapy Dose Stable | Ketamine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0022614
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to speak english
Beschreibung

Lacking Able to speak English Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
inability or unwillingness to provide written informed consent
Beschreibung

Informed Consent Unable | Informed Consent Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
a history of mental retardation or any pervasive developmental disorder
Beschreibung

Mental Retardation | Pervasive Development Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0025362
UMLS CUI [2]
C0524528
current or lifetime diagnosis of schizophrenia, schizoaffective disorder, or psychosis nos.
Beschreibung

Schizophrenia | Schizoaffective Disorder | Psychotic Disorder | Schizophrenia Lifetime | Schizoaffective Disorder Lifetime | Psychotic Disorder Lifetime

Datentyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
UMLS CUI [3]
C0033975
UMLS CUI [4,1]
C0036341
UMLS CUI [4,2]
C4071830
UMLS CUI [5,1]
C0036337
UMLS CUI [5,2]
C4071830
UMLS CUI [6,1]
C0033975
UMLS CUI [6,2]
C4071830
family history with a first degree relative with schizophrenia, schizoaffective disorder, or psychosis nos.
Beschreibung

First Degree Relative Schizophrenia | First Degree Relative Schizoaffective Disorder | First Degree Relative Psychotic Disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1517194
UMLS CUI [1,2]
C0036341
UMLS CUI [2,1]
C1517194
UMLS CUI [2,2]
C0036337
UMLS CUI [3,1]
C1517194
UMLS CUI [3,2]
C0033975
diagnosis of seizures or other neurological disorders.
Beschreibung

Seizures | Nervous system disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0027765
comorbid diagnosis of substance abuse or dependence, current or past.
Beschreibung

Comorbidity | Substance Use Disorders | Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0038580
clinically unstable medical illness.
Beschreibung

Illness Unstable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
current use of the following medications: any barbiturates, any narcotics, any non-benzodiazepine hypnotics at doses higher than zolpidem 10 mg qhs or equivalent for insomnia.
Beschreibung

Barbiturates | Narcotics | Hypnotics High dose Sleeplessness | Exception Benzodiazepines | Zolpidem Dose

Datentyp

boolean

Alias
UMLS CUI [1]
C0004745
UMLS CUI [2]
C0027415
UMLS CUI [3,1]
C0020591
UMLS CUI [3,2]
C0444956
UMLS CUI [3,3]
C0917801
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0005064
UMLS CUI [5,1]
C0078839
UMLS CUI [5,2]
C0178602
for women: pregnancy (confirmed by baseline lab test).
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
the presence of any mri contra-indications such as mri-incompatible metals in the body or claustrophobia.
Beschreibung

Medical contraindication MRI | Metals Body | Claustrophobia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C0025552
UMLS CUI [2,2]
C1318419
UMLS CUI [3]
C0008909
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Major Depressive Disorder NCT02078817

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adolescent | Age
Item
male and female adolescents aged 12 to 18 years.
boolean
C0205653 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Recurrent
Item
presence of recurrent major depression without psychotic features confirmed by the k-sads-pl (kaufman et al., 1997).
boolean
C0743081 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
Depressive disorder Depression in children Rating scale | Ketamine
Item
current depression severity measured by the children's depression rating scale (cdrs) (poznanski, 1985) raw score greater than or equal to 36 at screening and the day ketamine is due to be received for the first time.
boolean
C0011581 (UMLS CUI [1,1])
C3826462 (UMLS CUI [1,2])
C0681889 (UMLS CUI [1,3])
C0022614 (UMLS CUI [2])
Depressive episode Resistant to Treatment | Remission failed | Antidepressant therapy Quantity | Class pharmacological different
Item
current depressive episode resistant to treatment, defined as failure to achieve remission (elimination of symptoms and restoration of pre-morbid psychosocial functioning) from at least 2 antidepressant trials of different pharmacological classes. systematic evaluation of previous antidepressant trials will be assessed by using the antidepressant treatment history form (sackeim, 2001).
boolean
C0349217 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0544452 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C1096649 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0456387 (UMLS CUI [4,1])
C0205464 (UMLS CUI [4,2])
C1705242 (UMLS CUI [4,3])
Antidepressant therapy Dose Stable | Ketamine
Item
if present, current antidepressant medication treatment must be dose stable for at least 2 months prior to beginning the study. (patients will continue with current antidepressant treatment throughout the study. based on our experience in current research at the va medical center using serial ketamine for adult trd, patients have shown positive results while continuing their current antidepressant treatment.)
boolean
C1096649 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0022614 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Lacking Able to speak English Language
Item
inability to speak english
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
Informed Consent Unable | Informed Consent Unwilling
Item
inability or unwillingness to provide written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Mental Retardation | Pervasive Development Disorder
Item
a history of mental retardation or any pervasive developmental disorder
boolean
C0025362 (UMLS CUI [1])
C0524528 (UMLS CUI [2])
Schizophrenia | Schizoaffective Disorder | Psychotic Disorder | Schizophrenia Lifetime | Schizoaffective Disorder Lifetime | Psychotic Disorder Lifetime
Item
current or lifetime diagnosis of schizophrenia, schizoaffective disorder, or psychosis nos.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0036341 (UMLS CUI [4,1])
C4071830 (UMLS CUI [4,2])
C0036337 (UMLS CUI [5,1])
C4071830 (UMLS CUI [5,2])
C0033975 (UMLS CUI [6,1])
C4071830 (UMLS CUI [6,2])
First Degree Relative Schizophrenia | First Degree Relative Schizoaffective Disorder | First Degree Relative Psychotic Disorders
Item
family history with a first degree relative with schizophrenia, schizoaffective disorder, or psychosis nos.
boolean
C1517194 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C1517194 (UMLS CUI [2,1])
C0036337 (UMLS CUI [2,2])
C1517194 (UMLS CUI [3,1])
C0033975 (UMLS CUI [3,2])
Seizures | Nervous system disorder
Item
diagnosis of seizures or other neurological disorders.
boolean
C0036572 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
Comorbidity | Substance Use Disorders | Substance Dependence
Item
comorbid diagnosis of substance abuse or dependence, current or past.
boolean
C0009488 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0038580 (UMLS CUI [3])
Illness Unstable
Item
clinically unstable medical illness.
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Barbiturates | Narcotics | Hypnotics High dose Sleeplessness | Exception Benzodiazepines | Zolpidem Dose
Item
current use of the following medications: any barbiturates, any narcotics, any non-benzodiazepine hypnotics at doses higher than zolpidem 10 mg qhs or equivalent for insomnia.
boolean
C0004745 (UMLS CUI [1])
C0027415 (UMLS CUI [2])
C0020591 (UMLS CUI [3,1])
C0444956 (UMLS CUI [3,2])
C0917801 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0005064 (UMLS CUI [4,2])
C0078839 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
Pregnancy
Item
for women: pregnancy (confirmed by baseline lab test).
boolean
C0032961 (UMLS CUI [1])
Medical contraindication MRI | Metals Body | Claustrophobia
Item
the presence of any mri contra-indications such as mri-incompatible metals in the body or claustrophobia.
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0025552 (UMLS CUI [2,1])
C1318419 (UMLS CUI [2,2])
C0008909 (UMLS CUI [3])
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