ID

15986

Beschrijving

Efficacy of Repeated Ketamine Infusions for Treatment-resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02360280

Link

https://clinicaltrials.gov/show/NCT02360280

Trefwoorden

Versies (2)
  1. 24-06-16 24-06-16 -
  2. 20-09-21 20-09-21 -
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24 juni 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Treatment-resistant Depression NCT02360280

Engels

Eligibility Treatment-resistant Depression NCT02360280

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female veterans aged 18 to 75 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
have a telephone in their home and able to hear telephone conversations.
Beschrijving

Telephone in house | Able to hear Telephone conversation

Datatype

boolean

Alias
UMLS CUI [1]
C0425076
UMLS CUI [2,1]
C0576928
UMLS CUI [2,2]
C0039457
UMLS CUI [2,3]
C0871703
must meet current dsm-iv criteria for mdd, single or recurrent, without psychotic features confirmed by depression subset of the structured clinical interview-clinical trial for dsm-iv (scid).
Beschrijving

Severe major depression without psychotic features | Single major depressive episode | Recurrent major depressive episodes

Datatype

boolean

Alias
UMLS CUI [1]
C0270457
UMLS CUI [2]
C0024517
UMLS CUI [3]
C0154409
have score 32 on the inventory of depressive symptomatology-clinician rated (ids-c30)for severity of major depressive episode (mde) at screening.
Beschrijving

Single major depressive episode Severity score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0457451
current major depressive episode resistant to treatment defined as failure to achieve improvement from at least 2 antidepressant trials of different pharmacological classes. systematic evaluation of previous antidepressant trials will be assessed by the antidepressant treatment history form (athf) .
Beschrijving

Single major depressive episode Treatment-Resistant | Antidepressant therapy failed | Pharmacological Class of Investigational Therapy | Evaluation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C4020575
UMLS CUI [2,1]
C1096649
UMLS CUI [2,2]
C0231175
UMLS CUI [3]
C3274429
UMLS CUI [4]
C0220825
if applicable, current antidepressant dosages including augmenting agents and/or frequency and duration of psychotherapy sessions must remain stable for at least 6 weeks prior to beginning of the study.
Beschrijving

Antidepressive Agents Stable status | Augmenting agent | Psychiatric session Frequency Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0449986
UMLS CUI [3,1]
C0679644
UMLS CUI [3,2]
C0376249
UMLS CUI [3,3]
C0449238
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to speak english.
Beschrijving

Able to speak English Language

Datatype

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
inability or unwillingness to provide written informed consent.
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
moderate/severe cognitive impairment by mini mental state examination (mmse) scores 27.
Beschrijving

Moderate cognitive impairment | Severe cognitive impairment | mini-mental status exam score

Datatype

boolean

Alias
UMLS CUI [1]
C3839816
UMLS CUI [2]
C3554639
UMLS CUI [3]
C2225229
current or lifetime dsm-v criteria for post-traumatic stress disorder (ptsd), acute stress disorder, psychosis-related disorder, bipolar disorder i or ii disorder, substance-induced mood disorder, any mood disorder due to a general medical condition or any axis i disorder other than mdd as the primary presenting problem.
Beschrijving

Post-Traumatic Stress Disorder | Psychotic Disorders | Bipolar I disorder | Bipolar II disorder | Substance-induced mood disorder | Mood disorder due to a general medical condition | Axis I diagnosis

Datatype

boolean

Alias
UMLS CUI [1]
C0038436
UMLS CUI [2]
C0033975
UMLS CUI [3]
C0853193
UMLS CUI [4]
C0236788
UMLS CUI [5]
C3267135
UMLS CUI [6]
C0236747
UMLS CUI [7]
C0270287
history of moderate or severe traumatic brain injury, parkinson's disease, dementia of any type, multiple sclerosis, seizures or other cns related disorders.
Beschrijving

brain injury traumatic moderate | brain injury traumatic severe | Parkinson Disease | Dementia | Multiple Sclerosis | Seizures | CNS disorder

Datatype

boolean

Alias
UMLS CUI [1]
C3508473
UMLS CUI [2]
C3508474
UMLS CUI [3]
C0030567
UMLS CUI [4]
C0497327
UMLS CUI [5]
C0026769
UMLS CUI [6]
C0036572
UMLS CUI [7]
C0007682
history of comorbid substance disorder within 6 months of assessment plus positive urine toxicology screen test during baseline assessments.
Beschrijving

Substance Use Disorders Co-morbid | Urinalysis Toxicologic Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C1275743
UMLS CUI [2,1]
C0042014
UMLS CUI [2,2]
C0205472
UMLS CUI [2,3]
C1446409
clinically unstable medical illness that could compromise the patient's ability to tolerate or likely interfere with the study procedures (e.g., history of or current myocardial ischemia or arrhythmias, congestive heart failure, severe pulmonary, renal, or hepatic disease, uncontrolled hypertension).
Beschrijving

Illness Unstable status Interferes with Study Protocol | Myocardial Ischemia | Cardiac Arrhythmia | Congestive heart failure | Lung diseases Severe | Kidney Diseases Severe | Liver diseases Severe | Uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348563
UMLS CUI [2]
C0151744
UMLS CUI [3]
C0003811
UMLS CUI [4]
C0018802
UMLS CUI [5,1]
C0024115
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0022658
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0023895
UMLS CUI [7,2]
C0205082
UMLS CUI [8]
C1868885
current or within less than 14 days use of barbiturates or monoamine oxidase inhibitors (maoi).
Beschrijving

Barbiturates | Monoamine Oxidase Inhibitor

Datatype

boolean

Alias
UMLS CUI [1]
C0004745
UMLS CUI [2]
C3536878
for women: pregnancy (confirmed by lab test), initiation of female hormonal treatments within 3 months of screening, or inability/ unwillingness to use a medically accepted contraceptive method during the study.
Beschrijving

Pregnancy | Hormone Therapy Female | Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0015780
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0558080
imminent risk of suicidal/homicidal ideation and/or behavior with intent and/or plan.
Beschrijving

Feeling suicidal intent Risk | Suicidal behavior intent Risk | Homicidal thoughts intent Risk | Homicidal behavior intent Risk | Feeling suicidal Planned Risk | Suicidal behavior Planned Risk | Homicidal thoughts Planned Risk | Homicidal behavior Planned Risk

Datatype

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C1283828
UMLS CUI [1,3]
C0035647
UMLS CUI [2,1]
C1760428
UMLS CUI [2,2]
C1283828
UMLS CUI [2,3]
C0035647
UMLS CUI [3,1]
C0455204
UMLS CUI [3,2]
C1283828
UMLS CUI [3,3]
C0035647
UMLS CUI [4,1]
C1828354
UMLS CUI [4,2]
C1283828
UMLS CUI [4,3]
C0035647
UMLS CUI [5,1]
C0424000
UMLS CUI [5,2]
C1301732
UMLS CUI [5,3]
C0035647
UMLS CUI [6,1]
C1760428
UMLS CUI [6,2]
C1301732
UMLS CUI [6,3]
C0035647
UMLS CUI [7,1]
C0455204
UMLS CUI [7,2]
C1301732
UMLS CUI [7,3]
C0035647
UMLS CUI [8,1]
C1828354
UMLS CUI [8,2]
C1301732
UMLS CUI [8,3]
C0035647
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Similar models

Eligibility Treatment-resistant Depression NCT02360280

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female veterans aged 18 to 75 years.
boolean
C0001779 (UMLS CUI [1])
Telephone in house | Able to hear Telephone conversation
Item
have a telephone in their home and able to hear telephone conversations.
boolean
C0425076 (UMLS CUI [1])
C0576928 (UMLS CUI [2,1])
C0039457 (UMLS CUI [2,2])
C0871703 (UMLS CUI [2,3])
Severe major depression without psychotic features | Single major depressive episode | Recurrent major depressive episodes
Item
must meet current dsm-iv criteria for mdd, single or recurrent, without psychotic features confirmed by depression subset of the structured clinical interview-clinical trial for dsm-iv (scid).
boolean
C0270457 (UMLS CUI [1])
C0024517 (UMLS CUI [2])
C0154409 (UMLS CUI [3])
Single major depressive episode Severity score
Item
have score 32 on the inventory of depressive symptomatology-clinician rated (ids-c30)for severity of major depressive episode (mde) at screening.
boolean
C0024517 (UMLS CUI [1,1])
C0457451 (UMLS CUI [1,2])
Single major depressive episode Treatment-Resistant | Antidepressant therapy failed | Pharmacological Class of Investigational Therapy | Evaluation
Item
current major depressive episode resistant to treatment defined as failure to achieve improvement from at least 2 antidepressant trials of different pharmacological classes. systematic evaluation of previous antidepressant trials will be assessed by the antidepressant treatment history form (athf) .
boolean
C0024517 (UMLS CUI [1,1])
C4020575 (UMLS CUI [1,2])
C1096649 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C3274429 (UMLS CUI [3])
C0220825 (UMLS CUI [4])
Antidepressive Agents Stable status | Augmenting agent | Psychiatric session Frequency Duration
Item
if applicable, current antidepressant dosages including augmenting agents and/or frequency and duration of psychotherapy sessions must remain stable for at least 6 weeks prior to beginning of the study.
boolean
C0003289 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0449986 (UMLS CUI [2])
C0679644 (UMLS CUI [3,1])
C0376249 (UMLS CUI [3,2])
C0449238 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Able to speak English Language
Item
inability to speak english.
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Informed consent
Item
inability or unwillingness to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Moderate cognitive impairment | Severe cognitive impairment | mini-mental status exam score
Item
moderate/severe cognitive impairment by mini mental state examination (mmse) scores 27.
boolean
C3839816 (UMLS CUI [1])
C3554639 (UMLS CUI [2])
C2225229 (UMLS CUI [3])
Post-Traumatic Stress Disorder | Psychotic Disorders | Bipolar I disorder | Bipolar II disorder | Substance-induced mood disorder | Mood disorder due to a general medical condition | Axis I diagnosis
Item
current or lifetime dsm-v criteria for post-traumatic stress disorder (ptsd), acute stress disorder, psychosis-related disorder, bipolar disorder i or ii disorder, substance-induced mood disorder, any mood disorder due to a general medical condition or any axis i disorder other than mdd as the primary presenting problem.
boolean
C0038436 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C0853193 (UMLS CUI [3])
C0236788 (UMLS CUI [4])
C3267135 (UMLS CUI [5])
C0236747 (UMLS CUI [6])
C0270287 (UMLS CUI [7])
brain injury traumatic moderate | brain injury traumatic severe | Parkinson Disease | Dementia | Multiple Sclerosis | Seizures | CNS disorder
Item
history of moderate or severe traumatic brain injury, parkinson's disease, dementia of any type, multiple sclerosis, seizures or other cns related disorders.
boolean
C3508473 (UMLS CUI [1])
C3508474 (UMLS CUI [2])
C0030567 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
C0026769 (UMLS CUI [5])
C0036572 (UMLS CUI [6])
C0007682 (UMLS CUI [7])
Substance Use Disorders Co-morbid | Urinalysis Toxicologic Positive
Item
history of comorbid substance disorder within 6 months of assessment plus positive urine toxicology screen test during baseline assessments.
boolean
C0038586 (UMLS CUI [1,1])
C1275743 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2,1])
C0205472 (UMLS CUI [2,2])
C1446409 (UMLS CUI [2,3])
Illness Unstable status Interferes with Study Protocol | Myocardial Ischemia | Cardiac Arrhythmia | Congestive heart failure | Lung diseases Severe | Kidney Diseases Severe | Liver diseases Severe | Uncontrolled hypertension
Item
clinically unstable medical illness that could compromise the patient's ability to tolerate or likely interfere with the study procedures (e.g., history of or current myocardial ischemia or arrhythmias, congestive heart failure, severe pulmonary, renal, or hepatic disease, uncontrolled hypertension).
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0151744 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0024115 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0023895 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C1868885 (UMLS CUI [8])
Barbiturates | Monoamine Oxidase Inhibitor
Item
current or within less than 14 days use of barbiturates or monoamine oxidase inhibitors (maoi).
boolean
C0004745 (UMLS CUI [1])
C3536878 (UMLS CUI [2])
Pregnancy | Hormone Therapy Female | Contraceptive methods Unwilling
Item
for women: pregnancy (confirmed by lab test), initiation of female hormonal treatments within 3 months of screening, or inability/ unwillingness to use a medically accepted contraceptive method during the study.
boolean
C0032961 (UMLS CUI [1])
C0279025 (UMLS CUI [2,1])
C0015780 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Feeling suicidal intent Risk | Suicidal behavior intent Risk | Homicidal thoughts intent Risk | Homicidal behavior intent Risk | Feeling suicidal Planned Risk | Suicidal behavior Planned Risk | Homicidal thoughts Planned Risk | Homicidal behavior Planned Risk
Item
imminent risk of suicidal/homicidal ideation and/or behavior with intent and/or plan.
boolean
C0424000 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C1760428 (UMLS CUI [2,1])
C1283828 (UMLS CUI [2,2])
C0035647 (UMLS CUI [2,3])
C0455204 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0035647 (UMLS CUI [3,3])
C1828354 (UMLS CUI [4,1])
C1283828 (UMLS CUI [4,2])
C0035647 (UMLS CUI [4,3])
C0424000 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
C0035647 (UMLS CUI [5,3])
C1760428 (UMLS CUI [6,1])
C1301732 (UMLS CUI [6,2])
C0035647 (UMLS CUI [6,3])
C0455204 (UMLS CUI [7,1])
C1301732 (UMLS CUI [7,2])
C0035647 (UMLS CUI [7,3])
C1828354 (UMLS CUI [8,1])
C1301732 (UMLS CUI [8,2])
C0035647 (UMLS CUI [8,3])
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