ID

16832

Beschrijving

Brain Activity Changes and Treatment Response in Depressed People Who Are Receiving Antidepressant Medication; ODM derived from: https://clinicaltrials.gov/show/NCT00375843

Link

https://clinicaltrials.gov/show/NCT00375843

Trefwoorden

  1. 09-08-16 09-08-16 -
Geüploaded op

9 augustus 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Depression NCT00375843

Eligibility Depression NCT00375843

  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00375843
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
currently an outpatient with nonpsychotic, unipolar major depressive disorder (mdd)
Beschrijving

Outpatient with nonpsychotic, unipolar major depressive disorder (mdd)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0029921
UMLS CUI [1,2]
C0743076
UMLS CUI [1,3]
C1269683
score of 14 or greater on the 17-item hamilton rating scale for depression (ham-d17)
Beschrijving

Hamilton rating scale for depression

Datatype

boolean

Alias
UMLS CUI [1]
C0451203
antidepressant treatment is deemed appropriate by the study clinician
Beschrijving

Antidepressant treatment is deemed appropriate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C3640049
willing to use an effective form of contraception throughout the study
Beschrijving

Contraception

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
mentally or legally incapacitated
Beschrijving

Mentally or legally incapacitated

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, mdd with psychotic features, or dementia
Beschrijving

Bipolar disorder, schizophrenia, schizoaffective disorder, mdd with psychotic features, or dementia

Datatype

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0036337
UMLS CUI [4]
C0270458
UMLS CUI [5]
C0497327
patients currently suffering from anorexia nervosa, bulimia nervosa, or obsessive compulsive disorder
Beschrijving

Anorexia nervosa, bulimia nervosa, or obsessive compulsive disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0003125
UMLS CUI [2]
C2267227
UMLS CUI [3]
C0028768
history of substance abuse disorder within 6 months prior to study entry
Beschrijving

Substance abuse disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
current suicidal ideation that would make outpatient treatment unsafe
Beschrijving

Suicidal ideation

Datatype

boolean

Alias
UMLS CUI [1]
C0424000
past medication response that may make escitalopram or sertraline treatment unsafe or inappropriate (e.g., previous intolerance or lack of response to either medication)
Beschrijving

past medication response that may make escitalopram or sertraline treatment unsafe or inappropriate

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319171
UMLS CUI [1,2]
C1099456
UMLS CUI [2,1]
C1319171
UMLS CUI [2,2]
C0074393
history of a failed treatment with escitalopram (40 mg or more) or sertraline (200 mg or more) during the current depressive episode
Beschrijving

history of failed treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0438286
UMLS CUI [1,2]
C1099456
UMLS CUI [2,1]
C0438286
UMLS CUI [2,2]
C0074393
any medical conditions that would make treatment with escitalopram or sertraline medically inadvisable
Beschrijving

Contraindication to treatment with Escitalopram or Setraline

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1099456
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0074393
unstable medical illness
Beschrijving

Comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
unstable psychiatric illness likely to require inpatient treatment within the 6 months following study entry
Beschrijving

Psychiatric illness likely to require inpatient treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1708385
history of seizures, brain surgery, skull fracture, significant head trauma, or previous abnormal eeg
Beschrijving

History of seizures, brain surgery, skull fracture, significant head trauma, or previous abnormal eeg

Datatype

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0195775
UMLS CUI [3]
C0037304
UMLS CUI [4]
C0018674
UMLS CUI [5]
C0013819
pregnant or plans to become pregnant within the 12 months following study entry
Beschrijving

Pregnant or planning to become pregnant

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C2081645
breastfeeding
Beschrijving

Breast feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0006147

Similar models

Eligibility Depression NCT00375843

  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00375843
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Outpatient with nonpsychotic, unipolar major depressive disorder (mdd)
Item
currently an outpatient with nonpsychotic, unipolar major depressive disorder (mdd)
boolean
C0029921 (UMLS CUI [1,1])
C0743076 (UMLS CUI [1,2])
C1269683 (UMLS CUI [1,3])
Hamilton rating scale for depression
Item
score of 14 or greater on the 17-item hamilton rating scale for depression (ham-d17)
boolean
C0451203 (UMLS CUI [1])
Antidepressant treatment is deemed appropriate
Item
antidepressant treatment is deemed appropriate by the study clinician
boolean
C0003289 (UMLS CUI [1,1])
C3640049 (UMLS CUI [1,2])
Contraception
Item
willing to use an effective form of contraception throughout the study
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mentally or legally incapacitated
Item
mentally or legally incapacitated
boolean
C1321605 (UMLS CUI [1])
Bipolar disorder, schizophrenia, schizoaffective disorder, mdd with psychotic features, or dementia
Item
lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, mdd with psychotic features, or dementia
boolean
C0005586 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
C0270458 (UMLS CUI [4])
C0497327 (UMLS CUI [5])
Anorexia nervosa, bulimia nervosa, or obsessive compulsive disorder
Item
patients currently suffering from anorexia nervosa, bulimia nervosa, or obsessive compulsive disorder
boolean
C0003125 (UMLS CUI [1])
C2267227 (UMLS CUI [2])
C0028768 (UMLS CUI [3])
Substance abuse disorder
Item
history of substance abuse disorder within 6 months prior to study entry
boolean
C0038586 (UMLS CUI [1])
Suicidal ideation
Item
current suicidal ideation that would make outpatient treatment unsafe
boolean
C0424000 (UMLS CUI [1])
past medication response that may make escitalopram or sertraline treatment unsafe or inappropriate
Item
past medication response that may make escitalopram or sertraline treatment unsafe or inappropriate (e.g., previous intolerance or lack of response to either medication)
boolean
C1319171 (UMLS CUI [1,1])
C1099456 (UMLS CUI [1,2])
C1319171 (UMLS CUI [2,1])
C0074393 (UMLS CUI [2,2])
history of failed treatment
Item
history of a failed treatment with escitalopram (40 mg or more) or sertraline (200 mg or more) during the current depressive episode
boolean
C0438286 (UMLS CUI [1,1])
C1099456 (UMLS CUI [1,2])
C0438286 (UMLS CUI [2,1])
C0074393 (UMLS CUI [2,2])
Contraindication to treatment with Escitalopram or Setraline
Item
any medical conditions that would make treatment with escitalopram or sertraline medically inadvisable
boolean
C1301624 (UMLS CUI [1,1])
C1099456 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0074393 (UMLS CUI [2,2])
Comorbidity
Item
unstable medical illness
boolean
C0009488 (UMLS CUI [1])
Psychiatric illness likely to require inpatient treatment
Item
unstable psychiatric illness likely to require inpatient treatment within the 6 months following study entry
boolean
C0004936 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
History of seizures, brain surgery, skull fracture, significant head trauma, or previous abnormal eeg
Item
history of seizures, brain surgery, skull fracture, significant head trauma, or previous abnormal eeg
boolean
C0036572 (UMLS CUI [1])
C0195775 (UMLS CUI [2])
C0037304 (UMLS CUI [3])
C0018674 (UMLS CUI [4])
C0013819 (UMLS CUI [5])
Pregnant or planning to become pregnant
Item
pregnant or plans to become pregnant within the 12 months following study entry
boolean
C0032961 (UMLS CUI [1])
C2081645 (UMLS CUI [2])
Breast feeding
Item
breastfeeding
boolean
C0006147 (UMLS CUI [1])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial