ID

21782

Descrição

Treatment-Resistant Depression Registry; ODM derived from: https://clinicaltrials.gov/show/NCT00320372

Link

https://clinicaltrials.gov/show/NCT00320372

Palavras-chave

  1. 30/04/2017 30/04/2017 -
Transferido a

30 de abril de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Major Depressive Disorder NCT00320372

Eligibility Major Depressive Disorder NCT00320372

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient diagnosed with a current major depressive episode according to dsm-iv-tr criteria.
Descrição

Single major depressive episode

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024517
for d-21 patients only who have completed the d-21 dosing study without any d-21 inclusion and exclusion protocol deviation.
Descrição

Clinical Trial Specified Completed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0205197
patient has been in the current depressive episode for 2 years or longer, or has had at least 3 lifetime episodes including the current mde.
Descrição

Depressive episode Duration | Depressive episode Lifetime Quantity | Single major depressive episode

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0349217
UMLS CUI [2,2]
C4071830
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0024517
patient has had an inadequate response to 4 or more adequate antidepressive treatments.
Descrição

Antidepressant therapy Quantity Poor response to treatment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1320680
the patient has a cgi severity of illness score of moderately ill (score of 4) or greater.
Descrição

Illness Moderate Clinical Global Impression Questionnaire

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C3639708
the patient must be able to provide informed consent and complete all forms.
Descrição

Informed Consent | Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has a history of schizophrenia, schizoaffective disorder, any other psychotic disorder, or a current major depressive episode that includes psychotic features; or is currently psychotic.
Descrição

Schizophrenia | Schizoaffective Disorder | Psychotic Disorders | Severe major depression, single episode, with psychotic features | Psychotic state

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0154406
UMLS CUI [5]
C0459435
patient is currently enrolled in a double blind investigational study; patients who have completed the double-blind d-21 study will be allowed to enter the registry for long term follow-up
Descrição

Enrollment Clinical Trial Double-Blind Method

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0013072
other than those patients who were enrolled in the d-21 study, patient has previously received vns therapy.
Descrição

Vagus Nerve Stimulation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2350432
patient has a history of rapid cycling bipolar disorder.
Descrição

Rapid cycling bipolar I disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2063820

Similar models

Eligibility Major Depressive Disorder NCT00320372

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Single major depressive episode
Item
patient diagnosed with a current major depressive episode according to dsm-iv-tr criteria.
boolean
C0024517 (UMLS CUI [1])
Clinical Trial Specified Completed
Item
for d-21 patients only who have completed the d-21 dosing study without any d-21 inclusion and exclusion protocol deviation.
boolean
C0008976 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Depressive episode Duration | Depressive episode Lifetime Quantity | Single major depressive episode
Item
patient has been in the current depressive episode for 2 years or longer, or has had at least 3 lifetime episodes including the current mde.
boolean
C0349217 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0349217 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0024517 (UMLS CUI [3])
Antidepressant therapy Quantity Poor response to treatment
Item
patient has had an inadequate response to 4 or more adequate antidepressive treatments.
boolean
C1096649 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1320680 (UMLS CUI [1,3])
Illness Moderate Clinical Global Impression Questionnaire
Item
the patient has a cgi severity of illness score of moderately ill (score of 4) or greater.
boolean
C0221423 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C3639708 (UMLS CUI [1,3])
Informed Consent | Protocol Compliance
Item
the patient must be able to provide informed consent and complete all forms.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Schizophrenia | Schizoaffective Disorder | Psychotic Disorders | Severe major depression, single episode, with psychotic features | Psychotic state
Item
patient has a history of schizophrenia, schizoaffective disorder, any other psychotic disorder, or a current major depressive episode that includes psychotic features; or is currently psychotic.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0154406 (UMLS CUI [4])
C0459435 (UMLS CUI [5])
Enrollment Clinical Trial Double-Blind Method
Item
patient is currently enrolled in a double blind investigational study; patients who have completed the double-blind d-21 study will be allowed to enter the registry for long term follow-up
boolean
C1516879 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0013072 (UMLS CUI [1,3])
Vagus Nerve Stimulation
Item
other than those patients who were enrolled in the d-21 study, patient has previously received vns therapy.
boolean
C2350432 (UMLS CUI [1])
Rapid cycling bipolar I disorder
Item
patient has a history of rapid cycling bipolar disorder.
boolean
C2063820 (UMLS CUI [1])

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

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