ID

30478

Descrição

Multi-Country Observational Study to Collect the Frequency of Sexual Dysfunction With Antidepressant Treatment, Either With SSRIs or Duals at 8 Weeks and 6 Months; ODM derived from: https://clinicaltrials.gov/show/NCT00561509

Link

https://clinicaltrials.gov/show/NCT00561509

Palavras-chave

  1. 07/06/2018 07/06/2018 -
  2. 07/06/2018 07/06/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

7 de junho de 2018

DOI

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Licença

Creative Commons BY-NC 3.0

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Eligibility Major Depressive Disorder NCT00561509

Eligibility Major Depressive Disorder NCT00561509

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
meet the criteria for mdd, as defined by the icd-10 or dsm-iv-tr
Descrição

Major Depressive Disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1269683
are at least moderately depressed (baseline cgi-s less than or equal to 4)
Descrição

Moderate depression CGI - Severity of Illness | Severe depression CGI - Severity of Illness

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0588007
UMLS CUI [1,2]
C3639887
UMLS CUI [2,1]
C0588008
UMLS CUI [2,2]
C3639887
provide written consent to the release of their data after being informed about the study
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
present with an episode of mdd (current, new or first episode) within the normal course of care, and agree to initiate antidepressant therapy with any available ssri or snri class of antidepressant in accordance with the investigator's decision for the management of the patient
Descrição

ID.4

Tipo de dados

boolean

have been sexually active in the week prior to enrollment, either with a partner or autoerotic activity
Descrição

Sexually active Partner | Sexually active Engagement in autoerotic sexual acts

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0241028
UMLS CUI [1,2]
C0682323
UMLS CUI [2,1]
C0241028
UMLS CUI [2,2]
C4060925
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
meet any of the following criteria for sexual dysfunction at study entry (mcgahuey et all. 2000: asex total score less than or equal 19 or asex score less than or equal to 5 on any item, or asex score less than or equal to 4 on any 3 items
Descrição

Sexual Dysfunction | Arizona Sexual Experiences Scale-Male Version Questionnaire | Arizona Sexual Experiences Scale-Female Version Questionnaire

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0549622
UMLS CUI [2]
C4289960
UMLS CUI [3]
C4289961
are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
Descrição

Study Subject Participation Status | Interventional procedure | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0184661
UMLS CUI [3]
C0013230
have a history of treatment resistant depression (trd) defined as a failure to respond to 2 different antidepressants from different classes after treatment at therapeutic dose for a minimum of 4 weeks
Descrição

Depressive Disorder, Treatment-Resistant | Antidepressive Agents Class Different Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2063866
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0456387
UMLS CUI [2,3]
C1705242
UMLS CUI [2,4]
C1265611
have any previous or current diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder, bipolar disorder, dysthymia, mental retardation, or dementia
Descrição

Schizophrenia | Schizophreniform Disorders | Schizoaffective Disorder | Bipolar Disorder | Dysthymic Disorder | Mental Retardation | Dementia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036358
UMLS CUI [3]
C0036337
UMLS CUI [4]
C0005586
UMLS CUI [5]
C0013415
UMLS CUI [6]
C0025362
UMLS CUI [7]
C0497327
have received any antidepressant within 1 week prior to enrollment (1 month prior to enrollment for fluoxetine)
Descrição

Antidepressive Agents Recently

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0332185

Similar models

Eligibility Major Depressive Disorder NCT00561509

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
meet the criteria for mdd, as defined by the icd-10 or dsm-iv-tr
boolean
C1269683 (UMLS CUI [1])
Moderate depression CGI - Severity of Illness | Severe depression CGI - Severity of Illness
Item
are at least moderately depressed (baseline cgi-s less than or equal to 4)
boolean
C0588007 (UMLS CUI [1,1])
C3639887 (UMLS CUI [1,2])
C0588008 (UMLS CUI [2,1])
C3639887 (UMLS CUI [2,2])
Informed Consent
Item
provide written consent to the release of their data after being informed about the study
boolean
C0021430 (UMLS CUI [1])
ID.4
Item
present with an episode of mdd (current, new or first episode) within the normal course of care, and agree to initiate antidepressant therapy with any available ssri or snri class of antidepressant in accordance with the investigator's decision for the management of the patient
boolean
Sexually active Partner | Sexually active Engagement in autoerotic sexual acts
Item
have been sexually active in the week prior to enrollment, either with a partner or autoerotic activity
boolean
C0241028 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0241028 (UMLS CUI [2,1])
C4060925 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Sexual Dysfunction | Arizona Sexual Experiences Scale-Male Version Questionnaire | Arizona Sexual Experiences Scale-Female Version Questionnaire
Item
meet any of the following criteria for sexual dysfunction at study entry (mcgahuey et all. 2000: asex total score less than or equal 19 or asex score less than or equal to 5 on any item, or asex score less than or equal to 4 on any 3 items
boolean
C0549622 (UMLS CUI [1])
C4289960 (UMLS CUI [2])
C4289961 (UMLS CUI [3])
Study Subject Participation Status | Interventional procedure | Investigational New Drugs
Item
are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
boolean
C2348568 (UMLS CUI [1])
C0184661 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Depressive Disorder, Treatment-Resistant | Antidepressive Agents Class Different Quantity
Item
have a history of treatment resistant depression (trd) defined as a failure to respond to 2 different antidepressants from different classes after treatment at therapeutic dose for a minimum of 4 weeks
boolean
C2063866 (UMLS CUI [1])
C0003289 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C1705242 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Schizophrenia | Schizophreniform Disorders | Schizoaffective Disorder | Bipolar Disorder | Dysthymic Disorder | Mental Retardation | Dementia
Item
have any previous or current diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder, bipolar disorder, dysthymia, mental retardation, or dementia
boolean
C0036341 (UMLS CUI [1])
C0036358 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
C0005586 (UMLS CUI [4])
C0013415 (UMLS CUI [5])
C0025362 (UMLS CUI [6])
C0497327 (UMLS CUI [7])
Antidepressive Agents Recently
Item
have received any antidepressant within 1 week prior to enrollment (1 month prior to enrollment for fluoxetine)
boolean
C0003289 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])

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